Autologous Cell Therapy After Stroke

University of California Irvine (UCI)

Status and phase: Withdrawn; Phase 1

Conditions: Stroke

Treatments: Drug: placebo; Biological: autologous bone marrow mononuclear cell transfusion; Biological: marrow stromal cells

Study type: Interventional

Funder types: Other

Identifiers

NCT00908856

2003-3040

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

0 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: placebo

autologous mononuclear cells

Active Comparator group

Description:

a single intravenous autologous bone marrow mononuclear cell transfusion

Treatment:

Biological: autologous bone marrow mononuclear cell transfusion

autologous marrow stromal cells

Active Comparator group

Description:

a single intravenous autologous marrow stromal cell transfusion

Treatment:

Biological: marrow stromal cells