Safety of Escalating Doses of Intravenous Bone Marrow-Derived Mesenchymal Stem Cells in Patients With a New Ischemic Stroke

Withdrawn

Phase 1/2 Results N/A

Trial Description

Stroke is a major cause of adult disability. Currently approved reperfusion therapies are provided to only a small percentage of patients in the U.S. New therapies are needed that improve outcome and that can be accessed by a majority of patients. Animal studies suggest that bone marrow-derived mesenchymal stem cells, administered intravenously days after a stroke, safely improve long-term behavioral outcome. A large human experience suggests the safety of allogeneic bone marrow-derived mesenchymal stem cells. The current study aims to assess the safety of this therapy in patients with recent ischemic stroke.

Trial Stopped: Study was never started

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: Placebo
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: Placebo
  • Bone marrow-derived mesenchymal stem cells Biological
    Intervention Desc: bone marrow-derived mesenchymal stem cells
    ARM 1: Kind: Experimental
    Label: mesenchymal stem cells
    Description: bone marrow-derived mesenchymal stem cells

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Number of Adverse Events 1 month after transfusion Yes

Sponsors