Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2026-01-05 @ 5:31 PM
Study NCT ID:
NCT02165904
Status:
COMPLETED
Last Update Posted:
2019-07-19
First Post:
2014-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Subarachnoid Administrations of Adults Autologous Mesenchymal Stromal Cells in SCI
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jesus.vaquero@salud.madrid.org', 'phone': '91 191 7760', 'title': 'Dr. Vaquero Crespo', 'organization': 'Hospital Universitario Puerta de Hierro Majadahonda, Madrid'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '2 years', 'eventGroups': [{'id': 'EG000', 'title': 'Autologous Mesenchymal Bone Marrow Cell', 'description': 'Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells expanded in vitro. Administrated by subarachnoid injection by lumbar puncture of 30x10\\^6 cells, and repeated at months 4, 7 and 10, reaching a total administration of 120x10\\^6 cells for each patient', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 9, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Hypertension', 'notes': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Local pain', 'notes': 'Local pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Leg pain', 'notes': 'Leg pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Urinary tract infection', 'notes': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Headache', 'notes': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Hyperthermia', 'notes': 'Hyperthermia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Wound', 'notes': 'Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Infected pressure ulcer', 'notes': 'Infected pressure ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Arthralgia', 'notes': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Syncope', 'notes': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Pain in coccyx', 'notes': 'Pain in coccyx', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Neck pain', 'notes': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Back pain', 'notes': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Nasopharingytis', 'notes': 'Nasopharingytis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Bronchitis', 'notes': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}, {'term': 'Urinary retention', 'notes': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.1)'}], 'seriousEvents': [{'term': 'Bronchitis', 'notes': 'Acute Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Efficacy-Sensivity Improvement Using the ASIA Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Autologous Mesenchymal Bone Marrow Cell', 'description': 'Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells expanded in vitro. Administrated by subarachnoid injection by lumbar puncture of 30x10\\^6 cells, and repeated at months 4, 7 and 10, reaching a total administration of 120x10\\^6 cells for each patient'}], 'classes': [{'title': 'before surgery', 'categories': [{'measurements': [{'value': '188.2', 'spread': '60', 'groupId': 'OG000'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '202.2', 'spread': '63.7', 'groupId': 'OG000'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '218.4', 'spread': '57.5', 'groupId': 'OG000'}]}]}, {'title': '9 months', 'categories': [{'measurements': [{'value': '228.9', 'spread': '51.84', 'groupId': 'OG000'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '235.5', 'spread': '49.35', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'measure before treatment (baseline visit), 3, 6, 9 and 12 months after surgery', 'description': 'Sensitivity improvement was measured using the ASIA (American Spinal Injury Association) scale to measure the Surface sensitivity (LTS), pain sensitivity (PPS), and the degree of motor function in key muscles (MS). The sum of MS, LTS, and PPS configure total ASIA score. A minimum possible score is 0 points. A maximum possible score is 224 points for a patient with normal sensation. ASIA score was obtained before surgery, and 3, 6, 9 and 12 months after surgery. Mean and standard deviation for the 10 patients were obtained at all the time points and statistically analyzed.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Efficacy- Changes in Functional Independence Measure Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Autologous Mesenchymal Bone Marrow Cell', 'description': 'Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells expanded in vitro. Administrated by subarachnoid injection by lumbar puncture of 30x10\\^6 cells, and repeated at months 4, 7 and 10, reaching a total administration of 120x10\\^6 cells for each patient'}], 'classes': [{'title': 'before surgery', 'categories': [{'measurements': [{'value': '95.7', 'spread': '33.9', 'groupId': 'OG000'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '95.7', 'spread': '33.9', 'groupId': 'OG000'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '95.7', 'spread': '33.9', 'groupId': 'OG000'}]}]}, {'title': '9 months', 'categories': [{'measurements': [{'value': '96.10', 'spread': '33.42', 'groupId': 'OG000'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '98.6', 'spread': '32.05', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery', 'description': '\\- Changes in Functional Independence Measure scale (NIF scale), score at the beginning, through and the end of the treatment.