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Completed

NCT Number: NCT01028794

Autologous Bone Marrow Mononuclear Cell Transplantation for Stroke Patients

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.

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Key information

Conditions

Cerebral Embolism Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Embolism and Thrombosis Intracranial Embolism Intracranial Embolism and Thrombosis Nervous System Diseases Stroke Thromboembolism Vascular Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Department of Cerebrovascular Disease, National Cardiovascular Center

Suita, Osaka, 565-8565, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

autologous bone marrow mononuclear cells

Biological

intravenous administration of autologous bone marrow derived mononuclear cells obtained from 25ml of bone marrow on day 7-10 after stroke (only once in that period)

Primary outcomes

  1. Improvement of NIHSS（National Institute of Health Stroke Scale）

    Time frame: 30 days after treatment

  2. Frequency of change for the worse in NIHSS

    Time frame: 30 days aftrer treatment

Secondary outcomes

  1. Mean level of mRS (modified Rankin Scale)

    Time frame: 30 days after treatment

  2. Frequency of death

    Time frame: day 30 after treatment

Sponsors and collaborators

Lead sponsor

National Cerebral and Cardiovascular Center, Japan

Other

Collaborators

  • Institute of Biomedical Research and Innovation, Kobe, Hyogo, Japan

Registry information

Official study title

Phase 1/2A Study of Intravenous Autologous Bone Marrow Mononuclear Cell Transplantation for Patients After Cerebral Embolism

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Dec 9, 2009
Registry last updated
Jul 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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