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

Stroke Clinical Trial

Official title:

Phase 1 Clinical Trial to Establish the Safety and Feasibility of Transplants of Umbilical Cord Blood Mononuclear Cells in Chronic Ischemic Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01673932
• Other study ID #: UCB-IS-01
• 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
• 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

Related Conditions & MeSH terms

• Brain Ischemia
• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

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