Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-27 @ 11:31 PM
Study NCT ID:
NCT01193660
Status:
COMPLETED
Last Update Posted:
2020-11-24
First Post:
2010-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Allogenic Umbilical Cord Blood and Erythropoietin Combination Therapy for Cerebral Palsy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}], 'ancestors': [{'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004921', 'term': 'Erythropoietin'}, {'id': 'D000418', 'term': 'Albumins'}], 'ancestors': [{'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kmin@cha.ac.kr', 'phone': '82-31-780-1872', 'title': 'Minyoung Kim, MD, PhD', 'organization': 'CHA Bundang Medical Center, CHA University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline - 1 month - 3 months - 6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Umbilical Cord Blood & Erythropoietin & Rehabilitation', 'description': 'Allogeneic umbilical cord blood infusion (total nucleated cells \\> 3x10\\^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation', 'otherNumAtRisk': 35, 'otherNumAffected': 30, 'seriousNumAtRisk': 35, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Erythropoietin & Rehabilitation', 'description': 'Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation', 'otherNumAtRisk': 36, 'otherNumAffected': 29, 'seriousNumAtRisk': 6, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Only Rehabilitation', 'description': 'Active rehabilitation', 'otherNumAtRisk': 34, 'otherNumAffected': 32, 'seriousNumAtRisk': 8, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 7, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Febrile convulsioin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 20, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 23, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 24, 'numAffected': 21}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Herpangina', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nausea, vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hirsuitism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Otitis media acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Conjunctival irritations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypoxia', 'notes': 'Temporary O2 desaturation(89-91%) at the end of UCB infusion in UCB group; O2 desaturation(91%) shortly during sedation for PET in EPO group; O2 desaturation(71-95%) intermittently during 47 min maybe from postictal respiratory depression in control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Death', 'notes': 'One death at 14 wks post-transplantation. She was a 25 mo-old with spastic quadriplegia from profound hypoxia. She was unable to control her head and showed poor oral function. She had been medically stable. The cause was supposed to be suffocation.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Changes in Motor Performance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Umbilical Cord Blood & Erythropoietin & Rehabilitation', 'description': 'Allogeneic umbilical cord blood infusion (total nucleated cells \\> 3x10\\^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation'}, {'id': 'OG001', 'title': 'Erythropoietin & Rehabilitation', 'description': 'Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation'}, {'id': 'OG002', 'title': 'Only Rehabilitation', 'description': 'Active rehabilitation'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '34.5', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '38.2', 'spread': '2.8', 'groupId': 'OG001'}, {'value': '35.5', 'spread': '2.9', 'groupId': 'OG002'}]}]}, {'title': '1 month - Baseline', 'categories': [{'measurements': [{'value': '7.00', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '6.0', 'spread': '1.0', 'groupId': 'OG002'}]}]}, {'title': '3 months - Baseline', 'categories': [{'measurements': [{'value': '11.5', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '7.5', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '8.1', 'spread': '1.2', 'groupId': 'OG002'}]}]}, {'title': '6 months - Baseline', 'categories': [{'measurements': [{'value': '14.5', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '9.2', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '9.6', 'spread': '1.2', 'groupId': 'OG002'}]}]}, {'title': '3 months - 1 month', 'categories': [{'measurements': [{'value': '4.5', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '2.1', 'spread': '0.6', 'groupId': 'OG002'}]}]}, {'title': '6 months - 1 month', 'categories': [{'measurements': [{'value': '7.5', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '3.6', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': '6 months - 3 months', 'categories': [{'measurements': [{'value': '3.1', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '0.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': "Wilks' Lambda (group*visit effect)", 'ciPctValue': '95', 'paramValue': '2.59', 'groupDescription': 'In our analysis, the null hypothesis is that the effects of 3 experimental groups are same, and the alternative hypothesis is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.', 'statisticalMethod': 'Repeated Measure ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline -1 month - 3 months - 6 months', 'description': 'GMPM (Gross Motor Performance Measure) as a standardized measurement tool for assessing quality of movement regarding 3 properties of 5 ones; alignment, coordination, dissociated movement, stability, and weight shift (range: 0\\~100, Higher value means better motor quality). We reported changes of GMPM score between each assessment time points. Categories of outcome table are baseline and values of just subtracting the latter raw scores from the former ones.