Phase I Clinical Safety Study About Human Umbilical Cord Blood Monocyte in the Acute Ischemic Stroke

Recruiting

Phase 1 Results N/A

Trial Description

The objective of the study is to determine the safely of Human Umbilical Cord Blood mononuclear cells by Intravenous injection in acute ischemic stroke patients.

Detailed Description

The study will use Umbilical Cord Blood 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 6 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. Then cells injection by Intravenous in acute ischemic stroke patients.

Conditions

Interventions

  • Intravenous Human Umbilical Cord Blood Monocyte Biological
    Intervention Desc: Each patient will receive Intravenous of approximately 200-500 million Umbilical cord blood cell. Combined intravenous infusion 20% Mannitol ,200 ml, q8H, two times.
    ARM 1: Kind: Experimental
    Label: Intravenous HUCB Monocyte
    Description: 1. Stroke patients are received Intravenous implantation of human cord blood stem cells , 2. Continued to provide Antiplatelet Medication( warfarin or Aspirin ), and Rehabilitation.
  • Human Umbilical Cord Blood mononuclear cells and 20% mannitol Other
    Intervention Desc: The cord blood need to be infusion within 72 hours after the onset of stroke, and the cord blood mononuclear cells 200 million ~ 500 million will used. 20% mannitol 200 ml iv for 30±10 min/q8h±2h will be administered twice after cord blood infusion .
    ARM 1: Kind: Experimental
    Label: HUCB cells combine with Mannitol treatment in acute stroke
    Description: The cord blood need to be infusion within 72 hours after the onset of stroke, and the cord blood mononuclear cells 200 million ~ 500 million will used. 20% mannitol 200 ml iv for 30±10 min/q8h±2h will be administered twice after cord blood infusion .

Trial Design

  • 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 24 hours Yes
Secondary Change from baseline in Brain Image Change from baseline in Brain Image at 24 hours Yes
Secondary Change from baseline in spleen sonography Change from baseline in spleen sonography at 3 month Yes
Primary Number of Adverse Events after in fusion 24, 48, 72 hours , 1 week, and 1, 3, 6 , 9, 12 months. Yes
Secondary Brain Image(MRI) baseline, after infusion 24 hours, 1, 6, 12months Yes
Secondary abdominal sonography-spleen baseline, after infusion 24, 72 hours, 3, 12months No
Secondary NIHSS baseline, after infusion 24, 48, 72 hours, 1weeks or discharge, 1 3, 6, 9, 12months Yes
Secondary Berg Balance score baseline, after infusion 24, 48, 72 hours, 1weeks or discharge, 1 3, 6, 9, 12months Yes
Secondary Barthel Index baseline, after infusion 24, 48, 72 hours, 1weeks or discharge, 1 3, 6, 9, 12months Yes
Secondary Blood examination baseline, after infusion 24, 48, 72 hours, 1 3, 6, 9, 12months Yes
Secondary cytokine family baseline, after infusion 24, 48, 72 hours, 1 3, 6, 9, 12months No
Primary adverse events (AE)and serious adverse reaction(SAE) after infusion 24, 48, 72 hours , 1 week or discharge , and 1, 3, 6 , 9, 12 months. Yes

Sponsors