\n\nRanges score: 18 to 126. Being 18 total patient dependency and 126 total patient independence.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Efficacy-Change in Barthel Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Autologous Mesenchymal Bone Marrow Cell', 'description': 'Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells expanded in vitro. Administrated by subarachnoid injection by lumbar puncture of 30x10\\^6 cells, and repeated at months 4, 7 and 10, reaching a total administration of 120x10\\^6 cells for each patient'}], 'classes': [{'title': 'before surgery', 'categories': [{'measurements': [{'value': '58', 'spread': '36.07', 'groupId': 'OG000'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '58', 'spread': '36.07', 'groupId': 'OG000'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '58', 'spread': '36.07', 'groupId': 'OG000'}]}]}, {'title': '9 months', 'categories': [{'measurements': [{'value': '58', 'spread': '36.07', 'groupId': 'OG000'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '65', 'spread': '35.59', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery', 'description': '\\- Changes in Barthel score at the beginning, through and the end of the treatment.\n\nRanges score: 0 to 100. Being 0 total patient dependency and 100 total patient independence.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Efficacy-IANC-SCIFRS Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Autologous Mesenchymal Bone Marrow Cell', 'description': 'Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells expanded in vitro. Administrated by subarachnoid injection by lumbar puncture of 30x10\\^6 cells, and repeated at months 4, 7 and 10, reaching a total administration of 120x10\\^6 cells for each patient'}], 'classes': [{'title': 'before surgery', 'categories': [{'measurements': [{'value': '29.10', 'spread': '9.96', 'groupId': 'OG000'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '31.5', 'spread': '8.89', 'groupId': 'OG000'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '33.90', 'spread': '9.73', 'groupId': 'OG000'}]}]}, {'title': '9 months', 'categories': [{'measurements': [{'value': '35.9', 'spread': '9.01', 'groupId': 'OG000'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '36.9', 'spread': '8.21', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Changes in IANC-SCIFRS scale before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period)', 'description': '-Changes in IANC-SCIFRS scale\n\nRanges score: 0 to 48. Being 0 severe degree of disability and 48 normal value.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Efficacy-Changes in PENN Score.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Autologous Mesenchymal Bone Marrow Cell', 'description': 'Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells expanded in vitro. Administrated by subarachnoid injection by lumbar puncture of 30x10\\^6 cells, and repeated at months 4, 7 and 10, reaching a total administration of 120x10\\^6 cells for each patient'}], 'classes': [{'title': 'before surgery', 'categories': [{'measurements': [{'value': '1.20', 'spread': '1.14', 'groupId': 'OG000'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '1.10', 'spread': '1.10', 'groupId': 'OG000'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '0.90', 'spread': '0.88', 'groupId': 'OG000'}]}]}, {'title': '9 months', 'categories': [{'measurements': [{'value': '0.90', 'spread': '0.88', 'groupId': 'OG000'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '0.90', 'spread': '0.88', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery', 'description': '\\- Changes in PENN score at the beginning, through and the end of the treatment\n\nRanges score: 0 to 4. Being 0 absence of spasms and 4 frequency greater than 10 spasms per hour.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Changes in ASHWORTH Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Autologous Mesenchymal Bone Marrow Cell', 'description': 'Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells expanded in vitro. Administrated by subarachnoid injection by lumbar puncture of 30x10\\^6 cells, and repeated at months 4, 7 and 10, reaching a total administration of 120x10\\^6 cells for each patient'}], 'classes': [{'title': 'before surgery', 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.81', 'groupId': 'OG000'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.81', 'groupId': 'OG000'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.81', 'groupId': 'OG000'}]}]}, {'title': '9 months', 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.81', 