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Changes in Cognitive Neurodevelopmental Outcome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Umbilical Cord Blood & Erythropoietin & Rehabilitation', 'description': 'Allogeneic umbilical cord blood infusion (total nucleated cells \\> 3x10\\^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation'}, {'id': 'OG001', 'title': 'Erythropoietin & Rehabilitation', 'description': 'Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation'}, {'id': 'OG002', 'title': 'Only Rehabilitation', 'description': 'Active rehabilitation'}], 'classes': [{'title': 'BSID-II Mental Scale: Baseline', 'categories': [{'measurements': [{'value': '94.1', 'spread': '9.1', 'groupId': 'OG000'}, {'value': '105.9', 'spread': '8.9', 'groupId': 'OG001'}, {'value': '86.6', 'spread': '9.0', 'groupId': 'OG002'}]}]}, {'title': 'BSID-II Mental Scale: 1 month - Baseline', 'categories': [{'measurements': [{'value': '8.2', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '3.3', 'spread': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'BSID-II Mental Scale: 3 months - Baseline', 'categories': [{'measurements': [{'value': '12.0', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '7.4', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '5.8', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'BSID-II Mental Scale: 6 months - Baseline', 'categories': [{'measurements': [{'value': '17.6', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '11.5', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '9.9', 'spread': '1.6', 'groupId': 'OG002'}]}]}, {'title': 'BSID-II Mental Scale: 3 months - 1 month', 'categories': [{'measurements': [{'value': '3.8', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '2.5', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': 'BSID-II Mental Scale: 6 months - 1 month', 'categories': [{'measurements': [{'value': '9.4', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '8.1', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '6.6', 'spread': '1.4', 'groupId': 'OG002'}]}]}, {'title': 'BSID-II Mental Scale: 6 months - 3 months', 'categories': [{'measurements': [{'value': '5.6', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '4.1', 'spread': '1.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': "Wilks' Lambda (group*visit effect)", 'ciPctValue': '95', 'paramValue': '3.94', 'groupDescription': 'The null hypothesis is that in terms of K-BSID-II MENTAL Scale, the effects of 3 groups are same, and the alternative one is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.', 'statisticalMethod': 'Repeated Measure ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline -1 month - 3 months - 6 months', 'description': 'Korean version of Bayley Scale of Infant Development-II (K-BSID-II) Mental Scales (higher value means better mental function: 0 - worst, 178 - best). We reported changes of BSID-II Mental Scale raw score between each assessment time points. Categories of outcome data are values of subtracting the latter scores from the former ones.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Changes in Motor Neurodevelopmental Outcome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Umbilical Cord Blood & Erythropoietin & Rehabilitation', 'description': 'Allogeneic umbilical cord blood infusion (total nucleated cells \\> 3x10\\^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation'}, {'id': 'OG001', 'title': 'Erythropoietin & Rehabilitation', 'description': 'Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation'}, {'id': 'OG002', 'title': 'Only Rehabilitation', 'description': 'Active rehabilitation'}], 'classes': [{'title': 'BSID-II Motor Scale: Baseline', 'categories': [{'measurements': [{'value': '45.2', 'spread': '4.7', 'groupId': 'OG000'}, {'value': '53.3', 'spread': '5.0', 'groupId': 'OG001'}, {'value': '45.5', 'spread': '4.6', 'groupId': 'OG002'}]}]}, {'title': 'BSID-II Motor Scale: 1 month - Baseline', 'categories': [{'measurements': [{'value': '5.0', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '2.1', 'groupId': 'OG001'}, {'value': '2.7', 'spread': '0.6', 'groupId': 'OG002'}]}]}, {'title': 'BSID-II Motor Scale: 3 months - Baseline', 'categories': [{'measurements': [{'value': '9.5', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '2.1', 'groupId': 'OG001'}, {'value': '4.3', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'BSID-II Motor Scale: 6 months - Baseline', 'categories': [{'measurements': [{'value': '11.7', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '7.6', 'spread': '2.2', 'groupId': 'OG001'}, {'value': '5.2', 'spread': '0.9', 'groupId': 'OG002'}]}]}, {'title': 'BSID-II Motor Scale: 3 months - 1 month', 'categories': [{'measurements': [{'value': '4.5', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '0.4', 'groupId': 'OG002'}]}]}, {'title': 'BSID-II Motor Scale: 6 months - 1 month', 'categories': [{'measurements': [{'value': '6.7', 'spread': '1.3', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '2.5', 'spread': '0.5', 'groupId': 'OG002'}]}]}, {'title': 'BSID-II Motor Scale: 6 months - 3 months', 'categories': [{'measurements': [{'value': '2.2', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '0.4', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '0.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': "Wilks' Lambda (group*visit effect)", 'ciPctValue': '95', 'paramValue': '2.70', 'groupDescription': 'The null hypothesis is that in terms of K-BSID-II MOTOR Scale, the effects of 3 groups are same, and the alternative one is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.', 'statisticalMethod': 'Repeated Measure ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline - 1 month - 3 months - 6 months', 'description': 'Korean version of Bayley Scale of Infant Development-II (K-BSID-II) Motor Scales (higher value means better motor function: 0 - worst, 111 - best). We reported changes of BSID-II Motor Scale raw score between each assessment time points. Categories of outcome data are values of subtracting the latter scores from the former ones.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Changes in Brain MRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Umbilical Cord Blood & Erythropoietin & Rehabilitation', 'description': 'Allogeneic umbilical cord blood infusion (total nucleated cells \\> 3x10\\^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation'}, {'id': 'OG001', 'title': 'Erythropoietin & Rehabilitation', 'description': 'Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation'}, {'id': 'OG002', 'title': 'Only Rehabilitation', 'description': 'Active rehabilitation'}], 'classes': [{'title': 'Anterior portion of Rt. posterior Internal Capsule', 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.01', 'groupId': 'OG001'}, {'value': '0.01', 'spread': '0.01', 'groupId': 'OG002'}]}]}, {'title': 'Posterior portion of Rt posterior Internal Capsule', 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.01', 'groupId': 'OG001'}, {'value': '0.02', 'spread': '0.02', 'groupId': 'OG002'}]}]}, {'title': 'Anterior portion of Lt. posterior Internal Capsule', 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.01', 'groupId': 'OG001'}, {'value': '0.04', 'spread': '0.02', 'groupId': 'OG002'}]}]}, {'title': 'Posterior portion of Lt posterior Internal Capsule', 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.02', 'groupId': 'OG001'}, {'value': '0.05', 'spread': '0.02', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline - 6 months', 'description': 'Changes on brain Diffusion Tensor Image (DTI); DTI provides quantitative information about the microscopic integrity of white matter. White matter normally possesses a high degree of diffusion anisotropy than gray matter. We can measure fractional anisotropy (FA) value in DTI imaging and it ranges from 0 to 1. Higher FA value of a certain region of interest means the area has more integrity of white matter.