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

Primary Purpose

Stroke, Ischemic Stroke, Brain Ischemia

Status

Unknown status

Phase

Phase 1

Locations

Hong Kong

Study Type

Interventional

Intervention

UCBMC

surgery

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, chronic stroke, ischemic stroke, umbilical cord blood, mononuclear cell, transplant

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Queen Mary HospitalRecruiting
Prince of Wales HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Group A - UCBMC Early Treatment Group

Group B - UCBMC Delayed Treatment Group

Arm Description

Group A subjects will receive transplant of UCBMC isolated from HLA-matched umbilical cord blood at Day 0.

Group B subject will partipate in 6 months observation and then receive the UCBMC transplant at month 6.

Outcomes

Primary Outcome Measures

National Institutes of Health Stroke Scale

The change from the baseline in National Institutes of Health Stroke Scales

Secondary Outcome Measures

European Stroke Scale (ESS)

The change from baseline in ESS

Barthel Index

Min-Mental State Examination (MMSE)

The change from baseline in MMSE

MRI

The change in MRI between pre-treatment and post-treatment

Full Information

NCT ID

NCT01673932

First Posted

August 24, 2012

Last Updated

January 29, 2018

Sponsor

China Spinal Cord Injury Network

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.

1. Study Identification

Unique Protocol Identification Number

NCT01673932

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Unknown status

Study Start Date

October 2012 (undefined)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

July 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

China Spinal Cord Injury Network

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.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Ischemic Stroke, Brain Ischemia

Keywords

stroke, chronic stroke, ischemic stroke, umbilical cord blood, mononuclear cell, transplant

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group A - UCBMC Early Treatment Group

Arm Type

Experimental

Arm Description

Group A subjects will receive transplant of UCBMC isolated from HLA-matched umbilical cord blood at Day 0.

Arm Title

Group B - UCBMC Delayed Treatment Group

Arm Type

Experimental

Arm Description

Group B subject will partipate in 6 months observation and then receive the UCBMC transplant at month 6.

Intervention Type

Biological

Intervention Name(s)

UCBMC

Intervention Description

Transplant 10-40 million viable UCBMC suspension into brain adjacent to the infracted site

Intervention Type

Procedure

Intervention Name(s)

surgery

Primary Outcome Measure Information:

Title

National Institutes of Health Stroke Scale

Description

The change from the baseline in National Institutes of Health Stroke Scales

Time Frame

18 months, up to 36 months

Secondary Outcome Measure Information:

Title

European Stroke Scale (ESS)

Description

The change from baseline in ESS

Time Frame

18 months, up to 36 months if applicable

Title

Barthel Index

Time Frame

18 months

Title

Min-Mental State Examination (MMSE)

Description

The change from baseline in MMSE

Time Frame

18 months

Title

MRI

Description

The change in MRI between pre-treatment and post-treatment

Time Frame

18 months

Other Pre-specified Outcome Measures:

Title

Safety as assessed by the incidence and severity of adverse events, clinically-significant changes in lab tests, vital signs, physical and neurological examinations.

Description

Safety are 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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Waisang Poon, MD

Organizational Affiliation

The Chinese University of Hong Kong, Prince of Wales Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Gilberto Ka Kit Leung, MD

Organizational Affiliation

The University of Hong Kong, Queen Mary Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Queen Mary Hospital

City

Hong Kong

Country

Hong Kong

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Karrie Kiang

Phone

+852 2255 4468

mykiang@hku.hk

First Name & Middle Initial & Last Name & Degree

Gilberto Ka Kit Leung, MD

Facility Name

Prince of Wales Hospital

City

Shatin

Country

Hong Kong

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Waisang Poon, MD

Phone

+852 2632 1625

stroke-study@surgery.cuhk.edu.hk

First Name & Middle Initial & Last Name & Degree

Waisang Poon, MD

12. IPD Sharing Statement

Learn more about this trial

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

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