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

This study is currently recruiting participants.
Verified July 2016 by China Spinal Cord Injury Network
Sponsor:
ClinicalTrials.gov Identifier:
NCT01673932
First Posted: August 28, 2012
Last Update Posted: July 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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
  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
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

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

Primary Outcome Measures:
  • National Institutes of Health Stroke Scale [ Time Frame: 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) [ Time Frame: 18 months, up to 36 months if applicable ]
    The change from baseline in ESS

  • Barthel Index [ Time Frame: 18 months ]
  • Min-Mental State Examination (MMSE) [ Time Frame: 18 months ]
    The change from baseline in MMSE

  • MRI [ Time Frame: 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. [ Time Frame: 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.


Estimated Enrollment: 12
Study Start Date: October 2012
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: China Spinal Cord Injury Network
ClinicalTrials.gov Identifier: NCT01673932     History of Changes
Other Study ID Numbers: UCB-IS-01
First Submitted: August 24, 2012
First Posted: August 28, 2012
Last Update Posted: July 27, 2016
Last Verified: July 2016

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

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