Safety and Feasibility Study of Umbilical Cord Blood Mononuclear Cells Transplant to Treat Ischemic Stroke

Study Overview
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Brief Summary
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The study is to assess the safety and possible efficacy of umbilical cord blood mononuclear cells (UCBMC) treatment of chronic ischemic stroke.

Detailed Description
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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.

Official Title
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Phase 1 Clinical Trial to Establish the Safety and Feasibility of Transplants of Umbilical Cord Blood Mononuclear Cells in Chronic Ischemic Stroke

Conditions
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Stroke, Ischemic Stroke, Brain Ischemia

Intervention / Treatment
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* Biological: UCBMC
* Procedure: surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A - UCBMC Early Treatment Group<br>Group A subjects will receive transplant of UCBMC isolated from HLA-matched umbilical cord blood at Day 0. | Biological: UCBMC<br>* Transplant 10-40 million viable UCBMC suspension into brain adjacent to the infracted site<br>Procedure: surgery<br> <br> |
| Experimental: Group B - UCBMC Delayed Treatment Group<br>Group B subject will partipate in 6 months observation and then receive the UCBMC transplant at month 6. | Biological: UCBMC<br>* Transplant 10-40 million viable UCBMC suspension into brain adjacent to the infracted site<br>Procedure: surgery<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| National Institutes of Health Stroke Scale | The change from the baseline in National Institutes of Health Stroke Scales | 18 months, up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| European Stroke Scale (ESS) | The change from baseline in ESS | 18 months, up to 36 months if applicable | 
| Barthel Index |  | 18 months | 
| Min-Mental State Examination (MMSE) | The change from baseline in MMSE | 18 months | 
| MRI | The change in MRI between pre-treatment and post-treatment | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, chronic stroke, ischemic stroke, umbilical cord blood, mononuclear cell, transplant