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Umbilical Cord Blood & Erythropoietin & Rehabilitation', 'description': 'Allogeneic umbilical cord blood infusion (total nucleated cells \\> 3x10\\^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation'}, {'id': 'OG001', 'title': 'Erythropoietin & Rehabilitation', 'description': 'Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation'}, {'id': 'OG002', 'title': 'Only Rehabilitation', 'description': 'Active rehabilitation'}], 'classes': [{'title': 'Rt. Lentiform Nucleus, Gray Matter, Putamen', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Lt. Frontal Lobe, Medial Frontal Gyrus', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Lt. Sub-lobar, Insula', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '-1', 'groupId': 'OG002'}]}]}, {'title': 'Lt. Lentiform Nucleus, Gray Matter, Putamen', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Lt.Lentiform Nucleus, Gray Matter, Globus Pallidus', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Lt. Midbrain (Thalamus)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Rt. Parietal Lobe, Precuneus', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Lt. Temporal Lobe, Middle Temporal Gyrus', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '-1', 'groupId': 'OG002'}]}]}, {'title': 'Rt. Parietal Lobe, Pre- and Post-central Gyrus', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Rt. Frontal Lobe, Paracentral Lobule', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Rt. Limbic Lobe, Anterior Cingulate', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Lt. Frontal Lobe, Precentral Gyrus', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Lt. Lentiform Nucleus, Putamen', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Rt. Cerebellar Anterior Lobe, Culmen', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Lt. Cerebellar Posterior Lobe, Cerebellar Tonsil', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Rt. Frontal Lobe, Orbital Gyrus', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Rt. Occipital Lobe, Middle Occipital Gyrus', 'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Lt. Limbic Lobe, Parahippocampal Gyrus', 'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Rt. Limbic Lobe, Parahippocampal Gyrus', 'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '-1', 'groupId': 'OG002'}]}]}, {'title': 'Rt Cerebellum, Posterior Lobe, Declive', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '-1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Rt Cerebellum, Anterior Lobe, Culmen, Occipital', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '-1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Lt Cerebellum, Posterior Lobe, Declive, Occipital', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '-1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Lt. Frontal Lobe, Middle Frontal Gyrus', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '-1', 'groupId': 'OG002'}]}]}, {'title': 'Rt. Frontal Lobe, Middle Frontal Gyrus', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '-1', 'groupId': 'OG002'}]}]}, {'title': 'Rt. Frontal Lobe, Sub-gyral', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '-1', 'groupId': 'OG002'}]}]}, {'title': 'Lt. Temporal Lobe, Fusiform Gyrus', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '-1', 'groupId': 'OG002'}]}]}, {'title': 'Lt. Temporal Lobe, Inferior Temporal Gyrus', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '-1', 'groupId': 'OG002'}]}]}, {'title': 'Rt. Temporal Lobe, Middle Temporal Gyrus', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '-1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'The baseline and post-therapy data of each group were compared using paired t-test statistics.', 'groupDescription': 'In our analysis, the null hypothesis is that the effects of three experimental groups are same each other, and the alternative hypothesis is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) has much higher than that of either Erythropoietin + Rehabilitation Group or Rehabilitation Group. This study is a pilot study and therefore, power calculation was not applicable in our study. The sample size of each group is more than 30.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'Voxels with an uncorrected p-value of \\<0.05 were considered significant, and an extent threshold Ke of 100 voxels was set by SPM implanted in Matlab.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline - 2 weeks', 'description': '18F-FDG PET imaging was performed twice prior to and then 2 weeks post-treatment. Ninety slices of each emission image were obtained, and all scans were reviewed by a nuclear physician. Spatial pre-processing and statistical analyses were performed using SPM8 implanted in Matlab to compare differences in regional brain glucose metabolism between groups and differences between pre- and post-therapy imaging data. We reported increased areas and decreased areas of glucose metabolism in three groups. We defined that "1" refers to INCREASED areas, "-1", DECREASED areas and "0", just NO CHANGE.', 'unitOfMeasure': 'units on a scale', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Changes in Functional Performance in Daily Activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Umbilical Cord Blood & Erythropoietin & Rehabilitation', 'description': 'Allogeneic umbilical cord blood infusion (total nucleated cells \\> 3x10\\^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation'}, {'id': 'OG001', 'title': 'Erythropoietin & Rehabilitation', 'description': 'Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation'}, {'id': 'OG002', 'title': 'Only Rehabilitation', 'description': 'Active rehabilitation'}], 'classes': [{'title': 'Self care of FSS: Baseline', 'categories': [{'measurements': [{'value': '39.1', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '38.2', 'spread': '2.7', 'groupId': 'OG001'}, {'value': '37.4', 'spread': '2.2', 'groupId': 'OG002'}]}]}, {'title': 'Self care of FSS: 1 month', 