'groupId': 'OG000'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '1.10', 'spread': '0.99', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery', 'description': '\\- Changes in ASHWORTH score at the beginning, through and the end of the treatment\n\nRanges score: 0 to 4. Being 0 when there isn´t increase in muscle tone when stretching, and 4 when there is rigid affected follow-up in flexion or extension', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Efficacy-Changes in EVA Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Autologous Mesenchymal Bone Marrow Cell', 'description': 'Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells expanded in vitro. Administrated by subarachnoid injection by lumbar puncture of 30x10\\^6 cells, and repeated at months 4, 7 and 10, reaching a total administration of 120x10\\^6 cells for each patient'}], 'classes': [{'title': 'before surgery', 'categories': [{'measurements': [{'value': '1.70', 'spread': '3.13', 'groupId': 'OG000'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '0.70', 'spread': '1.16', 'groupId': 'OG000'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '0.60', 'spread': '0.97', 'groupId': 'OG000'}]}]}, {'title': '9 months', 'categories': [{'measurements': [{'value': '0.40', 'spread': '0.84', 'groupId': 'OG000'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '0.40', 'spread': '0.84', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery', 'description': '• Changes in EVA score at the beginning, through and the end of the treatment\n\nRanges score: 0 to 10. Being 0 absence of pain and 10 the worst pain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Efficacy- Changes in Geffner Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Autologous Mesenchymal Bone Marrow Cell', 'description': 'Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells expanded in vitro. Administrated by subarachnoid injection by lumbar puncture of 30x10\\^6 cells, and repeated at months 4, 7 and 10, reaching a total administration of 120x10\\^6 cells for each patient'}], 'classes': [{'title': 'before surgery', 'categories': [{'measurements': [{'value': '3.30', 'spread': '1.34', 'groupId': 'OG000'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '3.60', 'spread': '1.26', 'groupId': 'OG000'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '3.80', 'spread': '1.14', 'groupId': 'OG000'}]}]}, {'title': '9 months', 'categories': [{'measurements': [{'value': '3.90', 'spread': '1.10', 'groupId': 'OG000'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '4.20', 'spread': '1.23', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Changes in Geffner scale before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period)', 'description': 'changes in Geffner score before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period)\n\nRanges score: 0 to 6. Being 0 absence of bladder control and 6 total control of bladder', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Efficacy- Changes in NBD Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Autologous Mesenchymal Bone Marrow Cell', 'description': 'Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells expanded in vitro. Administrated by subarachnoid injection by lumbar puncture of 30x10\\^6 cells, and repeated at months 4, 7 and 10, reaching a total administration of 120x10\\^6 cells for each patient'}], 'classes': [{'title': 'before surgery', 'categories': [{'measurements': [{'value': '10.60', 'spread': '6.64', 'groupId': 'OG000'}]}]}, {'title': '3 months', 'categories': [{'measurements': [{'value': '6.10', 'spread': '4.15', 'groupId': 'OG000'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '5.70', 'spread': '4.35', 'groupId': 'OG000'}]}]}, {'title': '9 months', 'categories': [{'measurements': [{'value': '4.40', 'spread': '3.86', 'groupId': 'OG000'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '4.20', 'spread': '3.88', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery', 'description': 'changes in NBD score before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period)\n\nRanges score: 0 to 47. 0-6 is very minor dysfunction. 7-9 is minor dysfunction. 10-13 is moderate dysfunction; and 14 or more is severe dysfunction.