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

China Spinal Cord Injury Network12 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stroke Ischemic Stroke Brain Ischemia

Interventions

UCBMCBIOLOGICAL

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

surgeryPROCEDURE

Eligibility

Sex: ALLMin age: 35 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (2)

Queen Mary Hospital

Hong Kong, Hong Kong

RECRUITING

Prince of Wales Hospital

Shatin, Hong Kong

RECRUITING

Outcomes

Primary Outcomes

National Institutes of Health Stroke Scale

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

Time frame: 18 months, up to 36 months

Secondary Outcomes

European Stroke Scale (ESS)

The change from baseline in ESS

Time frame: 18 months, up to 36 months if applicable

Barthel Index

Time frame: 18 months

Min-Mental State Examination (MMSE)

The change from baseline in MMSE

Time frame: 18 months

MRI

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

Time frame: 18 months

Data from ClinicalTrials.gov

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