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| Name | Class |
|---|---|
| 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 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A - UCBMC Early Treatment Group | Experimental | Group A subjects will receive transplant of UCBMC isolated from HLA-matched umbilical cord blood at Day 0. |
|
| Group B - UCBMC Delayed Treatment Group | Experimental | Group B subject will partipate in 6 months observation and then receive the UCBMC transplant at month 6. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UCBMC | Biological | Transplant 10-40 million viable UCBMC suspension into brain adjacent to the infracted site |
|
| 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 |
| 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 | |
| Measure | Description | Time Frame |
|---|---|---|
| Safety as assessed by the incidence and severity of adverse events, clinically-significant changes in lab tests, vital signs, physical and neurological examinations. | Safety are 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Mary Hospital | Recruiting | Hong Kong | Hong Kong |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| D002545 | Brain Ischemia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| OTHER |
| StemCyte, Inc. | INDUSTRY |
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| surgery | Procedure |
|
| 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 |
| Prince of Wales Hospital | Recruiting | Shatin | Hong Kong |
|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |