Autologous Cell Therapy After Stroke

Withdrawn

Phase 1 Results N/A

Trial Description

This study will examine the safety of two different cellular therapies in the treatment of stroke.

Detailed Description

Stroke remains a leading cause of death and disability. A limited number of therapies, such as intravenous tissue plasminogen activator, have been approved to interrupt stroke in the early hours after symptom onset. Many patients are not able to benefit from these therapies, however, and so a need exists for development of new interventions to reduce disability after stroke. This study will be an early step towards this, and will examine the safety of two cell types, mononuclear cells and marrow stromal cells. In each case, the cells will be autologous, specifically being derived from the subject's own bone marrow.

Trial Stopped: Not funded

Conditions

Interventions

  • Saline Drug
    Other Names: Sodium Chloride
    Intervention Desc: Used as placebo for injection.
  • Placebo Drug
    Intervention Desc: a single intravenous transfusion of saline, approximately 2-21 days after bone marrow aspiration, and 4-23 days after stroke onset; the full amount of mononuclear cells derived from 30 cc of bone marrow
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: Placebo
  • Autologous bone marrow mononuclear cell transfusion Biological
    Other Names: mononuclear cells
    Intervention Desc: a single intravenous transfusion approximately 2 days after bone marrow aspiration, and 4 days after stroke onset; the full amount of autologous mononuclear cells derived from 30 cc of bone marrow
    ARM 1: Kind: Experimental
    Label: autologous mononuclear cells
    Description: a single intravenous autologous bone marrow mononuclear cell transfusion
  • Autologous marrow stromal cell transfusion Procedure/Surgery
    Intervention Desc: the full amount of marrow stromal cells cultured over 21 days from 30 cc of bone marrow (expected to be approximately 1,000,000 cells/kg body weight)
  • Marrow stromal cells Biological
    Other Names: mesenchymal stromal cells
    Intervention Desc: a single intravenous transfusion approximately 21 days after bone marrow aspiration, and 23 days after stroke onset; the full amount of marrow stromal cells cultured over 21 days from 30 cc of bone marrow (expected to be approximately 1,000,000 cells/kg body weight)
    ARM 1: Kind: Experimental
    Label: autologous marrow stromal cells
    Description: a single intravenous autologous marrow stromal cell transfusion

Trial Design

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

Patient Involvement

Patient will undergo NIHSS and bone marrow aspiration after enrollment in study. They will then be randomized to one of three arms: 1) a single intravenous transfusion of saline, approximately 2-21 days after bone marrow aspiration, and 4-23 days after stroke onset; the full amount of mononuclear cells derived from 30 cc of bone marrow; 2) a single intravenous transfusion approximately 2 days after bone marrow aspiration, and 4 days after stroke onset; the full amount of autologous mononuclear cells derived from 30 cc of bone marrow; or 3) a single intravenous transfusion approximately 21 days after bone marrow aspiration, and 23 days after stroke onset; the full amount of marrow stromal cells cultured over 21 days from 30 cc of bone marrow (expected to be approximately 1,000,000 cells/kg body weight). All will receive standard physical, occupational and speech rehabilitation therapy for post-stroke. Then be evaluated for outcome at 90 days post-stroke.

Outcomes

Type Measure Time Frame Safety Issue
Secondary Myocardial infarction, pulmonary embolism, ischemic stroke, deep venous thrombosis, other arterial or venous thrombosis, infection requiring IV antibiotics.
Primary death 90 days after stroke onset Yes
Secondary myocardial infarction 90 days after stroke onset Yes
Secondary pulmonary embolism 90 days after stroke onset Yes
Secondary ischemic stroke 90 days after stroke onset Yes
Secondary deep venous thrombosis 90 days after stroke onset Yes
Secondary other arterial or venous thrombosis 90 days after stroke onset Yes
Secondary Infection requiring IV antibiotics 90 days after stroke onset Yes

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