NCT01673932

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: China Spinal Cord Injury Network · Network
• Sex: All
• Age: 35 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Stroke
• Ischemic Stroke
• Brain Ischemia

Interventions

Type	Name	Description
BIOLOGICAL	UCBMC	Transplant 10-40 million viable UCBMC suspension into brain adjacent to the infracted site
PROCEDURE	surgery

Timeline

• Start date: 2012-10-01
• Primary completion: 2018-12-01
• Completion: 2019-07-01
• First posted: 2012-08-28
• Last updated: 2018-01-31

Locations

2 sites across 1 country: Hong Kong