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Autologous Bone Marrow Mononuclear Cell Transplantation for Stroke Patients

This study is currently recruiting participants.
Verified July 2011 by National Cerebral and Cardiovascular Center
Sponsor:
Collaborator:
Hyogo College of Medicine
Information provided by:
National Cerebral and Cardiovascular Center
ClinicalTrials.gov Identifier:
NCT01028794
First received: December 8, 2009
Last updated: July 21, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Cerebral Embolism
Stroke
 Biological: autologous bone marrow mononuclear cells
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1/2A Study of Intravenous Autologous Bone Marrow Mononuclear Cell Transplantation for Patients After Cerebral Embolism

Further study details as provided by National Cerebral and Cardiovascular Center:

Primary Outcome Measures:
  • Improvement of NIHSS（National Institute of Health Stroke Scale） [ Time Frame: 30 days after treatment ] [ Designated as safety issue: No ]
  • Frequency of change for the worse in NIHSS [ Time Frame: 30 days aftrer treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Mean level of mRS (modified Rankin Scale) [ Time Frame: 30 days after treatment ] [ Designated as safety issue: No ]
  • Frequency of death [ Time Frame: day 30 after treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 12
Study Start Date: May 2008
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: autologous bone marrow mononuclear cell
On day 7-10 after stroke, patient has 25ml of bone marrow cells aspiration. Mononuclear cells are purified by Ficoll and administrated intravenously.
 Biological: autologous bone marrow mononuclear cells
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)
Experimental: 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.
 Biological: autologous bone marrow mononuclear cells
intravenous administration of autologous bone marrow derived mononuclear cells obtained from 50ml of bone marrow on day 7-10 after stroke (only once in that period)

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01028794

Contacts
Contact: Akihiko Taguchi, MD. PhD +81-6-6833-5012 ext 8373 taguchi@ri.ncvc.go.jp
Contact: Kazuyuki Nagatsuka, MD. PhD +81-6-6833-5012 ext 8093 nagatuka@hsp.ncvc.go.jp

Locations
Japan
Department of Cerebrovascular Disease, National Cardiovascular Center Recruiting
Suita, Osaka, Japan, 565-8565
Contact: Nobuyuki Asano     +81-6-6833-5012 ext 2246     nasano@mgt.ncvc.go.jp    
Sponsors and Collaborators
National Cerebral and Cardiovascular Center
Hyogo College of Medicine
Investigators
Principal Investigator: Akihiko Taguchi, MD.PhD Department of Cerebrovascular Disease, National Cardiovascular Center
  More Information

Publications:

Responsible Party: Akihiko Taguchi / chief of laboratory, Department of Cerebrovascular Disease, National Cardiovascular Center
ClinicalTrials.gov Identifier: NCT01028794     History of Changes
Other Study ID Numbers: UMIN000001133, UMIN000001133
Study First Received: December 8, 2009
Last Updated: July 21, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by National Cerebral and Cardiovascular Center:
stroke
bone marrow
mononuclear cell
angiogenesis
neurogenesis

Additional relevant MeSH terms:
Intracranial Embolism
Embolism
Stroke
Cerebral Infarction
Intracranial Embolism and Thrombosis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Thromboembolism
Embolism and Thrombosis
Thrombosis
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on May 16, 2013