'categories': [{'measurements': [{'value': '42.2', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '40.4', 'spread': '2.9', 'groupId': 'OG001'}, {'value': '40.0', 'spread': '2.2', 'groupId': 'OG002'}]}]}, {'title': 'Self care of FSS: 3 months', 'categories': [{'measurements': [{'value': '44.7', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '43.5', 'spread': '2.9', 'groupId': 'OG001'}, {'value': '41.7', 'spread': '2.3', 'groupId': 'OG002'}]}]}, {'title': 'Self care of FSS: 6 months', 'categories': [{'measurements': [{'value': '46.5', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '45.0', 'spread': '2.8', 'groupId': 'OG001'}, {'value': '42.8', 'spread': '2.3', 'groupId': 'OG002'}]}]}, {'title': 'Mobility of FSS: Baseline', 'categories': [{'measurements': [{'value': '24.8', 'spread': '3.7', 'groupId': 'OG000'}, {'value': '29.2', 'spread': '4.3', 'groupId': 'OG001'}, {'value': '24.9', 'spread': '3.7', 'groupId': 'OG002'}]}]}, {'title': 'Mobility of FSS: 1 month', 'categories': [{'measurements': [{'value': '28.1', 'spread': '3.9', 'groupId': 'OG000'}, {'value': '32.4', 'spread': '4.3', 'groupId': 'OG001'}, {'value': '27.9', 'spread': '3.8', 'groupId': 'OG002'}]}]}, {'title': 'Mobility of FSS: 3 months', 'categories': [{'measurements': [{'value': '31.7', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '34.6', 'spread': '4.3', 'groupId': 'OG001'}, {'value': '29.3', 'spread': '3.9', 'groupId': 'OG002'}]}]}, {'title': 'Mobility of FSS: 6 months', 'categories': [{'measurements': [{'value': '34.6', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '36.6', 'spread': '4.4', 'groupId': 'OG001'}, {'value': '31.4', 'spread': '3.9', 'groupId': 'OG002'}]}]}, {'title': 'Social function of FSS: Baseline', 'categories': [{'measurements': [{'value': '40.0', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '40.1', 'spread': '3.3', 'groupId': 'OG001'}, {'value': '34.8', 'spread': '3.5', 'groupId': 'OG002'}]}]}, {'title': 'Social function of FSS: 1 month', 'categories': [{'measurements': [{'value': '42.8', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '42.5', 'spread': '3.3', 'groupId': 'OG001'}, {'value': '37.5', 'spread': '3.6', 'groupId': 'OG002'}]}]}, {'title': 'Social function of FSS: 3 months', 'categories': [{'measurements': [{'value': '46.4', 'spread': '3.9', 'groupId': 'OG000'}, {'value': '45.8', 'spread': '3.3', 'groupId': 'OG001'}, {'value': '40.0', 'spread': '3.5', 'groupId': 'OG002'}]}]}, {'title': 'Social function of FSS: 6 months', 'categories': [{'measurements': [{'value': '49.1', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '47.8', 'spread': '3.4', 'groupId': 'OG001'}, {'value': '42.3', 'spread': '3.9', 'groupId': 'OG002'}]}]}, {'title': 'Self care of CAS: Baseline', 'categories': [{'measurements': [{'value': '18.0', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '17.9', 'spread': '3.7', 'groupId': 'OG001'}, {'value': '15.3', 'spread': '3.2', 'groupId': 'OG002'}]}]}, {'title': 'Self care of CAS: 1 month', 'categories': [{'measurements': [{'value': '20.1', 'spread': '4.0', 'groupId': 'OG000'}, {'value': '21.1', 'spread': '3.8', 'groupId': 'OG001'}, {'value': '19.0', 'spread': '3.7', 'groupId': 'OG002'}]}]}, {'title': 'Self care of CAS: 3 months', 'categories': [{'measurements': [{'value': '27.0', 'spread': '4.3', 'groupId': 'OG000'}, {'value': '24.2', 'spread': '3.9', 'groupId': 'OG001'}, {'value': '21.5', 'spread': '3.7', 'groupId': 'OG002'}]}]}, {'title': 'Self care of CAS: 6 months', 'categories': [{'measurements': [{'value': '29.4', 'spread': '4.0', 'groupId': 'OG000'}, {'value': '26.0', 'spread': '4.1', 'groupId': 'OG001'}, {'value': '23.1', 'spread': '3.9', 'groupId': 'OG002'}]}]}, {'title': 'Mobility of CAS: Baseline', 'categories': [{'measurements': [{'value': '14.6', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '19.7', 'spread': '4.8', 'groupId': 'OG001'}, {'value': '13.5', 'spread': '4.0', 'groupId': 'OG002'}]}]}, {'title': 'Mobility of CAS: 1 month', 'categories': [{'measurements': [{'value': '19.6', 'spread': '4.5', 'groupId': 'OG000'}, {'value': '22.6', 'spread': '4.9', 'groupId': 'OG001'}, {'value': '15.6', 'spread': '4.2', 'groupId': 'OG002'}]}]}, {'title': 'Moblity of CAS: 3 months', 'categories': [{'measurements': [{'value': '22.5', 'spread': '5.1', 'groupId': 'OG000'}, {'value': '26.0', 'spread': '5.3', 'groupId': 'OG001'}, {'value': '19.3', 'spread': '4.5', 'groupId': 'OG002'}]}]}, {'title': 'Mobility of CAS: 6 months', 'categories': [{'measurements': [{'value': '24.9', 'spread': '5.5', 'groupId': 'OG000'}, {'value': '29.2', 'spread': '5.4', 'groupId': 'OG001'}, {'value': '24.0', 'spread': '4.8', 'groupId': 'OG002'}]}]}, {'title': 'Social function of CAS: Baseline', 'categories': [{'measurements': [{'value': '23.0', 'spread': '5.2', 'groupId': 'OG000'}, {'value': '24.7', 'spread': '3.9', 'groupId': 'OG001'}, {'value': '18.2', 'spread': '4.4', 'groupId': 'OG002'}]}]}, {'title': 'Social function of CAS: 1 month', 'categories': [{'measurements': [{'value': '28.5', 'spread': '5.6', 'groupId': 'OG000'}, {'value': '30.0', 'spread': '4.5', 'groupId': 'OG001'}, {'value': '21.1', 'spread': '4.8', 'groupId': 'OG002'}]}]}, {'title': 'Social function of CAS: 3 months', 'categories': [{'measurements': [{'value': '34.8', 'spread': '6.0', 'groupId': 'OG000'}, {'value': '34.2', 'spread': '4.8', 'groupId': 'OG001'}, {'value': '24.2', 'spread': '5.0', 'groupId': 'OG002'}]}]}, {'title': 'Social function of CAS: 6 months', 'categories': [{'measurements': [{'value': '38.4', 'spread': '6.2', 'groupId': 'OG000'}, {'value': '36.2', 'spread': '4.6', 'groupId': 'OG001'}, {'value': '27.6', 'spread': '5.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline -1 month - 3 months - 6 months', 'description': 'Pediatric Evaluation of Disability Inventory (PEDI) for assessing functional performance in daily activities in children (All values are adjusted and higher value means better functional performance, 0 - worst, 100 - best). We reported here 2 scales and 3 domains of each scale: a Functional Skill Scale (FSS) and a Caregiver Assistance Scale (CAS) which are divided respectively into 3 domains: self care, mobility, and social function. Categories of outcome table are each domain scores measured at each assessment time point.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat'}, {'type': 'PRIMARY', 'title': 'Changes in Standardized Gross Motor Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Umbilical Cord Blood & Erythropoietin & Rehabilitation', 'description': 'Allogeneic umbilical cord blood infusion (total nucleated cells \\> 3x10\\^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation'}, {'id': 'OG001', 'title': 'Erythropoietin & Rehabilitation', 'description': 'Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation'}, {'id': 'OG002', 'title': 'Only Rehabilitation', 'description': 'Active rehabilitation'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '36.0', 'spread': '4.7', 'groupId': 'OG000'}, {'value': '42.6', 'spread': '4.9', 'groupId': 'OG001'}, {'value': '36.8', 'spread': '4.5', 'groupId': 'OG002'}]}]}, {'title': '1 month - Baseline', 'categories': [{'measurements': [{'value': '3.7', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '4.3', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '4.6', 'spread': '0.6', 'groupId': 'OG002'}]}]}, {'title': '3 months - Baseline', 'categories': [{'measurements': [{'value': '6.5', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '6.4', 'spread': '0.7', 'groupId': 'OG002'}]}]}, {'title': '6 months - Baseline', 'categories': [{'measurements': [{'value': '9.1', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '9.0', 'spread': '1.1', 'groupId': 'OG001'}, {'value': '7.8', 'spread': '0.9', 'groupId': 'OG002'}]}]}, {'title': '3 months - 1 month', 'categories': [{'measurements': [{'value': '2.9', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '1.8', 'spread': '0.4', 'groupId': 'OG002'}]}]}, {'title': '6 months - 1 month', 'categories': [{'measurements': [{'value': '5.4', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '3.1', 'spread': '0.6', 'groupId': 'OG002'}]}]}, {'title': '6 months - 3 months', 'categories': [{'measurements': [{'value': '2.6', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '1.3', 'spread': '0.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'interaction of group and visit', 'ciPctValue': '95', 'paramValue': '0.90', 'groupDescription': 'In our analysis, the null hypothesis is that the effects of 3 experimental groups are same, and the alternative hypothesis is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.', 'statisticalMethod': 'Repeated Measure ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline - 1 month - 3 months - 6 months', 'description': 'GMFM (Gross Motor Function Measure) as a standardized measurement tool for assessing Gross Motor Function consisting of sub-scales; lying \\& rolling, sitting, crawling \\& kneeling, standing, walking, running \\& jumping (range: 0\\~100 , Higher value means better gross motor function). We reported changes of GMFM between each assessment time points. Categories of outcome table are baseline and values of just subtracting the latter raw scores from the former ones.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat', 'anticipatedPostingDate': '2011-09'}, {'type': 'SECONDARY', 'title': 'Changes in Functional Independence in Daily Activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Umbilical Cord Blood & Erythropoietin & Rehabilitation', 'description': 'Allogeneic umbilical cord blood infusion (total nucleated cells \\> 3x10\\^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation'}, {'id': 'OG001', 'title': 'Erythropoietin & Rehabilitation', 'description': 'Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation'}, {'id': 'OG002', 'title': 'Only Rehabilitation', 'description': 'Active rehabilitation'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '34.1', 'spread': '3.8', 'groupId': 'OG000'}, {'value': '36.6', 'spread': '3.7', 'groupId': 'OG001'}, {'value': '31.4', 'spread': '2.9', 'groupId': 'OG002'}]}]}, {'title': '1 month', 'categories': [{'measurements': [{'value': '35.6', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '37.5', 'spread': '3.8', 'groupId': 'OG001'}, {'value': '33.2', 'spread': '3.1', 'groupId': 'OG002'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '38.7', 'spread': '4.7', 'groupId': 'OG000'}, {'value': '38.5', 'spread': '4.1', 'groupId': 'OG001'}, {'value': '37.1', 'spread': '3.8', 'groupId': 'OG002'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '41.1', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '40.3', 'spread': '4.2', 'groupId': 'OG001'}, {'value': '37.7', 'spread': '4.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': "Wilks' Lambda (group*visit effect)", 'ciPctValue': '95', 'paramValue': '1.279', 'groupDescription': 'In our analysis, the null hypothesis is that the effects of 3 experimental groups are same, and the alternative hypothesis is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.', 'statisticalMethod': 'Repeated Measure ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline - 1 month - 3 months - 6 months', 'description': 'WeeFIM (Functional Independence Measure for Children) measures functional independence in daily activities. WeeFIM contains 18 items and each item is ranked from complete dependence (scored as 1) to complete independence (scored as 7). The range is from 18 to 126 and higher scores mean more independent performance in daily activities. Categories of outcome table are total WeeFIM scores measured at each assessment time point.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Changes in Muscle Strength', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Umbilical Cord Blood & Erythropoietin & Rehabilitation', 'description': 'Allogeneic umbilical cord blood infusion (total nucleated cells \\> 3x10\\^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation'}, {'id': 'OG001', 'title': 'Erythropoietin & Rehabilitation', 'description': 'Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation'}, {'id': 'OG002', 'title': 'Only Rehabilitation', 'description': 'Active rehabilitation'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '100.7', 'spread': '5.5', 'groupId': 'OG000'}, {'value': '104.8', 'spread': '4.4', 'groupId': 'OG001'}, {'value': '100.3', 'spread': '4.6', 'groupId': 'OG002'}]}]}, {'title': '1 month', 'categories': [{'measurements': [{'value': '105.0', 'spread': '4.9', 'groupId': 'OG000'}, {'value': '106.8', 'spread': '4.5', 'groupId': 'OG001'}, {'value': '101.8', 'spread': '4.6', 'groupId': 'OG002'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '107.8', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '107.7', 'spread': '4.5', 'groupId': 'OG001'}, {'value': '103.6', 'spread': '4.6', 'groupId': 'OG002'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '109.9', 'spread': '4.6', 'groupId': 'OG000'}, {'value': '109.3', 'spread': '4.5', 'groupId': 'OG001'}, {'value': '104.3', 'spread': '4.