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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01673932
Other study ID # UCB-IS-01
Secondary ID
Status Recruiting
Phase Phase 1
First received August 24, 2012
Last updated January 29, 2018
Start date October 2012
Est. completion date July 2019

Study information

Verified date January 2018
Source China Spinal Cord Injury Network
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 12
Est. completion date July 2019
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group 35 Years to 65 Years
Eligibility 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 Design


Intervention

Biological:
UCBMC
Transplant 10-40 million viable UCBMC suspension into brain adjacent to the infracted site
Procedure:
surgery


Locations

Country Name City State
Hong Kong Queen Mary Hospital Hong Kong
Hong Kong Prince of Wales Hospital Shatin

Sponsors (6)

Lead Sponsor Collaborator
China Spinal Cord Injury Network Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong, Queen Mary Hospital, Hong Kong, StemCyte, Inc., The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

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