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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by China Spinal Cord Injury Network
Sponsor:
Collaborators:
Chinese University of Hong Kong
The University of Hong Kong
Prince of Wales Hospital, Shatin, Hong Kong
Queen Mary Hospital, Hong Kong
StemCyte, Inc.
Information provided by (Responsible Party):
China Spinal Cord Injury Network
ClinicalTrials.gov Identifier:
NCT01673932
First received: August 24, 2012
Last updated: April 22, 2013
Last verified: April 2013
  Purpose

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


Condition Intervention Phase
Stroke
Ischemic Stroke
Brain Ischemia
Biological: UCBMC
Procedure: surgery
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by China Spinal Cord Injury Network:

Primary Outcome Measures:
  • National Institutes of Health Stroke Scale [ Time Frame: 12 months, up to 36 months ] [ Designated as safety issue: Yes ]
    The change from the baseline in National Institutes of Health Stroke Scales

  • Primary Safety Outcome [ Time Frame: 12 months, up to 36 months followup ] [ Designated as safety issue: Yes ]
    The primary endpoint will be the safety of UCBMC treatment as determined by the incidence and severity of adverse events, clinically-significant changes on clinical laboratory tests, vital signs, physical and neurological examinations.


Secondary Outcome Measures:
  • European Stroke Scale (ESS) [ Time Frame: 12 months, up to 36 months if applicable ] [ Designated as safety issue: Yes ]
    The change from baseline in ESS

  • Barthel Index [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Min-Mental State Examination (MMSE) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    The change from baseline in MMSE

  • MRI [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    The change in MRI between pre-treatment and post-treatment


Estimated Enrollment: 12
Study Start Date: October 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: UCBMC, surgery
Subjects will receive transplant of UCBMC isolated from HLA-matched umbilical cord blood unit
Biological: UCBMC
Inject 10-40 million viable UCBMC (umbilical cord blood mononuclear cells) suspension into brain adjacent to the infract
Procedure: surgery
No Intervention: Control
The control group will receive standard treatment which does not involve interventional treatment

Detailed Description:

This is an open-label randomized controlled study. Subjects fulfill the inclusion and exclusion criteria will be recruited and randomly assigned to treatment group or control group. The subjects in the treatment group will receive transplant of UCBMC isolated from HLA-matched cord blood unit. The subjects in the control group will receive standard routine treatment which do not involve interventional treatment. All subjects will be followed up for at least 12 months. Long-term follow-up will be carried up to 36 months if applicable.

The adverse events and safety parameters will be record and assessed. 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.

  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01673932

Locations
Hong Kong
Queen Mary Hospital Recruiting
Hong Kong, Hong Kong
Contact: Karrie Kiang    +852 2255 4468    mykiang@hku.hk   
Principal Investigator: Gilberto Ka Kit Leung, MD         
Prince of Wales Hospital Recruiting
Shatin, Hong Kong
Contact: Waisang Poon, MD    +852 2632 1625    stroke-study@surgery.cuhk.edu.hk   
Principal Investigator: Waisang Poon, MD         
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
  More Information

No publications provided

Responsible Party: China Spinal Cord Injury Network
ClinicalTrials.gov Identifier: NCT01673932     History of Changes
Other Study ID Numbers: UCB-IS-01
Study First Received: August 24, 2012
Last Updated: April 22, 2013
Health Authority: Hong Kong: Ethics Committee
Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by China Spinal Cord Injury Network:
stroke
chronic stroke
ischemic stroke
umbilical cord blood
umbilical cord blood mononuclear cells
transplant

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Ischemia
Brain Ischemia
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction

ClinicalTrials.gov processed this record on September 16, 2014