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

Recruiting

Phase 1 Results N/A

Trial Description

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.

Conditions

Interventions

  • Surgery Procedure
    ARM 1: Kind: Experimental
    Label: UCBMC, surgery
    Description: Subjects will receive transplant of UCBMC isolated from HLA-matched umbilical cord blood unit
    ARM 2: Kind: Experimental
    Label: Group A - UCBMC Early Treatment Group
    Description: Group A subjects will receive transplant of UCBMC isolated from HLA-matched umbilical cord blood at Day 0.
    ARM 3: Kind: Experimental
    Label: Group B - UCBMC Delayed Treatment Group
    Description: Group B subject will partipate in 6 months observation and then receive the UCBMC transplant at month 6.
  • UCBMC Biological
    Intervention Desc: Transplant 10-40 million viable UCBMC suspension into brain adjacent to the infracted site
    ARM 1: Kind: Experimental
    Label: UCBMC, surgery
    Description: Subjects will receive transplant of UCBMC isolated from HLA-matched umbilical cord blood unit
    ARM 2: Kind: Experimental
    Label: Group A - UCBMC Early Treatment Group
    Description: Group A subjects will receive transplant of UCBMC isolated from HLA-matched umbilical cord blood at Day 0.
    ARM 3: Kind: Experimental
    Label: Group B - UCBMC Delayed Treatment Group
    Description: Group B subject will partipate in 6 months observation and then receive the UCBMC transplant at month 6.

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary National Institutes of Health Stroke Scale up to 36 months Yes
Primary Primary Safety Outcome up to 36 months Yes
Secondary European Stroke Scale 12 months, up to 36 months if applicable Yes
Secondary Barthel Index 12 months Yes
Secondary Min-mental State Examination 12 months Yes
Secondary MRI 12 months Yes
Secondary European Stroke Scale (ESS) 12 months, up to 36 months if applicable Yes
Secondary Min-Mental State Examination (MMSE) 12 months Yes

Sponsors