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': "Wilks' Lambda (group*visit effect)", 'ciPctValue': '95', 'paramValue': '0.996', 'groupDescription': 'In our analysis, the null hypothesis is that the effects of 3 experimental groups are same, and the alternative hypothesis is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.', 'statisticalMethod': 'Repeated Measure ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline - 1 month - 3 months - 6 months', 'description': 'Summation of MMT (manual muscle strength test score): summated scores of the manual muscle strength test (zero=0, trace=1, poor=2, fair=3, good=4, normal=5) for flexors, extensors, abductors, and adductors of bilateral shoulder and hip joints; flexors and extensors of bilateral elbow, wrist, and knee; dorsiflexors and plantar flexors of the ankles (range: 0 \\~ 160) Higher score means better muscle strength. Categories of outcome table are summation of MMT scores measured at each assessment time point.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Changes in Hand Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Umbilical Cord Blood & Erythropoietin & Rehabilitation', 'description': 'Allogeneic umbilical cord blood infusion (total nucleated cells \\> 3x10\\^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation'}, {'id': 'OG001', 'title': 'Erythropoietin & Rehabilitation', 'description': 'Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation'}, {'id': 'OG002', 'title': 'Only Rehabilitation', 'description': 'Active rehabilitation'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '36.0', 'spread': '6.4', 'groupId': 'OG000'}, {'value': '52.8', 'spread': '4.9', 'groupId': 'OG001'}, {'value': '43.0', 'spread': '5.5', 'groupId': 'OG002'}]}]}, {'title': '1 month - Baseline', 'categories': [{'measurements': [{'value': '5.0', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '1.7', 'groupId': 'OG001'}, {'value': '6.6', 'spread': '1.4', 'groupId': 'OG002'}]}]}, {'title': '3 months - Baseline', 'categories': [{'measurements': [{'value': '11.1', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '8.8', 'spread': '2.0', 'groupId': 'OG001'}, {'value': '10.5', 'spread': '1.8', 'groupId': 'OG002'}]}]}, {'title': '6 months - Baseline', 'categories': [{'measurements': [{'value': '13.9', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '10.7', 'spread': '2.2', 'groupId': 'OG001'}, {'value': '13.0', 'spread': '2.4', 'groupId': 'OG002'}]}]}, {'title': '3 months - 1 month', 'categories': [{'measurements': [{'value': '5.7', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '1.0', 'groupId': 'OG001'}, {'value': '3.5', 'spread': '1.7', 'groupId': 'OG002'}]}]}, {'title': '6 months - 1 month', 'categories': [{'measurements': [{'value': '8.4', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '1.3', 'groupId': 'OG001'}, {'value': '6.4', 'spread': '2.1', 'groupId': 'OG002'}]}]}, {'title': '6 months - 3 months', 'categories': [{'measurements': [{'value': '2.8', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '0.8', 'groupId': 'OG001'}, {'value': '3.1', 'spread': '1.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': "Wilks' Lambda (group*visit effect)", 'ciPctValue': '95', 'paramValue': '0.56', 'groupDescription': 'In our analysis, the null hypothesis is that the effects of 3 experimental groups are same, and the alternative hypothesis is that the therapeutic effect of combination intervention Group (Umbilical Cord Blood + Erythropoietin + Rehabilitation) is higher than that of either Erythropoietin + Rehabilitation or Rehabilitation Group. This is a pilot study and power calculation was not applicable. The sample size of each group is over 30 and is considered to follow approximately normal distribution.', 'statisticalMethod': 'Repeated Measure ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline - 1 month - 3 months - 6 months', 'description': 'QUEST (Quality of Upper Extremity Skills Test) as a standardized measurement tool for assessing hand function consisting of sub-scales; dissociated movement, grasps, weight bearing, and protective extension. These are standardized to range from zero (or below zero in grasp section) to 100 and higher values mean better hand function. We reported QUEST differences between each assessment times.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious Adverse Events as a Measure of Safety,Which Are Related to Umbilical Cord Blood, Erythropoietin, or Immunosuppressant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Umbilical Cord Blood & Erythropoietin & Rehabilitation', 'description': 'Allogeneic umbilical cord blood infusion (total nucleated cells \\> 3x10\\^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation'}, {'id': 'OG001', 'title': 'Erythropoietin & Rehabilitation', 'description': 'Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation'}, {'id': 'OG002', 'title': 'Only Rehabilitation', 'description': 'Active rehabilitation'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'statisticalComment': 'We compared the ratio of participants with a certain adverse event (AE) and without the AE between three groups using Fisher Exact test.'}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'The number of patients with serious adverse events within each group; Serious adverse events were defined as any event that resulted in death, was life-threatening, required hospitalization or prolonged the hospital stay, or was otherwise serious in the judgment of the investigator.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Umbilical Cord Blood & Erythropoietin & Rehabilitation', 'description': 'Allogeneic umbilical cord blood infusion (total nucleated cells \\> 3x10\\^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation'}, {'id': 'FG001', 'title': 'Erythropoietin & Rehabilitation', 'description': 'Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation'}, {'id': 'FG002', 'title': 'Only Rehabilitation', 'description': 'Active rehabilitation'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '36'}, {'groupId': 'FG002', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Enrollment Period: May 31, 2010 through April 9, 2011 All participants were recruited at CHA Bundang Medical Center.', 'preAssignmentDetails': 'We tried to recruit 106 subjects. Finally 105 patients were enrolled at the beginning of the overall study and none of the participants were washed out before assignment to groups.