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Efficacy-Changes in the Neurophysiological Parameters (SSEPs, Somatosensory Evoked Potentials)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Autologous Mesenchymal Bone Marrow Cell', 'description': 'Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells expanded in vitro. Administrated by subarachnoid injection by lumbar puncture of 30x10\\^6 cells, and repeated at months 4, 7 and 10, reaching a total administration of 120x10\\^6 cells for each patient'}], 'classes': [{'title': '6 months', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Efficacy-measure before treatment (baseline visit), 6, and 12 months after surgery', 'description': 'Changes in the neurophysiological parameters (SSEPs, somatosensory evoked potentials) measured as the number of patients that improved along the study.', 'unitOfMeasure': 'number of patients improved in SSEPs', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Efficacy-Urodynammic in Terms of Detrusor Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Autologous Mesenchymal Bone Marrow Cell', 'description': 'Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells expanded in vitro. Administrated by subarachnoid injection by lumbar puncture of 30x10\\^6 cells, and repeated at months 4, 7 and 10, reaching a total administration of 120x10\\^6 cells for each patient'}], 'classes': [{'title': 'before surgery', 'categories': [{'measurements': [{'value': '68.6', 'spread': '20.08', 'groupId': 'OG000'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '53.8', 'spread': '20.8', 'groupId': 'OG000'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '51.5', 'spread': '37.22', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Urodynamic studies before surgery, and at 6 and 12 months after surgery (follow-up', 'description': 'Urodynamic studies in terms of detrusor pressure (decrease on detrusor pressure is considered a clinical improvement)', 'unitOfMeasure': 'cm/H2O', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Efficacy-Urodynamic Studies Bladder Compliance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Autologous Mesenchymal Bone Marrow Cell', 'description': 'Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells expanded in vitro. Administrated by subarachnoid injection by lumbar puncture of 30x10\\^6 cells, and repeated at months 4, 7 and 10, reaching a total administration of 120x10\\^6 cells for each patient'}], 'classes': [{'title': 'before surgery', 'categories': [{'measurements': [{'value': '3.88', 'spread': '3.24', 'groupId': 'OG000'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '6.14', 'spread': '3.36', 'groupId': 'OG000'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '8.28', 'spread': '6.41', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'measure before treatment (baseline visit), 6 and 12 months after surgery', 'description': 'Urodynamic studies in terms of Bladder compliance. Bladder compliance is the result of a mathematical calculation of volume responsible for 1 cm H2O pressure rise measured during a cystometric filling\n\n. It gives an indication on how the different mechanisms in the bladder wall react on stretching.\n\nIt is obvious that compliance figures can vary widely in groups which makes it difficult to define limits of normality.', 'unitOfMeasure': 'mL/cm H2O', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Efficacy-Urodynamic Studies Maximum Cystometric Capacity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Autologous Mesenchymal Bone Marrow Cell', 'description': 'Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells expanded in vitro. Administrated by subarachnoid injection by lumbar puncture of 30x10\\^6 cells, and repeated at months 4, 7 and 10, reaching a total administration of 120x10\\^6 cells for each patient'}], 'classes': [{'title': 'before surgery', 'categories': [{'measurements': [{'value': '234.9', 'spread': '156.26', 'groupId': 'OG000'}]}]}, {'title': '6 months', 'categories': [{'measurements': [{'value': '292.4', 'spread': '110.93', 'groupId': 'OG000'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '292.6', 'spread': '183.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Urodynamic studies before surgery, and at 6 and 12 months after surgery (follow-up', 'description': 'Urodynamic studies in terms of Maximum cystometric capacity', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Efficacy-modification of Magnetic Resonance Imaging (MRI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Autologous Mesenchymal Bone Marrow Cell', 'description': 'Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells expanded in vitro. Administrated by subarachnoid injection by lumbar puncture of 30x10\\^6 cells, and repeated at months 4, 7 and 10, reaching a total administration of 120x10\\^6 cells for each patient'}], 'classes': [{'title': 'baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '12 months', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'before (baseline visit) and at 12 months', 'description': 'Number of patients with changes in morphology of injury compared with basal images', 'unitOfMeasure': 'number of patients', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Adverse Events .', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Autologous Mesenchymal Bone Marrow Cell', 'description': 'Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells expanded in vitro. Administrated by subarachnoid injection by lumbar puncture of 30x10\\^6 cells, and repeated at months 4, 7 and 10, reaching a total administration of 120x10\\^6 cells for each patient'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 