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

Sponsor

China Spinal Cord Injury Network (Other)

Overall Status

Unknown status

CT.gov ID

NCT01673932

Collaborator

Chinese University of Hong Kong (Other), The University of Hong Kong (Other), Prince of Wales Hospital, Shatin, Hong Kong (Other), Queen Mary Hospital, Hong Kong (Other), StemCyte, Inc. (Industry)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Stroke Ischemic Stroke Brain Ischemia	Biological: UCBMC Procedure: surgery	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2012

Anticipated Primary Completion Date :

Dec 1, 2018

Anticipated Study Completion Date :

Jul 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group A - UCBMC Early Treatment Group Group A subjects will receive transplant of UCBMC isolated from HLA-matched umbilical cord blood at Day 0.	Biological: UCBMC Transplant 10-40 million viable UCBMC suspension into brain adjacent to the infracted site Procedure: surgery
Experimental: Group B - UCBMC Delayed Treatment Group Group B subject will partipate in 6 months observation and then receive the UCBMC transplant at month 6.	Biological: UCBMC Transplant 10-40 million viable UCBMC suspension into brain adjacent to the infracted site Procedure: surgery

Arm

Intervention/Treatment

Experimental: Group A - UCBMC Early Treatment Group

Group A subjects will receive transplant of UCBMC isolated from HLA-matched umbilical cord blood at Day 0.

Biological: UCBMC

Transplant 10-40 million viable UCBMC suspension into brain adjacent to the infracted site

Procedure: surgery

Experimental: Group B - UCBMC Delayed Treatment Group

Group B subject will partipate in 6 months observation and then receive the UCBMC transplant at month 6.

Biological: UCBMC

Transplant 10-40 million viable UCBMC suspension into brain adjacent to the infracted site

Procedure: surgery

Outcome Measures

Primary Outcome Measures

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

European Stroke Scale (ESS) [18 months, up to 36 months if applicable]
The change from baseline in ESS
Barthel Index [18 months]
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

Other Outcome Measures

Safety as assessed by the incidence and severity of adverse events, clinically-significant changes in lab tests, vital signs, physical and neurological examinations. [18 months, up to 36 months follow-up]
Safety are assessed by the incidence and severity of adverse events, clinically-significant changes in lab tests, vital signs, physical and neurological examinations.

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Queen Mary Hospital	Hong Kong		Hong Kong
2	Prince of Wales Hospital	Shatin		Hong Kong

Sponsors and Collaborators

China Spinal Cord Injury Network
Chinese University of Hong Kong
The University of Hong Kong
Prince of Wales Hospital, Shatin, Hong Kong
Queen Mary Hospital, Hong Kong
StemCyte, Inc.

Investigators

Principal Investigator: Waisang Poon, MD, The Chinese University of Hong Kong, Prince of Wales Hospital
Principal Investigator: Gilberto Ka Kit Leung, MD, The University of Hong Kong, Queen Mary Hospital