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.

Study Overview

• Status: Unknown
• Conditions: Stroke; Ischemic Stroke; Brain Ischemia
• Intervention / Treatment: Procedure: surgery; Biological: UCBMC

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: Interventional
• Enrollment (Anticipated): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.	Procedure: surgery; Biological: UCBMC; Transplant 10-40 million viable UCBMC suspension into brain adjacent to the infracted site
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.	Procedure: surgery; Biological: UCBMC; Transplant 10-40 million viable UCBMC suspension into brain adjacent to the infracted site

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
National Institutes of Health Stroke Scale	The change from the baseline in National Institutes of Health Stroke Scales	18 months, up to 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
European Stroke Scale (ESS)	The change from baseline in ESS	18 months, up to 36 months if applicable
Barthel Index		18 months
Min-Mental State Examination (MMSE)	The change from baseline in MMSE	18 months
MRI	The change in MRI between pre-treatment and post-treatment	18 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety as assessed by the incidence and severity of adverse events, clinically-significant changes in lab tests, vital signs, physical and neurological examinations.	Safety are assessed by the incidence and severity of adverse events, clinically-significant changes in lab tests, vital signs, physical and neurological examinations.	18 months, up to 36 months follow-up

Collaborators and Investigators

• Sponsor: China Spinal Cord Injury Network
• Collaborators: The University of Hong Kong; Chinese 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

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): July 1, 2019

Study Registration Dates

• First Submitted: August 24, 2012
• First Submitted That Met QC Criteria: August 27, 2012
• First Posted (Estimate): August 28, 2012

Study Record Updates

• Last Update Posted (Actual): January 31, 2018
• Last Update Submitted That Met QC Criteria: January 29, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: transplant; stroke; ischemic stroke; umbilical cord blood; chronic stroke; mononuclear cell
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Brain Ischemia; Ischemia; Cerebral Infarction
• Other Study ID Numbers: UCB-IS-01