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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01673932
Recruitment Status : Unknown
Verified January 2018 by China Spinal Cord Injury Network.
Recruitment status was:  Recruiting
First Posted : August 28, 2012
Last Update Posted : January 31, 2018
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

Tracking Information
First Submitted Date  ICMJE August 24, 2012
First Posted Date  ICMJE August 28, 2012
Last Update Posted Date January 31, 2018
Study Start Date  ICMJE October 2012
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2014)
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
Original Primary Outcome Measures  ICMJE
 (submitted: August 27, 2012)
  • National Institutes of Health Stroke Scale [ Time Frame: 12 months, up to 36 months ]
    The change from the baseline in National Institutes of Health Stroke Scales
  • Primary Safety Outcome [ Time Frame: 12 months, up to 36 months followup ]
    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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2014)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: August 27, 2012)
  • European Stroke Scale (ESS) [ Time Frame: 12 months, up to 36 months if applicable ]
    The change from baseline in ESS
  • Barthel Index [ Time Frame: 12 months ]
  • Min-Mental State Examination (MMSE) [ Time Frame: 12 months ]
    The change from baseline in MMSE
  • MRI [ Time Frame: 12 months ]
    The change in MRI between pre-treatment and post-treatment
Current Other Pre-specified Outcome Measures
 (submitted: December 16, 2014)
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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Feasibility Study of Umbilical Cord Blood Mononuclear Cells Transplant to Treat Ischemic Stroke
Official Title  ICMJE Phase 1 Clinical Trial to Establish the Safety and Feasibility of Transplants of Umbilical Cord Blood Mononuclear Cells in Chronic Ischemic Stroke
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Stroke
  • Ischemic Stroke
  • Brain Ischemia
Intervention  ICMJE
  • Biological: UCBMC
    Transplant 10-40 million viable UCBMC suspension into brain adjacent to the infracted site
  • Procedure: surgery
Study Arms  ICMJE
  • 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.
    Interventions:
    • Biological: UCBMC
    • 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.
    Interventions:
    • Biological: UCBMC
    • Procedure: surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 27, 2012)
12
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2019
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01673932
Other Study ID Numbers  ICMJE UCB-IS-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party China Spinal Cord Injury Network
Study Sponsor  ICMJE China Spinal Cord Injury Network
Collaborators  ICMJE
  • 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  ICMJE
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
PRS Account China Spinal Cord Injury Network
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP