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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. (see Contacts and Locations)
Verified December 2014 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: December 16, 2014
Last verified: December 2014

August 24, 2012
December 16, 2014
October 2012
December 2016   (final data collection date for primary outcome measure)
National Institutes of Health Stroke Scale [ Time Frame: 18 months, up to 36 months ] [ Designated as safety issue: Yes ]
The change from the baseline in National Institutes of Health Stroke Scales
  • National Institutes of Health Stroke Scale [ Time Frame: up to 36 months ] [ Designated as safety issue: Yes ]
  • Primary Safety Outcome [ Time Frame: up to 36 months ] [ Designated as safety issue: Yes ]
    adverse events, serious adverse events, vital signs, lab parameters and CT
Complete list of historical versions of study NCT01673932 on ClinicalTrials.gov Archive Site
  • European Stroke Scale (ESS) [ Time Frame: 18 months, up to 36 months if applicable ] [ Designated as safety issue: Yes ]
    The change from baseline in ESS
  • Barthel Index [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
  • Min-Mental State Examination (MMSE) [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    The change from baseline in MMSE
  • MRI [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
    The change in MRI between pre-treatment and post-treatment
  • European Stroke Scale [ Time Frame: 12 months, up to 36 months if applicable ] [ Designated as safety issue: Yes ]
  • Barthel Index [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Min-mental State Examination [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • MRI [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
Safety are assessed by the incidence and severity of adverse events, clinically-significant changes in lab tests, vital signs, physical and neurological examinations.
Not Provided
 
Safety and Feasibility Study of Umbilical Cord Blood Mononuclear Cells Transplant to Treat Ischemic Stroke
Phase 1 Clinical Trial to Establish the Safety and Feasibility of Transplants of Umbilical Cord Blood Mononuclear Cells in Chronic Ischemic Stroke

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

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Stroke
  • Ischemic Stroke
  • Brain Ischemia
  • Biological: UCBMC
    Transplant 10-40 million viable UCBMC suspension into brain adjacent to the infracted site
  • Procedure: surgery
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
12
July 2017
December 2016   (final data collection date for primary outcome measure)

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
Both
35 Years to 65 Years
No
Hong Kong
 
NCT01673932
UCB-IS-01
Yes
China Spinal Cord Injury Network
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.
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
China Spinal Cord Injury Network
December 2014

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