Clinical trial NCT01673932: 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
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Stroke
Ischemic Stroke
Brain Ischemia
Keywords: stroke
chronic stroke
ischemic stroke
umbilical cord blood
mononuclear cell
transplant
Lead sponsor: China Spinal Cord Injury Network
Sponsor class: NETWORK
Collaborators: name: Chinese University of Hong Kong
name: The University of Hong Kong
name: Prince of Wales Hospital, Shatin, Hong Kong
name: Queen Mary Hospital, Hong Kong
name: StemCyte, Inc.
First posted: 2012-08-28
Enrollment: 12
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: National Institutes of Health Stroke Scale
timeFrame: 18 months, up to 36 months
Secondary outcomes:
measure: European Stroke Scale (ESS)
timeFrame: 18 months, up to 36 months if applicable
measure: Barthel Index
timeFrame: 18 months
measure: Min-Mental State Examination (MMSE)
timeFrame: 18 months
measure: MRI
timeFrame: 18 months
Other outcomes:
measure: Safety as assessed by the incidence and severity of adverse events, clinically-significant changes in lab tests, vital signs, physical and neurological examinations.
timeFrame: 18 months, up to 36 months follow-up
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
affiliation: The Chinese University of Hong Kong, Prince of Wales Hospital
name: Waisang Poon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Hong Kong, Queen Mary Hospital
name: Gilberto Ka Kit Leung, MD
role: PRINCIPAL_INVESTIGATOR
References: