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

Phase 1

• Conditions: Stroke; Ischemic Stroke; Brain Ischemia
• Interventions: Biological: UCBMC; Procedure: surgery

• Registration Number: NCT01673932
• Lead Sponsor: China Spinal Cord Injury Network

Brief 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.

Study Timeline

• Study First Submitted: 2012-08-24
• Study First Submitted QC: 2012-08-27
• Study First Posted: 2012-08-28
• Study Start: 2012-10
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-29
• Last Update Posted: 2018-01-31
• Primary Completion: 2018-12
• Study Completion: 2019-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B - UCBMC Delayed Treatment Group	surgery	Group B subject will partipate in 6 months observation and then receive the UCBMC transplant at month 6.
Group A - UCBMC Early Treatment Group	UCBMC	Group A subjects will receive transplant of UCBMC isolated from HLA-matched umbilical cord blood at Day 0.
Group B - UCBMC Delayed Treatment Group	UCBMC	Group B subject will partipate in 6 months observation and then receive the UCBMC transplant at month 6.
Group A - UCBMC Early Treatment Group	surgery	Group A subjects will receive transplant of UCBMC isolated from HLA-matched umbilical cord blood at Day 0.

Primary Outcome Measures

Name	Time	Method
National Institutes of Health Stroke Scale	18 months, up to 36 months	The change from the baseline in National Institutes of Health Stroke Scales

Secondary Outcome Measures

Name	Time	Method
Barthel Index	18 months
European Stroke Scale (ESS)	18 months, up to 36 months if applicable	The change from baseline in ESS
Min-Mental State Examination (MMSE)	18 months	The change from baseline in MMSE
MRI	18 months	The change in MRI between pre-treatment and post-treatment

Trial Locations

Locations (2)

Prince of Wales Hospital; 🇭🇰 Shatin, Hong Kong

Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong