Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2026-01-02 @ 1:44 PM
Study NCT ID:
NCT01673932
Status:
UNKNOWN
Last Update Posted:
2018-01-31
First Post:
2012-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Feasibility Study of Umbilical Cord Blood Mononuclear Cells Transplant to Treat Ischemic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D002545', 'term': 'Brain Ischemia'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-29', 'studyFirstSubmitDate': '2012-08-24', 'studyFirstSubmitQcDate': '2012-08-27', 'lastUpdatePostDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-08-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safety as assessed by the incidence and severity of adverse events, clinically-significant changes in lab tests, vital signs, physical and neurological examinations.', 'timeFrame': '18 months, up to 36 months follow-up', 'description': 'Safety are assessed by the incidence and severity of adverse events, clinically-significant changes in lab tests, vital signs, physical and neurological examinations.'}], 'primaryOutcomes': [{'measure': 'National Institutes of Health Stroke Scale', 'timeFrame': '18 months, up to 36 months', 'description': 'The change from the baseline in National Institutes of Health Stroke Scales'}], 'secondaryOutcomes': [{'measure': 'European Stroke Scale (ESS)', 'timeFrame': '18 months, up to 36 months if applicable', 'description': 'The change from baseline in ESS'}, {'measure': 'Barthel Index', 'timeFrame': '18 months'}, {'measure': 'Min-Mental State Examination (MMSE)', 'timeFrame': '18 months', 'description': 'The change from baseline in MMSE'}, {'measure': 'MRI', 'timeFrame': '18 months', 'description': 'The change in MRI between pre-treatment and post-treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stroke', 'chronic stroke', 'ischemic stroke', 'umbilical cord blood', 'mononuclear cell', 'transplant'], 'conditions': ['Stroke', 'Ischemic Stroke', 'Brain Ischemia']}, 'descriptionModule': {'briefSummary': 'The study is to assess the safety and possible efficacy of umbilical cord blood mononuclear cells (UCBMC) treatment of chronic ischemic stroke.', 'detailedDescription': 'This is an open-label, delayed-treatment trial.\n\nA total of 12 subjects fulfill the inclusion and exclusion criteria will be recruited and randomly assigned into two treatment group. Group A (early-treatment group) will receive transplant of UCBMC isolated from HLA-matched umbilical cord blood at Day 0. Group B (delayed-treatment group) will participate in 6 months observation before the UCBMC transplantation at Month 6. All subjects will be followed up for 18 months from enrollment at Day 0. Long-term follow-up will be carried up to 36 months if applicable.\n\nThe adverse events and safety parameters will be collected and recorded. In addition, the stroke scores , gait and brain MRI will be obtained before and after the treatment to assess the safety and potential treatment effect of UCBMC in chronic ischemic stroke.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* either gender, age 35 -65 years old;\n* ischemic stroke \\> 6 months and \\< 60 months;\n* stable hemiplegia or hemiparesis condition \\> 3 months;\n* stroke-induced clinical deficits affecting motor, perceptual, or language functions, with NIHSS of 5-15;\n* stroke in the middle cerebral artery territory;\n* subjects able to understand, sign and date the informed consent form\n\nExclusion Criteria:\n\n* non-ischemic mechanism, subarachnoid hemorrhage, primary intracerebral or intraventricular hemorrhage;\n* pregnant or lactating women;\n* alcohol or drug abuse in previous 3 months;\n* significant medical diseases or infections;\n* current participation in another investigational study or taking any investigational drug within last 4 weeks before the screening;\n* unavailability of HLA-matched umbilical cord blood unit;\n* investigator suggests that the subject would not suitable to perform the surgery or participate in the study'}, 'identificationModule': {'nctId': 'NCT01673932', 'briefTitle': 'Safety and Feasibility Study of Umbilical Cord Blood Mononuclear Cells Transplant to Treat Ischemic Stroke', 'organization': {'class': 'NETWORK', 'fullName': 'China Spinal Cord Injury Network'}, 'officialTitle': 'Phase 1 Clinical Trial to Establish the Safety and Feasibility of Transplants of Umbilical Cord Blood Mononuclear Cells in Chronic Ischemic Stroke', 'orgStudyIdInfo': {'id': 'UCB-IS-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A - UCBMC Early Treatment Group', 'description': 'Group A subjects will receive transplant of UCBMC isolated from HLA-matched umbilical cord blood at Day 0.', 'interventionNames': ['Biological: UCBMC', 'Procedure: surgery']}, {'type': 'EXPERIMENTAL', 'label': 'Group B - UCBMC Delayed Treatment Group', 'description': 'Group B subject will partipate in 6 months observation and then receive the UCBMC transplant at month 6.', 'interventionNames': ['Biological: UCBMC', 'Procedure: surgery']}], 'interventions': [{'name': 'UCBMC', 'type': 'BIOLOGICAL', 'description': 'Transplant 10-40 million viable UCBMC suspension into brain adjacent to the infracted site', 'armGroupLabels': ['Group A - UCBMC Early Treatment Group', 'Group B - UCBMC Delayed Treatment Group']}, {'name': 'surgery', 'type': 'PROCEDURE', 'armGroupLabels': ['Group A - UCBMC Early Treatment Group', 'Group B - UCBMC Delayed Treatment Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Karrie Kiang', 'role': 'CONTACT', 'email': 'mykiang@hku.hk', 'phone': '+852 2255 4468'}, {'name': 'Gilberto Ka Kit Leung, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Queen Mary Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Shatin', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Waisang Poon, MD', 'role': 'CONTACT', 'email': 'stroke-study@surgery.cuhk.edu.hk', 'phone': '+852 2632 1625'}, {'name': 'Waisang Poon, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Prince of Wales Hospital', 'geoPoint': {'lat': 22.38333, 'lon': 114.18333}}], 'overallOfficials': [{'name': 'Waisang Poon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Chinese University of Hong Kong, Prince of Wales Hospital'}, {'name': 'Gilberto Ka Kit Leung, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Hong Kong, Queen Mary Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China Spinal Cord Injury Network', 'class': 'NETWORK'}, 'collaborators': [{'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, {'name': 'The University of Hong Kong', 'class': 'OTHER'}, {'name': 'Prince of Wales Hospital, Shatin, Hong Kong', 'class': 'OTHER'}, {'name': 'Queen Mary Hospital, Hong Kong', 'class': 'OTHER'}, {'name': 'StemCyte, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}