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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Type :	Interventional (Clinical Trial)
Estimated 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 :	October 2012
Estimated Primary Completion Date :	December 2018
Estimated Study Completion Date :	July 2019

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Primary Outcome Measures :

1. 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 :

1. European Stroke Scale (ESS) [ Time Frame: 18 months, up to 36 months if applicable ]
   The change from baseline in ESS
2. Barthel Index [ Time Frame: 18 months ]
3. Min-Mental State Examination (MMSE) [ Time Frame: 18 months ]
   The change from baseline in MMSE
4. MRI [ Time Frame: 18 months ]
   The change in MRI between pre-treatment and post-treatment

Other Outcome Measures:

1. 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.

Eligibility Criteria

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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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	China Spinal Cord Injury Network
ClinicalTrials.gov Identifier:	NCT01673932 History of Changes
Other Study ID Numbers:	UCB-IS-01
First Posted:	August 28, 2012
Last Update Posted:	January 31, 2018
Last Verified:	January 2018

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