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '105', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Umbilical Cord Blood & Erythropoietin & Rehabilitation', 'description': 'Allogeneic umbilical cord blood infusion (total nucleated cells \\> 3x10\\^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation'}, {'id': 'BG001', 'title': 'Erythropoietin & Rehabilitation', 'description': 'Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation'}, {'id': 'BG002', 'title': 'Only Rehabilitation', 'description': 'Active rehabilitation'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '105', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.71', 'spread': '18.91', 'groupId': 'BG000'}, {'value': '50.05', 'spread': '24.45', 'groupId': 'BG001'}, {'value': '46.0', 'spread': '19.58', 'groupId': 'BG002'}, {'value': '47.30', 'spread': '21.07', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Korea, Republic of', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '105', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-06', 'studyFirstSubmitDate': '2010-08-29', 'resultsFirstSubmitDate': '2011-10-11', 'studyFirstSubmitQcDate': '2010-08-31', 'lastUpdatePostDateStruct': {'date': '2020-11-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-01-30', 'studyFirstPostDateStruct': {'date': '2010-09-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-03-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Motor Performance', 'timeFrame': 'Baseline -1 month - 3 months - 6 months', 'description': 'GMPM (Gross Motor Performance Measure) as a standardized measurement tool for assessing quality of movement regarding 3 properties of 5 ones; alignment, coordination, dissociated movement, stability, and weight shift (range: 0\\~100, Higher value means better motor quality). We reported changes of GMPM score between each assessment time points. Categories of outcome table are baseline and values of just subtracting the latter raw scores from the former ones.'}, {'measure': 'Changes in Standardized Gross Motor Function', 'timeFrame': 'Baseline - 1 month - 3 months - 6 months', 'description': 'GMFM (Gross Motor Function Measure) as a standardized measurement tool for assessing Gross Motor Function consisting of sub-scales; lying \\& rolling, sitting, crawling \\& kneeling, standing, walking, running \\& jumping (range: 0\\~100 , Higher value means better gross motor function). We reported changes of GMFM between each assessment time points. Categories of outcome table are baseline and values of just subtracting the latter raw scores from the former ones.'}], 'secondaryOutcomes': [{'measure': 'Changes in Cognitive Neurodevelopmental Outcome', 'timeFrame': 'Baseline -1 month - 3 months - 6 months', 'description': 'Korean version of Bayley Scale of Infant Development-II (K-BSID-II) Mental Scales (higher value means better mental function: 0 - worst, 178 - best). We reported changes of BSID-II Mental Scale raw score between each assessment time points. Categories of outcome data are values of subtracting the latter scores from the former ones.'}, {'measure': 'Changes in Motor Neurodevelopmental Outcome', 'timeFrame': 'Baseline - 1 month - 3 months - 6 months', 'description': 'Korean version of Bayley Scale of Infant Development-II (K-BSID-II) Motor Scales (higher value means better motor function: 0 - worst, 111 - best). We reported changes of BSID-II Motor Scale raw score between each assessment time points. Categories of outcome data are values of subtracting the latter scores from the former ones.'}, {'measure': 'Changes in Brain MRI', 'timeFrame': 'Baseline - 6 months', 'description': 'Changes on brain Diffusion Tensor Image (DTI); DTI provides quantitative information about the microscopic integrity of white matter. White matter normally possesses a high degree of diffusion anisotropy than gray matter. We can measure fractional anisotropy (FA) value in DTI imaging and it ranges from 0 to 1. Higher FA value of a certain region of interest means the area has more integrity of white matter.'}, {'measure': 'Comparison of Changes in Brain Glucose Metabolism Using by Brain 18F-FDG PET: Increased and Decreased Areas of Brain Glucose Metabolism', 'timeFrame': 'Baseline - 2 weeks', 'description': '18F-FDG PET imaging was performed twice prior to and then 2 weeks post-treatment. Ninety slices of each emission image were obtained, and all scans were reviewed by a nuclear physician. Spatial pre-processing and statistical analyses were performed using SPM8 implanted in Matlab to compare differences in regional brain glucose metabolism between groups and differences between pre- and post-therapy imaging data. We reported increased areas and decreased areas of glucose metabolism in three groups. We defined that "1" refers to INCREASED areas, "-1", DECREASED areas and "0", just NO CHANGE.'}, {'measure': 'Changes in Functional Performance in Daily Activities', 'timeFrame': 'Baseline -1 month - 3 months - 6 months', 'description': 'Pediatric Evaluation of Disability Inventory (PEDI) for assessing functional performance in daily activities in children (All values are adjusted and higher value means better functional performance, 0 - worst, 100 - best). We reported here 2 scales and 3 domains of each scale: a Functional Skill Scale (FSS) and a Caregiver Assistance Scale (CAS) which are divided respectively into 3 domains: self care, mobility, and social function. Categories of outcome table are each domain scores measured at each assessment time point.'}, {'measure': 'Changes in Functional Independence in Daily Activities', 'timeFrame': 'Baseline - 1 month - 3 months - 6 months', 'description': 'WeeFIM (Functional Independence Measure for Children) measures functional independence in daily activities. WeeFIM contains 18 items and each item is ranked from complete dependence (scored as 1) to complete independence (scored as 7). The range is from 18 to 126 and higher scores mean more independent performance in daily activities. Categories of outcome table are total WeeFIM scores measured at each assessment time point.'}, {'measure': 'Changes in Muscle Strength', 'timeFrame': 'Baseline - 1 month - 3 months - 6 months', 'description': 'Summation of MMT (manual muscle strength test score): summated scores of the manual muscle strength test (zero=0, trace=1, poor=2, fair=3, good=4, normal=5) for flexors, extensors, abductors, and adductors of bilateral shoulder and hip joints; flexors and extensors of bilateral elbow, wrist, and knee; dorsiflexors and plantar flexors of the ankles (range: 0 \\~ 160) Higher score means better muscle strength. Categories of outcome table are summation of MMT scores measured at each assessment time point.'