12 months', 'description': '\\- The safety will be valued with number of adverse events related with administration of subarachnoid autologous Bone Marrow Expanded Mesenchymal Cells in Incomplete Spinal Cord Injury (SCI).', 'unitOfMeasure': 'Adverse events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Efficacy- Expression of Neurotrophins in CSF (CerebroSpinal Fluid) Samples', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Autologous Mesenchymal Bone Marrow Cell', 'description': 'Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells expanded in vitro. Administrated by subarachnoid injection by lumbar puncture of 30x10\\^6 cells, and repeated at months 4, 7 and 10, reaching a total administration of 120x10\\^6 cells for each patient'}], 'classes': [{'title': 'BDNF before administration', 'categories': [{'measurements': [{'value': '19.14', 'spread': '4.58', 'groupId': 'OG000'}]}]}, {'title': 'BDNF in month 10 after administration', 'categories': [{'measurements': [{'value': '33.82', 'spread': '49.65', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Basal and 10 months after the administration', 'description': 'Changes in expression of neurotrophins in CSF (CerebroSpinal Fluid) samples obtained previously to first administration of cell therapy, and previously to the last administration, at month 10, in order to study the variability in the expression of neurotrophins along time. The mean+SD (standard deviation) at each time point was obtained. The tested neurotrophins were: BDNF.', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Autologous Mesenchymal Bone Marrow Cell', 'description': 'Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells expanded in vitro. Administrated by subarachnoid injection by lumbar puncture of 30x10\\^6 cells, and repeated at months 4, 7 and 10, reaching a total administration of 120x10\\^6 cells for each patient'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Autologous Mesenchymal Bone Marrow Cell', 'description': 'Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells expanded in vitro. Administrated by subarachnoid injection by lumbar puncture of 30x10\\^6 cells, and repeated at months 4, 7 and 10, reaching a total administration of 120x10\\^6 cells for each patient'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.2', 'spread': '9.30', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Spain', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-14', 'studyFirstSubmitDate': '2014-05-06', 'resultsFirstSubmitDate': '2018-09-03', 'studyFirstSubmitQcDate': '2014-06-12', 'lastUpdatePostDateStruct': {'date': '2019-07-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-05-14', 'studyFirstPostDateStruct': {'date': '2014-06-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy-Sensivity Improvement Using the ASIA Score', 'timeFrame': 'measure before treatment (baseline visit), 3, 6, 9 and 12 months after surgery', 'description': 'Sensitivity improvement was measured using the ASIA (American Spinal Injury Association) scale to measure the Surface sensitivity (LTS), pain sensitivity (PPS), and the degree of motor function in key muscles (MS). The sum of MS, LTS, and PPS configure total ASIA score. A minimum possible score is 0 points. A maximum possible score is 224 points for a patient with normal sensation. ASIA score was obtained before surgery, and 3, 6, 9 and 12 months after surgery. Mean and standard deviation for the 10 patients were obtained at all the time points and statistically analyzed.'}, {'measure': 'Efficacy- Changes in Functional Independence Measure Scale', 'timeFrame': 'measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery', 'description': '\\- Changes in Functional Independence Measure scale (NIF scale), score at the beginning, through and the end of the treatment.\n\nRanges score: 18 to 126. Being 18 total patient dependency and 126 total patient independence.'}, {'measure': 'Efficacy-Change in Barthel Score', 'timeFrame': 'measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery', 'description': '\\- Changes in Barthel score at the beginning, through and the end of the treatment.\n\nRanges score: 0 to 100. Being 0 total patient dependency and 100 total patient independence.'}, {'measure': 'Efficacy-IANC-SCIFRS Scale', 'timeFrame': 'Changes in IANC-SCIFRS scale before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period)', 'description': '-Changes in IANC-SCIFRS scale\n\nRanges score: 0 to 48. Being 0 severe degree of disability and 48 normal value.'}, {'measure': 'Efficacy-Changes in PENN Score.', 'timeFrame': 'measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery', 'description': '\\- Changes in PENN score at the beginning, through and the end of the treatment\n\nRanges score: 0 to 4. Being 0 absence of spasms and 4 frequency greater than 10 spasms per hour.'