Study to Determine The Effect of a Drug Called Neupogen on Stroke Recovery "GIST"

Active, not recruiting

Phase 1 Results N/A

Trial Description

1. Circulating bone marrow and blood vessel precursors home in to sites of ischemia and aid regeneration of injured tissue
2. Increasing the number of circulating precursors will improve in regeneration of damaged brain following ischemic stroke.

Detailed Description

We hypothesize that mobilization of bone marrow precursor cells into the blood stream will allow them to redistribute in the injured central nervous system and aid regeneration of damaged tissue. If the hypotheses is correct, it predicts that G-CSF treatment will improve the functional outcome of patients following acute ischemic stroke.
Underlying this work are the following considerations:
- Currently the clinical and functional outcomes following ischemic strokes are poor and require new treatment strategies.
- G-CSF administration is a well established routine treatment for the mobilization of hematopoietic and endothelial precursors from the bone marrow into the circulation.
- Acute ischemia locally increases factors that direct circulating bone marrow derived cells to home to these sites of injury.
- Evidence exists that bone marrow derived cells are able to repopulate different tissues including those of the CNS.
- Acute ischemic injury to the central nervous system provides a milieu for the regeneration of neural tissue.

Conditions

Interventions

  • Filgrastim Drug
    Other Names: Leukostim
    Intervention Desc: 10 ug/kg sc once daily x 4 days. Repeated once, 6 weeks later.
    ARM 1: Kind: Experimental
    Label: Normal Saline
    ARM 2: Kind: Experimental
    Label: Filgrastim

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary A statistically significant increase in: mortality/ non-fatal grade III or greater adverse events measured by the NCI Common Toxicity Scale/ incidence of recurrent strokes/ worsening of neurological disabilities measured by standardized stroke scales. 6 weeks, 3 months, 6 months and 12 months after the first dose of the study drug. Yes
Secondary The secondary endpoints address the feasibility and efficacy of the study treatment: adequacy of bone marrow cell mobilization/ validation of imaging sequences/ Identification of optimal parameters for follow-up to be used in a subsequent larger trial. 6 weeks, 3 months, 6 months and 12 months after the first dose of the study drug. No

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