Study of Purified Umbilical Cord Blood CD34+ Stem Cell on Chronic Ischemic Stroke

Not yet recruiting

Phase 1 Results N/A

Trial Description

The purpose of the study is to determine the safety and possible effectiveness of brain transplants of CD34+ stem cells obtained from umbilical cord blood (UCB) to treat stroke.

Detailed Description

The study will use CD34+ cells (a special kind of cell that is believed to be a stem cell) isolated from UCB (blood obtained at birth from the umbilical cord blood of babies). StemCyte, a leading accredited UCB banking company with branches in the United States and Taiwan, will provide the units of UCB that match at least 5 out of 6 HLA (human leukocyte antigens) for transplantation. The HLA-matching is the same as that used to match cells and organs for transplantation so that the body does not reject the cells. We will isolate CD34 cells from these units, purified them, suspend the cells in solution (1 ml containing 2-8 million cells), and inject the cells into brain around the site damaged by the stroke

Conditions

Interventions

  • Intercerebral implantation of allogenic CD34+ stem cell Procedure
    Other Names: Hematopoietic stem cell; Cord Blood Stem Cell; UCB Stem Cell
    Intervention Desc: Each patient will receive brain implant of approximately 5 million allogenic Umbilical cord blood CD34+ Stem Cell
    ARM 1: Kind: Experimental
    Label: HUCB, Medicine, Rehabilitation
    Description: Stroke patients are received intracerebral implantation of human cord blood stem cells (CD34+), Antiplatelet Medication, and Rehabilitation.

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change from baseline in NIH Stroke scale (NIHSS) Change from baseline in NIHSS at 12 weeks Yes
Secondary Change from Baseline in Brain Image Change from baseline in Brain image at 6 months Yes
Primary Change from Baseline in NIH Stroke Scale(NIHSS) Change from Baseline in NIHSS at 2 weeks Yes
Primary Change from baseline in NIH Stroke Scale Change from baseline in NIHSS at 4 weeks Yes
Primary Change from baseline in NIH Stroke Scale ( NIHSS) Change from baseline in NIHSS at 12 weeks Yes

Sponsors