Autologous Bone Marrow Mononuclear Cell Transplantation for Stroke Patients

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01028794
• Other study ID #: UMIN000001133
• Secondary ID: UMIN000001133
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 8, 2009
• Last updated: July 4, 2013
• Start date: May 2008
• Est. completion date: July 2013

Study information

• Verified date: July 2013
• Source: National Cerebral and Cardiovascular Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cerebral Embolism
• Embolism
• Intracranial Embolism
• Stroke

Intervention

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)
• 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)

Locations

Country	Name	City	State
Japan	Department of Cerebrovascular Disease, National Cardiovascular Center	Suita	Osaka

Sponsors (2)

Lead Sponsor	Collaborator
National Cerebral and Cardiovascular Center	Institute of Biomedical Research and Innovation, Kobe,Hyogo, Japan

Country where clinical trial is conducted

Japan, 

References & Publications (4)

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. Epub 2004 Jun 7. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of NIHSS(National Institute of Health Stroke Scale)		30 days after treatment	No
Primary	Frequency of change for the worse in NIHSS		30 days aftrer treatment	Yes
Secondary	Mean level of mRS (modified Rankin Scale)		30 days after treatment	No
Secondary	Frequency of death		day 30 after treatment	Yes