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

December 8, 2009
July 4, 2013
May 2008
July 2013   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01028794 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Autologous Bone Marrow Mononuclear Cell Transplantation for Stroke Patients
Phase 1/2A Study of Intravenous Autologous Bone Marrow Mononuclear Cell Transplantation for Patients After Cerebral Embolism

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cerebral Embolism
  • Stroke
  • 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)
  • 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)
  • 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.
    Intervention: Biological: autologous bone marrow mononuclear cells
  • 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.
    Intervention: Biological: autologous bone marrow mononuclear cells

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
July 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01028794
UMIN000001133, UMIN000001133
Yes
Akihiko Taguchi, National Cerebral and Cardiovascular Center
National Cerebral and Cardiovascular Center
Institute of Biomedical Research and Innovation, Kobe,Hyogo, Japan
Principal Investigator: Akihiko Taguchi, MD.PhD Department of Cerebrovascular Disease, National Cardiovascular Center
National Cerebral and Cardiovascular Center
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP