search
Back to results

Autologous Bone Marrow Mononuclear Cell Transplantation for Stroke Patients

Primary Purpose

Cerebral Embolism, Stroke

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
autologous bone marrow mononuclear cells
autologous bone marrow mononuclear cells
Sponsored by
National Cerebral and Cardiovascular Center, Japan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Embolism focused on measuring stroke, bone marrow, mononuclear cell, angiogenesis, neurogenesis

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Cerebrovascular Disease, National Cardiovascular Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

autologous bone marrow mononuclear cell

autologous bone marrow mononuclear cells

Arm Description

On day 7-10 after stroke, patient has 25ml of bone marrow cells aspiration. Mononuclear cells are purified by Ficoll and administrated intravenously.

On day 7-10 after stroke, patient has 50ml of bone marrow cells aspiration. Mononuclear cells are purified by Ficoll and administrated intravenously.

Outcomes

Primary Outcome Measures

Improvement of NIHSS（National Institute of Health Stroke Scale）
Frequency of change for the worse in NIHSS

Secondary Outcome Measures

Mean level of mRS (modified Rankin Scale)
Frequency of death

Full Information

First Posted
December 8, 2009
Last Updated
July 4, 2013
Sponsor
National Cerebral and Cardiovascular Center, Japan
Collaborators
Institute of Biomedical Research and Innovation, Kobe, Hyogo, Japan
search

1. Study Identification

Unique Protocol Identification Number
NCT01028794
Brief Title
Autologous Bone Marrow Mononuclear Cell Transplantation for Stroke Patients
Official Title
Phase 1/2A Study of Intravenous Autologous Bone Marrow Mononuclear Cell Transplantation for Patients After Cerebral Embolism
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cerebral and Cardiovascular Center, Japan
Collaborators
Institute of Biomedical Research and Innovation, Kobe, Hyogo, Japan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Embolism, Stroke
Keywords
stroke, bone marrow, mononuclear cell, angiogenesis, neurogenesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
autologous bone marrow mononuclear cell
Arm Type
Experimental
Arm Description
On day 7-10 after stroke, patient has 25ml of bone marrow cells aspiration. Mononuclear cells are purified by Ficoll and administrated intravenously.
Arm Title
autologous bone marrow mononuclear cells
Arm Type
Experimental
Arm Description
On day 7-10 after stroke, patient has 50ml of bone marrow cells aspiration. Mononuclear cells are purified by Ficoll and administrated intravenously.
Intervention Type
Biological
Intervention Name(s)
autologous bone marrow mononuclear cells
Intervention Description
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)
Intervention Type
Biological
Intervention Name(s)
autologous bone marrow mononuclear cells
Intervention Description
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)
Primary Outcome Measure Information:
Title
Improvement of NIHSS（National Institute of Health Stroke Scale）
Time Frame
30 days after treatment
Title
Frequency of change for the worse in NIHSS
Time Frame
30 days aftrer treatment
Secondary Outcome Measure Information:
Title
Mean level of mRS (modified Rankin Scale)
Time Frame
30 days after treatment
Title
Frequency of death
Time Frame
day 30 after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Akihiko Taguchi, MD.PhD
Organizational Affiliation
Department of Cerebrovascular Disease, National Cardiovascular Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cerebrovascular Disease, National Cardiovascular Center
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-8565
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
15286799
Citation
Taguchi A, Soma T, Tanaka H, Kanda T, Nishimura H, Yoshikawa H, Tsukamoto Y, Iso H, Fujimori Y, Stern DM, Naritomi H, Matsuyama T. Administration of CD34+ cells after stroke enhances neurogenesis via angiogenesis in a mouse model. J Clin Invest. 2004 Aug;114(3):330-8. doi: 10.1172/JCI20622.
Results Reference
background
PubMed Identifier
12623341
Citation
Taguchi A, Ohtani M, Soma T, Watanabe M, Kinosita N. Therapeutic angiogenesis by autologous bone-marrow transplantation in a general hospital setting. Eur J Vasc Endovasc Surg. 2003 Mar;25(3):276-8. doi: 10.1053/ejvs.2002.1831. No abstract available.
Results Reference
background
PubMed Identifier
15184275
Citation
Taguchi A, Matsuyama T, Moriwaki H, Hayashi T, Hayashida K, Nagatsuka K, Todo K, Mori K, Stern DM, Soma T, Naritomi H. Circulating CD34-positive cells provide an index of cerebrovascular function. Circulation. 2004 Jun 22;109(24):2972-5. doi: 10.1161/01.CIR.0000133311.25587.DE. Epub 2004 Jun 7.
Results Reference
background
PubMed Identifier
17614944
Citation
Taguchi A, Wen Z, Myojin K, Yoshihara T, Nakagomi T, Nakayama D, Tanaka H, Soma T, Stern DM, Naritomi H, Matsuyama T. Granulocyte colony-stimulating factor has a negative effect on stroke outcome in a murine model. Eur J Neurosci. 2007 Jul;26(1):126-33. doi: 10.1111/j.1460-9568.2007.05640.x.
Results Reference
background

Learn more about this trial

Autologous Bone Marrow Mononuclear Cell Transplantation for Stroke Patients

We'll reach out to this number within 24 hrs