Autologous Bone Marrow Mononuclear Cell Transplantation for Stroke Patients

This study has been completed.
Sponsor:
Collaborator:
Institute of Biomedical Research and Innovation, Kobe,Hyogo, Japan
Information provided by (Responsible Party):
Akihiko Taguchi, National Cerebral and Cardiovascular Center
ClinicalTrials.gov Identifier:
NCT01028794
First received: December 8, 2009
Last updated: July 4, 2013
Last verified: July 2013
  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 ]

Enrollment: 12
Study Start Date: May 2008
Study Completion Date: July 2013
Primary Completion Date: July 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Japan
Department of Cerebrovascular Disease, National Cardiovascular Center
Suita, Osaka, Japan, 565-8565
Sponsors and Collaborators
National Cerebral and Cardiovascular Center
Institute of Biomedical Research and Innovation, Kobe,Hyogo, Japan
Investigators
Principal Investigator: Akihiko Taguchi, MD.PhD Department of Cerebrovascular Disease, National Cardiovascular Center
  More Information

Publications:
Responsible Party: Akihiko Taguchi, guest investigator, National Cerebral and Cardiovascular Center
ClinicalTrials.gov Identifier: NCT01028794     History of Changes
Other Study ID Numbers: UMIN000001133, UMIN000001133
Study First Received: December 8, 2009
Last Updated: July 4, 2013
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:
Stroke
Cerebral Infarction
Embolism
Intracranial Embolism
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Embolism and Thrombosis
Intracranial Embolism and Thrombosis
Thromboembolism
Thrombosis

ClinicalTrials.gov processed this record on October 19, 2014