Autologous Bone Marrow Mononuclear Cell Transplantation for Stroke Patients

National Cerebral and Cardiovascular Center, Japan

Status and phase: Completed; Phase 2; Phase 1

Conditions: Stroke; Cerebral Embolism

Treatments: Biological: autologous bone marrow mononuclear cells

Study type: Interventional

Funder types: Other

Identifiers

NCT01028794

UMIN000001133 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to determine whether autologous bone marrow mononuclear cells transplantation after stroke is safe and/or effective to improve neurological outcome.

Enrollment: 12 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with cerebral embolism.
• NIHSS score is more than (or equal to) 10.
• On day 7 after onset of stroke, the improvement of NIHSS is less than (or equal to) 5, compared with the level at administration.
• Bone marrow aspiration can be done in 10 days after onset of stroke

Exclusion criteria

• Patient with cerebral hemorrhage or symptomatic hemorrhagic infarction.
• Patient who expects brain surgery.
• Patient with acute myocardial infarction.
• Patient with coagulation disorder.
• Number of Platelet < 100000/mm3
• Serum creatinine level >2.0mg/dl
• Patient with malignancy.
• Patient with uncontrolled proliferative diabetic retinopathy.
• Patient suspected infective endocarditis.
• HBV, HCV, HIV or HTLV positive

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

autologous bone marrow mononuclear cell

Experimental group

Description:

On day 7-10 after stroke, patient has 25ml of bone marrow cells aspiration. Mononuclear cells are purified by Ficoll and administrated intravenously.

Treatment:

Biological: autologous bone marrow mononuclear cells

Biological: autologous bone marrow mononuclear cells

autologous bone marrow mononuclear cells

Experimental group

Description:

On day 7-10 after stroke, patient has 50ml of bone marrow cells aspiration. Mononuclear cells are purified by Ficoll and administrated intravenously.

Treatment:

Biological: autologous bone marrow mononuclear cells

Biological: autologous bone marrow mononuclear cells