Autologous Cell Therapy After Stroke

NCT ID: NCT00908856

Last Updated: 2016-02-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-12-31

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

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

autologous mononuclear cells

a single intravenous autologous bone marrow mononuclear cell transfusion

Group Type: ACTIVE_COMPARATOR

autologous bone marrow mononuclear cell transfusion

Intervention Type: BIOLOGICAL

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

autologous marrow stromal cells

a single intravenous autologous marrow stromal cell transfusion

Group Type: ACTIVE_COMPARATOR

marrow stromal cells

Intervention Type: BIOLOGICAL

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)

Interventions

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

Intervention Type: 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)

Intervention Type: BIOLOGICAL

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

Intervention Type: DRUG

Other Intervention Names

mononuclear cells; mesenchymal stromal cells

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Diego

OTHER

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Steven C. Cramer, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven C. Cramer, MD, MMSc

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

UC Irvine Medical Center

Orange, California, United States

Countries

United States

References

Lane TA, Garls D, Mackintosh E, Kohli S, Cramer SC. Liquid storage of marrow stromal cells. Transfusion. 2009 Jul;49(7):1471-81. doi: 10.1111/j.1537-2995.2009.02138.x. Epub 2009 Mar 31.

Reference Type: BACKGROUND

PMID: 19389020 (View on PubMed)

Other Identifiers

2003-3040

Identifier Type: -

Identifier Source: org_study_id