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

China Spinal Cord Injury Network

Status and phase: Unknown; Phase 1

Conditions: Brain Ischemia; Ischemic Stroke; Stroke

Treatments: Biological: UCBMC; Procedure: surgery

Study type: Interventional

Funder types: Other; NETWORK; Industry

Identifiers

NCT01673932

UCB-IS-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 35 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Group A - UCBMC Early Treatment Group

Experimental group

Description:

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

Treatment:

Procedure: surgery

Biological: UCBMC

Group B - UCBMC Delayed Treatment Group

Experimental group

Description:

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

Treatment:

Procedure: surgery

Biological: UCBMC