NCT00908856

Autologous Cell Therapy After Stroke

Safety of IV Autologous Mononuclear Cells and Marrow Stromal Cells After Stroke

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of California, Irvine · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke

Interventions

Type	Name	Description
BIOLOGICAL	autologous bone marrow mononuclear cell transfusion	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
BIOLOGICAL	marrow stromal cells	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)
DRUG	placebo	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

Timeline

• Start date: 2016-01-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2009-05-27
• Last updated: 2016-02-04

Locations

1 site across 1 country: United States