Intravenous autologous bone marrow mononuclear cell transplantation for cerebral embolism

UMIN ID: UMIN000001133

Registered date:01/05/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: cerebral embolism
• Date of first enrollment: 2008/05/01
• Target sample size: 12
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Low dose: Bone marrow 25ml On day 7-10 after stroke, patient has 25ml of bone marrow cells aspiration (only once per patient). Mononuclear cells are purified by Ficoll and administrated intravenously.
High dose: Bone marrow 50ml On day 7-10 after stroke, patient has 50ml of bone marrow cells aspiration (only once per patient). Mononuclear cells are purified by Ficoll and administrated intravenously.

Outcome(s)

• Primary Outcome: 1. Improvement of NIHSS (before vs 1 month after cell transplantation) 2. Frequency of change for the worse in NIHSS (before vs 1 month after cell transplantation)
• Secondary Outcome: 1. mRS (1, 3 and 6 months after cell transplantation) 2. Barthel Index (1, 3 and 6 months after cell transplantation) 3. NIHSS (1, 3 and 6 months after cell transplantation) 4. Ratio of mRS=0, 1, 2 or 3 at discharge 5. Frequency of hemorrhagic infarction (1 and 6 months after cell transplantation) 6. Frequency of death at discharge

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1. Patient with cerebral hemorrhage or symptomatic hemorrhagic infarction. 2. Patient who expects brain surgery. 3. Patient with acute myocardial infarction. 4. Patient with coagulation disorder. 5. Number of Platelet < 100000/mm3 6. Serum creatinine level >2.0mg/dl 7. Patient with malignancy. 8. Patient with uncontrolled proliferative diabetic retinopathy. 9. Patient suspected infective endocarditis. 10. HBV, HCV, HIV or HTLV positive.

Related Information

• Primary Sponsor: National Cerbral and Cardiovascular Center
• Secondary Sponsor: Institute of Biomedical Research and Innovation
• Source(s) of Monetary Support: Ministry of Health, Labour, and Welfare.
• Secondary ID(s): ClinicalTrials.gov Identifier: NCT01028794