}, {'measure': 'Changes in ASHWORTH Score', 'timeFrame': 'measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery', 'description': '\\- Changes in ASHWORTH score at the beginning, through and the end of the treatment\n\nRanges score: 0 to 4. Being 0 when there isn´t increase in muscle tone when stretching, and 4 when there is rigid affected follow-up in flexion or extension'}, {'measure': 'Efficacy-Changes in EVA Score', 'timeFrame': 'measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery', 'description': '• Changes in EVA score at the beginning, through and the end of the treatment\n\nRanges score: 0 to 10. Being 0 absence of pain and 10 the worst pain.'}, {'measure': 'Efficacy- Changes in Geffner Score', 'timeFrame': 'Changes in Geffner scale before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period)', 'description': 'changes in Geffner score before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period)\n\nRanges score: 0 to 6. Being 0 absence of bladder control and 6 total control of bladder'}, {'measure': 'Efficacy- Changes in NBD Score', 'timeFrame': 'measure before treatment (baseline visit), 3, 6,9 and 12 months after surgery', 'description': 'changes in NBD score before surgery (baseline visit) and 3, 6, 9, 12 months after surgery (follow-up period)\n\nRanges score: 0 to 47. 0-6 is very minor dysfunction. 7-9 is minor dysfunction. 10-13 is moderate dysfunction; and 14 or more is severe dysfunction.'}, {'measure': 'Efficacy-Changes in the Neurophysiological Parameters (SSEPs, Somatosensory Evoked Potentials)', 'timeFrame': 'Efficacy-measure before treatment (baseline visit), 6, and 12 months after surgery', 'description': 'Changes in the neurophysiological parameters (SSEPs, somatosensory evoked potentials) measured as the number of patients that improved along the study.'}, {'measure': 'Efficacy-Urodynammic in Terms of Detrusor Pressure', 'timeFrame': 'Urodynamic studies before surgery, and at 6 and 12 months after surgery (follow-up', 'description': 'Urodynamic studies in terms of detrusor pressure (decrease on detrusor pressure is considered a clinical improvement)'}, {'measure': 'Efficacy-Urodynamic Studies Bladder Compliance', 'timeFrame': 'measure before treatment (baseline visit), 6 and 12 months after surgery', 'description': 'Urodynamic studies in terms of Bladder compliance. Bladder compliance is the result of a mathematical calculation of volume responsible for 1 cm H2O pressure rise measured during a cystometric filling\n\n. It gives an indication on how the different mechanisms in the bladder wall react on stretching.\n\nIt is obvious that compliance figures can vary widely in groups which makes it difficult to define limits of normality.'}, {'measure': 'Efficacy-Urodynamic Studies Maximum Cystometric Capacity', 'timeFrame': 'Urodynamic studies before surgery, and at 6 and 12 months after surgery (follow-up', 'description': 'Urodynamic studies in terms of Maximum cystometric capacity'}, {'measure': 'Efficacy-modification of Magnetic Resonance Imaging (MRI)', 'timeFrame': 'before (baseline visit) and at 12 months', 'description': 'Number of patients with changes in morphology of injury compared with basal images'}], 'secondaryOutcomes': [{'measure': 'Number of Adverse Events .', 'timeFrame': 'Up to 12 months', 'description': '\\- The safety will be valued with number of adverse events related with administration of subarachnoid autologous Bone Marrow Expanded Mesenchymal Cells in Incomplete Spinal Cord Injury (SCI).'}, {'measure': 'Efficacy- Expression of Neurotrophins in CSF (CerebroSpinal Fluid) Samples', 'timeFrame': 'Basal and 10 months after the administration', 'description': 'Changes in expression of neurotrophins in CSF (CerebroSpinal Fluid) samples obtained previously to first administration of cell therapy, and previously to the last administration, at month 10, in order to study the variability in the expression of neurotrophins along time. The mean+SD (standard deviation) at each time point was obtained. The tested neurotrophins were: BDNF.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Analyze clinical efficacy of subarachnoid administration of', 'autologous BMSC expanded "in vitro"'], 'conditions': ['Spinal Cord Injury']}, 'referencesModule': {'references': [{'pmid': '21163325', 'type': 'BACKGROUND', 'citation': 'Vaquero J, Zurita M. Functional recovery after severe CNS trauma: current perspectives for cell therapy with bone marrow stromal cells. Prog Neurobiol. 2011 Mar;93(3):341-9. doi: 10.1016/j.pneurobio.2010.12.002. Epub 2010 Dec 14.'}, {'pmid': '21208021', 'type': 'BACKGROUND', 'citation': 'Otero L, Zurita M, Bonilla C, Aguayo C, Vela A, Rico MA, Vaquero J. Late transplantation of allogeneic bone marrow stromal cells improves neurologic deficits subsequent to intracerebral hemorrhage. Cytotherapy. 2011 May;13(5):562-71. doi: 10.3109/14653249.2010.544720. Epub 2011 Jan 5.'}]}, 'descriptionModule': {'briefSummary': 'The study goes on 24 months, with recruiting, treatment and follow period for all patients. The first day for each patient will be the first cellular administration. 