Autologous Cell Therapy After Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00908856
• Other study ID #: 2003-3040
• Status: Withdrawn
• Phase: Phase 1
• First received: May 26, 2009
• Last updated: February 2, 2016
• Start date: January 2016
• Est. completion date: December 2017

Study information

• Verified date: February 2016
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Stroke

Intervention

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
• 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

Locations

Country	Name	City	State
United States	UC Irvine Medical Center	Orange	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Irvine	University of California, San Diego

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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