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

Tracking Information

First Received Date ^ICMJE

December 8, 2009

Last Updated Date

July 21, 2011

Start Date ^ICMJE

May 2008

Estimated Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01028794 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Autologous Bone Marrow Mononuclear Cell Transplantation for Stroke Patients

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Cerebral Embolism
Stroke

Intervention ^ICMJE

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)

Study Arm (s)

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

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Not Provided

Estimated Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT01028794

Other Study ID Numbers ^ICMJE

UMIN000001133, UMIN000001133

Has Data Monitoring Committee

Yes

Responsible Party

Akihiko Taguchi / chief of laboratory, Department of Cerebrovascular Disease, National Cardiovascular Center

Study Sponsor ^ICMJE

National Cerebral and Cardiovascular Center

Collaborators ^ICMJE

Hyogo College of Medicine

Investigators ^ICMJE

Principal Investigator:

Akihiko Taguchi, MD.PhD

Department of Cerebrovascular Disease, National Cardiovascular Center

Information Provided By

National Cerebral and Cardiovascular Center

Verification Date

July 2011

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

To Top