Brain Ischemia, Ischemic Stroke, Stroke
Conditions
Keywords
stroke, chronic stroke, ischemic stroke, umbilical cord blood, mononuclear cell, transplant
Brief summary
The study is to assess the safety and possible efficacy of umbilical cord blood mononuclear cells (UCBMC) treatment of chronic ischemic stroke.
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.
Interventions
BIOLOGICALUCBMC
Transplant 10-40 million viable UCBMC suspension into brain adjacent to the infracted site
PROCEDUREsurgery
Sponsors
Chinese University of Hong Kong
The University of Hong Kong
Prince of Wales Hospital, Shatin, Hong Kong
Queen Mary Hospital, Hong Kong
StemCyte, Inc.
China Spinal Cord Injury Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| National Institutes of Health Stroke Scale | 18 months, up to 36 months | The change from the baseline in National Institutes of Health Stroke Scales |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| European Stroke Scale (ESS) | 18 months, up to 36 months if applicable | The change from baseline in ESS |
| Barthel Index | 18 months | — |
| Min-Mental State Examination (MMSE) | 18 months | The change from baseline in MMSE |
| MRI | 18 months | The change in MRI between pre-treatment and post-treatment |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety as assessed by the incidence and severity of adverse events, clinically-significant changes in lab tests, vital signs, physical and neurological examinations. | 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. |
Countries
Hong Kong
Outcome results
None listed