Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:37 PM
Study NCT ID:
NCT04811651
Status:
COMPLETED
Last Update Posted:
2024-09-25
First Post:
2021-03-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Umbilical Cord-derived Mesenchymal Stem Cells for Ischemic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Treatment and placebo solutions have identical appearance. Protocols will be designed to ensure that the physician evaluating patient safety and efficacy outcome as well as laboratory analysis, will not have access to the randomisation codes.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two different treatment groups; intravenous umbilical cord-derived mesenchymal stem cells or intravenous placebo solution'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 156}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-24', 'studyFirstSubmitDate': '2021-03-15', 'studyFirstSubmitQcDate': '2021-03-19', 'lastUpdatePostDateStruct': {'date': '2024-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Adverse Events', 'timeFrame': '360days'}], 'primaryOutcomes': [{'measure': 'Proportion of modified Rankin Scale (mRS) 0-2', 'timeFrame': '90 Days', 'description': 'the minimum and maximum values of mRS are 0 and 6, respectively; higher mRS mean a worse outcome'}], 'secondaryOutcomes': [{'measure': 'Proportion of modified Rankin Scale (mRS) 0-2', 'timeFrame': '180，360 Days', 'description': 'the minimum and maximum values of mRS are 0 and 6, respectively; higher mRS mean a worse outcome'}, {'measure': 'changes in Fugl-Meyer scale', 'timeFrame': '90days；180days；360days', 'description': 'Fugl-Meyer Assessment Scale ranges from 0 to 100.'}, {'measure': 'changes in Purdue hand function test', 'timeFrame': '90days；180days；360days', 'description': 'The changes of fine motor function were evaluated by Purdue hand function test'}, {'measure': 'changes in box and block test', 'timeFrame': '90days；180days；360days', 'description': 'The changes of fine motor function were evaluated by box and block test'}, {'measure': 'Proportion of modified Rankin Scale (mRS) 0-1', 'timeFrame': '90days；180days；360days', 'description': 'the minimum and maximum values of mRS are 0 and 6, respectively; higher mRS'}, {'measure': 'changes in the national institutes of health stroke scale (NIHSS)', 'timeFrame': '90days；180days；360days', 'description': 'NIHSS ranges from 0-42, and high NIHSS means bad outcome'}, {'measure': 'changes in Mini-mental State Examination (MMSE) score', 'timeFrame': '90days；180days；360days', 'description': 'MMSE score ranges from 0 to 30.'}, {'measure': 'changes in Montreal Cognitive Assessment (MoCA) score', 'timeFrame': '90days；180days；360days', 'description': 'MOCA score ranges from 0 to 30.'}, {'measure': 'The changes of head images', 'timeFrame': '90days；180days；360days', 'description': 'head images included flair, DTI'}, {'measure': 'changes in some serum biomarkers', 'timeFrame': '90days；180days；360days', 'description': 'serum biomarkers included CPEC, VEGF, BDNF, MMP-9'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ischemic Stroke', 'Stem Cell'], 'conditions': ['Ischemic Stroke']}, 'descriptionModule': {'briefSummary': 'This is a doble blind, placebo controlled clinical trial to assess safety and efficacy of intravenous administration of Umbilical cord-derived Mesenchymal Stem cells in patients with ischemic stroke within 6 months of onset.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age: 18-80 years old;\n2. Patients with anterior circulation cerebral infarction;\n3. NIHSS: 6-25, and the limb movement score is at least 2 points;\n4. Hemoglobin \\> 115g / L, platelet \\> 100 × 109 / L, leukocyte \\> 3 × 109 / L;\n5. the time from onset to treatment: group A（6-24 hours）、group B（1-3 days）、gourp C（4-7 days）、group D（1-4 weeks）、group E（1-6 months）;\n6. The patient or the legal representative of the patient can and is willing to sign the informed consent.\n\nExclusion Criteria:\n\n1. Patients who need or expect decompressive craniectomy;\n2. Patients who need or are expected to receive endovascular treatment ;\n3. Patients receiving intravenous thrombolysis;\n4. Disturbance of consciousness；\n5. Pregnant women or women of childbearing age who have not taken effective contraceptive measures;\n6. Intracranial hemorrhagic diseases: cerebral hemorrhage, subarachnoid hemorrhage, etc;\n7. Posterior circulation cerebral infarction;\n8. Tumor patients;\n9. Epilepsy patients;\n10. Severe neurological deficit caused by stroke (MRS = 5);\n11. Previous diseases with obvious functional impairment, such as Parkinson's disease, motor neuron disease, moderate Alzheimer's disease, osteoarthritis, etc;\n12. Patients with history of coagulation disorders, systemic bleeding tendency and thrombocytopenia (\\< 100000 / mm3);\n13. Chronic liver disease, liver and kidney dysfunction, elevated ALT or ast (2 times higher than the upper limit of normal value), elevated serum creatinine (1.5 times higher than the upper limit of normal value) or dependent on renal dialysis;\n14. Patients with moderate to severe mental illness obviously interfere with treatment compliance;\n15. Patients with high blood pressure (systolic blood pressure \\> 180mmhg) or low blood pressure (systolic blood pressure \\< 90mmHg);\n16. The expected survival time is less than one year;\n17. Those who have conducted other trials within 3 months;\n18. Other circumstances considered unsuitable by the researcher."}, 'identificationModule': {'nctId': 'NCT04811651', 'acronym': 'UMSIS', 'briefTitle': 'Umbilical Cord-derived Mesenchymal Stem Cells for Ischemic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'General Hospital of Shenyang Military Region'}, 'officialTitle': 'Umbilical Cord-derived Mesenchymal Stem Cells for Ischemic Stroke (UMSIS): a Prospective, Double-blinded, Randomized Controlled, Pilot Study', 'orgStudyIdInfo': {'id': 'k（2019）46'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group', 'description': 'intravenous umbilical cord derived mesenchymal stem cells', 'interventionNames': ['Biological: Umbilical Cord-derived Mesenchymal Stem Cells']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Comparator', 'description': 'intravenous placebo solution with the same appearance as the treatment group.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Umbilical Cord-derived Mesenchymal Stem Cells', 'type': 'BIOLOGICAL', 'description': 'umbilical cord derived mesenchymal stem cells were intravenously injected in a single dose of one hundred million.', 'armGroupLabels': ['Treatment group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'intravenous placebo solution with the same appearance as the treatment group.', 'armGroupLabels': ['Placebo Comparator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110016', 'city': 'Shenyang', 'country': 'China', 'facility': 'Department of Neurology, General Hospital of Northern Theater Command', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}], 'overallOfficials': [{'name': 'Chen Hui-Sheng, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'General Hospital of Shenyang Military Region'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'General Hospital of Shenyang Military Region', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of neurology department', 'investigatorFullName': 'Hui-Sheng Chen', 'investigatorAffiliation': 'General Hospital of Shenyang Military Region'}}}}