Safety and Feasibility Study of Umbilical Cord Blood Mononuclear Cells Transplant to Treat Ischemic Stroke
NCT ID: NCT01673932
Last Updated: 2018-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
12 participants
INTERVENTIONAL
2012-10-31
2019-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group A - UCBMC Early Treatment Group
Group A subjects will receive transplant of UCBMC isolated from HLA-matched umbilical cord blood at Day 0.
UCBMC
Transplant 10-40 million viable UCBMC suspension into brain adjacent to the infracted site
surgery
Group B - UCBMC Delayed Treatment Group
Group B subject will partipate in 6 months observation and then receive the UCBMC transplant at month 6.
UCBMC
Transplant 10-40 million viable UCBMC suspension into brain adjacent to the infracted site
surgery
Interventions
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UCBMC
Transplant 10-40 million viable UCBMC suspension into brain adjacent to the infracted site
surgery
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
35 Years
65 Years
ALL
No
Sponsors
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Chinese University of Hong Kong
OTHER
The University of Hong Kong
OTHER
Prince of Wales Hospital, Shatin, Hong Kong
OTHER
Queen Mary Hospital, Hong Kong
OTHER
StemCyte, Inc.
INDUSTRY
China Spinal Cord Injury Network
NETWORK
Responsible Party
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Principal Investigators
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Waisang Poon, MD
Role: PRINCIPAL_INVESTIGATOR
The Chinese University of Hong Kong, Prince of Wales Hospital
Gilberto Ka Kit Leung, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Hong Kong, Queen Mary Hospital
Locations
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Queen Mary Hospital
Hong Kong, , Hong Kong
Prince of Wales Hospital
Shatin, , Hong Kong
Countries
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Facility Contacts
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Other Identifiers
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UCB-IS-01
Identifier Type: -
Identifier Source: org_study_id
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