Clinical trial NCT01028794: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cerebral Embolism
Stroke
Keywords: stroke
bone marrow
mononuclear cell
angiogenesis
neurogenesis
Lead sponsor: National Cerebral and Cardiovascular Center, Japan
Sponsor class: OTHER
Collaborators: name: Institute of Biomedical Research and Innovation, Kobe, Hyogo, Japan
First posted: 2009-12-09
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Improvement of NIHSS（National Institute of Health Stroke Scale）
timeFrame: 30 days after treatment
measure: Frequency of change for the worse in NIHSS
timeFrame: 30 days aftrer treatment
Secondary outcomes:
measure: Mean level of mRS (modified Rankin Scale)
timeFrame: 30 days after treatment
measure: Frequency of death
timeFrame: day 30 after treatment
Other outcomes:
Locations:
city: Suita
country: Japan
facility: Department of Cerebrovascular Disease, National Cardiovascular Center
state: Osaka
Study officials:
affiliation: Department of Cerebrovascular Disease, National Cardiovascular Center
name: Akihiko Taguchi, MD.PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.