Trial record 8 of 9 for:
Spinal Cord Infarction
Safety and Feasibility Study of Umbilical Cord Blood Mononuclear Cells Transplant to Treat Ischemic Stroke
This study is currently recruiting participants.
Verified April 2013 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: April 22, 2013
Last verified: April 2013
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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: 12 months, up to 36 months ] [ Designated as safety issue: Yes ]The change from the baseline in National Institutes of Health Stroke Scales
- Primary Safety Outcome [ Time Frame: 12 months, up to 36 months followup ] [ Designated as safety issue: Yes ]The primary endpoint will be the safety of UCBMC treatment as determined by the incidence and severity of adverse events, clinically-significant changes on clinical laboratory tests, vital signs, physical and neurological examinations.
Secondary Outcome Measures:
- European Stroke Scale (ESS) [ Time Frame: 12 months, up to 36 months if applicable ] [ Designated as safety issue: Yes ]The change from baseline in ESS
- Barthel Index [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Min-Mental State Examination (MMSE) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]The change from baseline in MMSE
- MRI [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]The change in MRI between pre-treatment and post-treatment
| Estimated Enrollment: | 12 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | March 2016 |
| Estimated Primary Completion Date: | January 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: UCBMC, surgery
Subjects will receive transplant of UCBMC isolated from HLA-matched umbilical cord blood unit
|
Biological: UCBMC
Inject 10-40 million viable UCBMC (umbilical cord blood mononuclear cells) suspension into brain adjacent to the infract
Procedure: surgery
|
|
No Intervention: Control
The control group will receive standard treatment which does not involve interventional treatment
|
Detailed Description:
This is an open-label randomized controlled study. Subjects fulfill the inclusion and exclusion criteria will be recruited and randomly assigned to treatment group or control group. The subjects in the treatment group will receive transplant of UCBMC isolated from HLA-matched cord blood unit. The subjects in the control group will receive standard routine treatment which do not involve interventional treatment. All subjects will be followed up for at least 12 months. Long-term follow-up will be carried up to 36 months if applicable.
The adverse events and safety parameters will be record and assessed. 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 |
| Genders Eligible for Study: | Both |
| 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
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
No publications provided
| 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: | April 22, 2013 |
| Health Authority: | Hong Kong: Ethics Committee Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee |
Keywords provided by China Spinal Cord Injury Network:
|
stroke chronic stroke ischemic stroke |
umbilical cord blood umbilical cord blood mononuclear cells transplant |
Additional relevant MeSH terms:
|
Cerebral Infarction Brain Infarction Brain Ischemia Ischemia Stroke Cerebrovascular Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013