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

Recruiting

Phase 1 Results N/A

Update History

28 Jul '16
The description was updated.
New
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.
Old
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.
19 Dec '14
The description was updated.
New
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.
Old
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.
25 Apr '13
A location was updated in Hong Kong.
New
The overall status was updated to "Recruiting" at Queen Mary Hospital.
A location was updated in Shatin.
New
The overall status was updated to "Recruiting" at Prince of Wales Hospital.