Autologous Bone Marrow Mononuclear Cell Transplantation for Stroke Patients

Phase 1

Completed

• Conditions: Cerebral Embolism; Stroke
• Interventions: Biological: autologous bone marrow mononuclear cells

• Registration Number: NCT01028794
• Lead Sponsor: National Cerebral and Cardiovascular Center, Japan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2009-12-08
• Study First Submitted QC: 2009-12-08
• Study First Posted: 2009-12-09
• Status Verified: 2013-07
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Last Update Submitted: 2013-07-04
• Last Update Posted: 2013-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
autologous bone marrow mononuclear cell	autologous bone marrow mononuclear cells	On day 7-10 after stroke, patient has 25ml of bone marrow cells aspiration. Mononuclear cells are purified by Ficoll and administrated intravenously.
autologous bone marrow mononuclear cells	autologous bone marrow mononuclear cells	On day 7-10 after stroke, patient has 50ml of bone marrow cells aspiration. Mononuclear cells are purified by Ficoll and administrated intravenously.

Primary Outcome Measures

Name	Time	Method
Improvement of NIHSS（National Institute of Health Stroke Scale）	30 days after treatment
Frequency of change for the worse in NIHSS	30 days aftrer treatment

Secondary Outcome Measures

Name	Time	Method
Mean level of mRS (modified Rankin Scale)	30 days after treatment
Frequency of death	day 30 after treatment

Trial Locations

Locations (1)

Department of Cerebrovascular Disease, National Cardiovascular Center; 🇯🇵 Suita, Osaka, Japan