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

  • STATUS
    Not Recruiting
  • participants needed
    12
  • sponsor
    China Spinal Cord Injury Network
Updated on 22 January 2021
Investigator
Waisang Poon, MD
Primary Contact
Prince of Wales Hospital (0.0 mi away) Contact
+1 other location
stroke
ischemic stroke
hemiparesis
hemiplegia

Summary

The study is to assess the safety and possible efficacy of umbilical cord blood mononuclear cells (UCBMC) treatment of chronic ischemic stroke.

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.

Details
Condition Cerebrovascular accident, Cerebral Ischemia, Ischemic Stroke
Treatment Surgery, UCBMC
Clinical Study IdentifierNCT01673932
SponsorChina Spinal Cord Injury Network
Last Modified on22 January 2021

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