3 doses will be administrated every 3 months from first dose.\n\nWhen the clinical trial finishes, it will be done a completed check of all obtained parameters.', 'detailedDescription': 'It is a clinical trial phase I, single center, non-randomized, uncontrolled, open prospective follow-up of a cohort of patients with chronic spinal cord injury (SCI) .10 patients will be included with this injury.\n\nPrimary objective: Analyze the possible clinical efficacy of administration of main adult mesenchymal autologous cells expanded "in vitro" in patients with incomplete and chronically established SCI.\n\nSecondary objectives: Confirm the safety of treatment, and study possible changes in the cerebrospinal fluid (CSF) levels (Brain-derived neurotrophic factor (BDNF), glial cell line-derived neurotrophic factor (GDNF), nerve growth factor (NGF), ciliary neurotrophic factor (CNTF), Nerve Growth Factor 3 and 4(NT3 and NT4) after subarachnoid administration of BMMC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Incomplete SCI\n2. Neurological deficit clinically stable at least 12 months prior to treatment, and with a minimum of one-year evolution after SCI.\n3. Neurophysiological confirmation of incomplete SCI.\n4. The MRI study that morphologically evaluate the SCI.\n5. Age between 18 and 70 years\n6. Thread Men and women will compromise to use anticonceptive issues from first cell´s extraction to 6 months after last cell´s administration.\n7. Ability to attend clinical follow-up and perform physical therapy through the treatment period.\n8. Written and signed informed consent, according to the local regulation.\n9. Hematologic and creatinin parameters, SGOT and SGPT, within the normal range, according to laboratory standards considering that small variations could be accepted based on clinical study team criteria.\n\nExclusion Criteria:\n\n1. A classification in ASIA and FRANKEL clinical scales to evaluate the SCI.\n2. Neurophysiological records that confirm the complete SCI.\n3. Age below 18 years or above 70.\n4. Pregnancy or lactation.\n5. Malignancy disease diagnosed or treated within the last 5 years.\n6. Patients with systemic disease that represents and additional risk to treatment.\n7. Patients with uncertain commitment to follow the physical therapy and clinical visits as well as patient with a negative input in the previous phycological assessment.\n8. Inability to assess the SCI features through MRI either noise due to spinal stabilization systems or any other cause.\n9. Patients currently under hematopoietic growth factors treatment or who required or maintained anticoagulation.\n10. Neurodegenerative disease additional.\n11. History of substance abuse, psychiatric disease or allergy to the protein products used in the process of cell expansion.\n12. Positive serology for HIV and syphilis.\n13. Active Hepatitis B or Hepatitis C.\n14. With other reason that would consider the patient ineligible for cell therapy according to the investigators judgment.'}, 'identificationModule': {'nctId': 'NCT02165904', 'briefTitle': 'Subarachnoid Administrations of Adults Autologous Mesenchymal Stromal Cells in SCI', 'organization': {'class': 'OTHER', 'fullName': 'Puerta de Hierro University Hospital'}, 'officialTitle': 'Subarachnoid Administrations of Adults Autologous Mesenchymal Stromal Cells in Patients Suffering Incomplete Spinal Cord Injury (SCI)', 'orgStudyIdInfo': {'id': 'CME-LEM2'}, 'secondaryIdInfos': [{'id': '2011-005684-24', 'type': 'REGISTRY', 'domain': '2011-005684-24'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Autologous Mesenchymal Bone Marrow Cell', 'description': 'All patients will be treated with the same treatment: Adult Autologous Mesenchymal Bone Marrow Cell', 'interventionNames': ['Biological: Adult Autologous Mesenchymal Bone Marrow Cell']}], 'interventions': [{'name': 'Adult Autologous Mesenchymal Bone Marrow Cell', 'type': 'BIOLOGICAL', 'description': 'Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells.', 'armGroupLabels': ['Autologous Mesenchymal Bone Marrow Cell']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28222', 'city': 'Majadahonda', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Puerta de Hierro', 'geoPoint': {'lat': 40.47353, 'lon': -3.87182}}], 'overallOfficials': [{'name': 'Jesús JV Vaquero Crespo, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario Puerta de Hierro-Majadahonda'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Anonymized individual data of participants will be shared with Authorities at the end of the Clinical development plan by the CTD (Common Technical Document). Results will be published in a scientific publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Puerta de Hierro University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jesús Vaquero Crespo, M.D.', 'investigatorAffiliation': 'Puerta de Hierro University Hospital'}}}}