}, {'measure': 'Changes in Hand Function', 'timeFrame': 'Baseline - 1 month - 3 months - 6 months', 'description': 'QUEST (Quality of Upper Extremity Skills Test) as a standardized measurement tool for assessing hand function consisting of sub-scales; dissociated movement, grasps, weight bearing, and protective extension. These are standardized to range from zero (or below zero in grasp section) to 100 and higher values mean better hand function. We reported QUEST differences between each assessment times.'}, {'measure': 'Number of Participants With Serious Adverse Events as a Measure of Safety,Which Are Related to Umbilical Cord Blood, Erythropoietin, or Immunosuppressant', 'timeFrame': '6 months', 'description': 'The number of patients with serious adverse events within each group; Serious adverse events were defined as any event that resulted in death, was life-threatening, required hospitalization or prolonged the hospital stay, or was otherwise serious in the judgment of the investigator.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['umbilical cord blood', 'stem cell', 'cerebral palsy'], 'conditions': ['Cerebral Palsy']}, 'descriptionModule': {'briefSummary': 'This randomized control study is aimed to determine efficacy of umbilical cord blood and erythropoietin combination therapy for children with cerebral palsy.', 'detailedDescription': "Cerebral palsy is a disorder of movement and posture that result from a nonprogressive lesion or injury of the immature brain. It is a leading cause of childhood onset disability through one's life. Umbilical cord blood(UCB) is suggested as therapeutic method for cerebral palsy which resulted from animal studies. Stem cells included in UCB is expected to exert therapeutic efficacy for functional recovery.\n\nIt is also suggested that erythropoietin is useful to repair neurological injury in brain. The main mechanism of erythropoietin is supposed to be neuroprotection and neurogenesis which would reinforce the effect of stem cell as well.\n\nAlthough autologous umbilical cord would be safe, the children who have problems at birth seldom have autologous umbilical cord blood. Allogenic umbilical cord blood might be useful for these children if its effect is approved."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '10 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Known cerebral palsy\n* Willing to comply with all study procedure\n\nExclusion Criteria:\n\n* High risk of pneumonia or renal function deterioration after using of immunosuppressant\n* Presence of known genetic disease\n* Possibility of drug hypersensitivity which is related to this study remedy\n* History of previous cell therapy\n* Poor cooperation of guardian,including inactive attitude for rehabilitation\n* Intractable seizure disorder\n* Autism'}, 'identificationModule': {'nctId': 'NCT01193660', 'briefTitle': 'Allogenic Umbilical Cord Blood and Erythropoietin Combination Therapy for Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'Sung Kwang Medical Foundation'}, 'officialTitle': 'Double-blind Randomized Controlled Trial to Evaluate the Efficacy and Safety of a Combination Therapy of Allogenic Umbilical Cord Blood and Erythropoietin for Children With Cerebral Palsy', 'orgStudyIdInfo': {'id': 'RCTUBSC'}, 'secondaryIdInfos': [{'id': 'PBC09-095', 'type': 'OTHER', 'domain': 'IRB of CHA Bundang Medical Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Umbilical Cord Blood & Erythropoietin & Rehabilitation', 'description': 'Allogenic umbilical cord blood infusion, erythropoietin injection \\& active rehabilitation', 'interventionNames': ['Biological: Umbilical Cord Blood Infusion', 'Drug: Erythropoietin Injection', 'Other: Active Rehabilitation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Erythropoietin & Rehabilitation', 'description': 'Erythropoietin injection, active rehabilitation', 'interventionNames': ['Drug: Erythropoietin Injection', 'Other: Active Rehabilitation', 'Other: Placebo Umbilical Cord Blood']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Only Rehabilitation', 'description': 'Active rehabilitation', 'interventionNames': ['Other: Active Rehabilitation', 'Other: Placebo Umbilical Cord Blood', 'Other: Placebo Erythropoietin']}], 'interventions': [{'name': 'Umbilical Cord Blood Infusion', 'type': 'BIOLOGICAL', 'otherNames': ['Donated Umbilical Cord Blood Units from Affiliated Cord Blood Bank'], 'description': 'The subjects will be undertaken allogeneic umbilical cord blood infusion (total nucleated cells \\> 3x10\\^7/kg) intravenously under non-myeloablative immunosuppression (maintaining blood level of cyclosporine as 100-200ng/mL for 1 month).', 'armGroupLabels': ['Umbilical Cord Blood & Erythropoietin & Rehabilitation']}, {'name': 'Erythropoietin Injection', 'type': 'DRUG', 'otherNames': ['Brand name of Erythropoietin: Espogen (made by LG Life Science)'], 'description': 'Erythropoietin will be given as the schedule of twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times.', 'armGroupLabels': ['Erythropoietin & Rehabilitation', 'Umbilical Cord Blood & Erythropoietin & Rehabilitation']}, {'name': 'Active Rehabilitation', 'type': 'OTHER', 'description': 'All subjects should participate in active rehabilitation. They received two physical and occupational therapy sessions per day. Post discharge, each participant continued to receive rehabilitation therapy at least 3 days per week for additional 5 months.', 'armGroupLabels': ['Erythropoietin & Rehabilitation', 'Only Rehabilitation', 'Umbilical Cord Blood & Erythropoietin & Rehabilitation']}, {'name': 'Placebo Umbilical Cord Blood', 'type': 'OTHER', 'otherNames': ['Placebo Umbilical Cord Blood that resembles cord blood in appearance was designed', ": 1.5 to 3 ml of the subject's own blood was collected and mixed with 15 to 20 ml of albumin."], 'description': 'Placebo Umbilical Cord Blood will be given except the Experimental arm. Placebo Umbilical Cord Blood was made using peripheral blood. Participants and Investigators maintained as blind.', 'armGroupLabels': ['Erythropoietin & Rehabilitation', 'Only Rehabilitation']}, {'name': 'Placebo Erythropoietin', 'type': 'OTHER', 'description': 'Placebo Erythropoietin containing Normal Saline', 'armGroupLabels': ['Only Rehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'CHA Bundang Medical Center', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'overallOfficials': [{'name': 'Minyoung Kim, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'CHA University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sung Kwang Medical Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}