Autologous Bone Marrow Mononuclear Cell Transplantation for Stroke Patients
NCT ID: NCT01028794
Last Updated: 2013-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
12 participants
INTERVENTIONAL
2008-05-31
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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
On day 7-10 after stroke, patient has 50ml of bone marrow cells aspiration. Mononuclear cells are purified by Ficoll and administrated intravenously.
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* 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 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
20 Years
75 Years
ALL
No
Sponsors
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Institute of Biomedical Research and Innovation, Kobe, Hyogo, Japan
OTHER
National Cerebral and Cardiovascular Center, Japan
OTHER
Responsible Party
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Akihiko Taguchi
guest investigator
Principal Investigators
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Akihiko Taguchi, MD.PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Cerebrovascular Disease, National Cardiovascular Center
Locations
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Department of Cerebrovascular Disease, National Cardiovascular Center
Suita, Osaka, Japan
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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UMIN000001133
Identifier Type: OTHER
Identifier Source: secondary_id
UMIN000001133
Identifier Type: -
Identifier Source: org_study_id
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