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