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Safety and Feasibility Study of Umbilical Cord Blood Mononuclear Cells Transplant to Treat Ischemic Stroke
This study is currently recruiting participants.
Verified July 2016 by China Spinal Cord Injury Network
Sponsor:
China Spinal Cord Injury Network
Collaborators:
Chinese University of Hong Kong
The University of Hong Kong
Prince of Wales Hospital, Shatin, Hong Kong
Queen Mary Hospital, Hong Kong
StemCyte, Inc.
Information provided by (Responsible Party):
China Spinal Cord Injury Network
ClinicalTrials.gov Identifier:
NCT01673932
First received: August 24, 2012
Last updated: July 25, 2016
Last verified: July 2016
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Purpose
The study is to assess the safety and possible efficacy of umbilical cord blood mononuclear cells (UCBMC) treatment of chronic ischemic stroke.
| Condition | Intervention | Phase |
|---|---|---|
| Stroke Ischemic Stroke Brain Ischemia | Biological: UCBMC Procedure: surgery | Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | Phase 1 Clinical Trial to Establish the Safety and Feasibility of Transplants of Umbilical Cord Blood Mononuclear Cells in Chronic Ischemic Stroke |
Further study details as provided by China Spinal Cord Injury Network:
Primary Outcome Measures:
- National Institutes of Health Stroke Scale [ Time Frame: 18 months, up to 36 months ]The change from the baseline in National Institutes of Health Stroke Scales
Secondary Outcome Measures:
- European Stroke Scale (ESS) [ Time Frame: 18 months, up to 36 months if applicable ]The change from baseline in ESS
- Barthel Index [ Time Frame: 18 months ]
- Min-Mental State Examination (MMSE) [ Time Frame: 18 months ]The change from baseline in MMSE
- MRI [ Time Frame: 18 months ]The change in MRI between pre-treatment and post-treatment
Other Outcome Measures:
- Safety as assessed by the incidence and severity of adverse events, clinically-significant changes in lab tests, vital signs, physical and neurological examinations. [ Time Frame: 18 months, up to 36 months follow-up ]Safety are assessed by the incidence and severity of adverse events, clinically-significant changes in lab tests, vital signs, physical and neurological examinations.
| Estimated Enrollment: | 12 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | July 2018 |
| Estimated Primary Completion Date: | December 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group A - UCBMC Early Treatment Group
Group A subjects will receive transplant of UCBMC isolated from HLA-matched umbilical cord blood at Day 0.
|
Biological: UCBMC
Transplant 10-40 million viable UCBMC suspension into brain adjacent to the infracted site
Procedure: surgery
|
|
Experimental: Group B - UCBMC Delayed Treatment Group
Group B subject will partipate in 6 months observation and then receive the UCBMC transplant at month 6.
|
Biological: UCBMC
Transplant 10-40 million viable UCBMC suspension into brain adjacent to the infracted site
Procedure: surgery
|
Detailed Description:
This is an open-label, delayed-treatment trial.
A 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.
The 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.
Eligibility| Ages Eligible for Study: | 35 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- either gender, age 35 -65 years old;
- ischemic stroke > 6 months and < 60 months;
- stable hemiplegia or hemiparesis condition > 3 months;
- stroke-induced clinical deficits affecting motor, perceptual, or language functions, with NIHSS of 5-15;
- stroke in the middle cerebral artery territory;
- subjects able to understand, sign and date the informed consent form
Exclusion Criteria:
- non-ischemic mechanism, subarachnoid hemorrhage, primary intracerebral or intraventricular hemorrhage;
- pregnant or lactating women;
- alcohol or drug abuse in previous 3 months;
- significant medical diseases or infections;
- current participation in another investigational study or taking any investigational drug within last 4 weeks before the screening;
- unavailability of HLA-matched umbilical cord blood unit;
- investigator suggests that the subject would not suitable to perform the surgery or participate in the study
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01673932
Please refer to this study by its ClinicalTrials.gov identifier: NCT01673932
Locations
| Hong Kong | |
| Queen Mary Hospital | Recruiting |
| Hong Kong, Hong Kong | |
| Contact: Karrie Kiang +852 2255 4468 mykiang@hku.hk | |
| Principal Investigator: Gilberto Ka Kit Leung, MD | |
| Prince of Wales Hospital | Recruiting |
| Shatin, Hong Kong | |
| Contact: Waisang Poon, MD +852 2632 1625 stroke-study@surgery.cuhk.edu.hk | |
| Principal Investigator: Waisang Poon, MD | |
Sponsors and Collaborators
China Spinal Cord Injury Network
Chinese University of Hong Kong
The University of Hong Kong
Prince of Wales Hospital, Shatin, Hong Kong
Queen Mary Hospital, Hong Kong
StemCyte, Inc.
Investigators
| Principal Investigator: | Waisang Poon, MD | The Chinese University of Hong Kong, Prince of Wales Hospital |
| Principal Investigator: | Gilberto Ka Kit Leung, MD | The University of Hong Kong, Queen Mary Hospital |
More Information
| Responsible Party: | China Spinal Cord Injury Network |
| ClinicalTrials.gov Identifier: | NCT01673932 History of Changes |
| Other Study ID Numbers: |
UCB-IS-01 |
| Study First Received: | August 24, 2012 |
| Last Updated: | July 25, 2016 |
Keywords provided by China Spinal Cord Injury Network:
|
stroke chronic stroke ischemic stroke |
umbilical cord blood mononuclear cell transplant |
Additional relevant MeSH terms:
|
Stroke Ischemia Cerebral Infarction Brain Ischemia Cerebrovascular Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Pathologic Processes Brain Infarction |
ClinicalTrials.gov processed this record on September 19, 2017