Autologous Cell Therapy After Stroke

Phase 1

Withdrawn

• Conditions: Stroke
• Interventions: Drug: placebo; Biological: autologous bone marrow mononuclear cell transfusion; Biological: marrow stromal cells

• Registration Number: NCT00908856
• Lead Sponsor: University of California, Irvine

Brief Summary

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.

Study Timeline

• Study First Submitted: 2009-05-26
• Study First Submitted QC: 2009-05-26
• Study First Posted: 2009-05-27
• Study Start: 2016-01
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-02
• Last Update Posted: 2016-02-04
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Ischemic stroke that is supratentorial in location and < 72 hours old between stroke onset and bone marrow aspiration
• No major pre-stroke disability
• NIH stroke scale score of 7-24
• Able to undergo bedside bone marrow aspiration
• Age 18-85 years, inclusive
• Reasonable likelihood of receiving standard physical, occupational and speech rehabilitation therapy

Exclusion Criteria

• No major active hematological, immunological, or oncological diagnoses
• Pregnancy
• Lactating mothers
• At least 24 hours time of any thrombolytic therapy and time of bone marrow aspiration
• Allergy to penicillin or to fetal bovine serum
• Active, major co-existent neurological or psychiatric disease
• Infection with HIV, hepatitis B or C, or syphilis
• Any diagnosis that makes survival to 90 days post-stroke unlikely
• Participation in an experimental therapeutic clinical trial in the prior three months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	Placebo
autologous mononuclear cells	autologous bone marrow mononuclear cell transfusion	a single intravenous autologous bone marrow mononuclear cell transfusion
autologous marrow stromal cells	marrow stromal cells	a single intravenous autologous marrow stromal cell transfusion

Primary Outcome Measures

Name	Time	Method
death	90 days after stroke onset

Secondary Outcome Measures

Name	Time	Method
other arterial or venous thrombosis	90 days after stroke onset
pulmonary embolism	90 days after stroke onset
deep venous thrombosis	90 days after stroke onset
myocardial infarction	90 days after stroke onset
Infection requiring IV antibiotics	90 days after stroke onset
ischemic stroke	90 days after stroke onset

Trial Locations

Locations (1)

UC Irvine Medical Center; 🇺🇸 Orange, California, United States