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