Intra-Arterial Bone Marrow Mononuclear Cells in Ischemic Stroke A Pilot Clinical Trial
Bone marrow mononuclear cell (BM-MNC) intra-arterial transplantation improves recovery in experimental models of ischemic stroke. We aimed to assess the safety, feasibility, and biological effects of autologous BM-MNC transplantation in patients with stroke. A single-blind (outcomes assessor) contro...
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| Published in | Stroke (1970) Vol. 43; no. 8; pp. 2242 - 2244 |
|---|---|
| Main Authors | , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Hagerstown, MD
Lippincott Williams & Wilkins
01.08.2012
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| Subjects | |
| Online Access | Get full text |
| ISSN | 0039-2499 1524-4628 1524-4628 |
| DOI | 10.1161/STROKEAHA.112.659409 |
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| Abstract | Bone marrow mononuclear cell (BM-MNC) intra-arterial transplantation improves recovery in experimental models of ischemic stroke. We aimed to assess the safety, feasibility, and biological effects of autologous BM-MNC transplantation in patients with stroke.
A single-blind (outcomes assessor) controlled Phase I/II trial was conducted in patients with middle cerebral artery stroke. Autologous BM-MNCs were injected intra-arterially between 5 and 9 days after stroke. Follow-up was done for up to 6 months and blood samples were collected for biological markers. The primary outcome was safety and feasibility of the procedure. The secondary outcome was improvement in neurological function.
Ten cases (BM-MNC-treated) and 10 control subjects (BM-MNC-nontreated) were consecutively included. Mean National Institutes of Health Stroke Scale before the procedure was 15.6. Mean BM-MNCs injected were 1.59×10(8). There was no death, stroke recurrence, or tumor formation during follow-up, although 2 cases had an isolate partial seizure at 3 months. After transplantation, higher plasma levels of beta nerve growth factor (β-nerve growth factor) were found compared with control subjects (P=0.02). There were no significant differences in neurological function at 180 days. A trend to positive correlation between number of CD34+ cells injected and Barthel Index was found (r=0.56, P=0.09).
Intra-arterial BM-MNC transplantation in subacute ischemic stroke is feasible and seems to be safe. Larger randomized trials are needed to confirm the safety and elucidate the efficacy of BM-MNC transplantation.
www.clinicaltrials.gov. Unique identifier: NCT00761982. |
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| AbstractList | Bone marrow mononuclear cell (BM-MNC) intra-arterial transplantation improves recovery in experimental models of ischemic stroke. We aimed to assess the safety, feasibility, and biological effects of autologous BM-MNC transplantation in patients with stroke.BACKGROUND AND PURPOSEBone marrow mononuclear cell (BM-MNC) intra-arterial transplantation improves recovery in experimental models of ischemic stroke. We aimed to assess the safety, feasibility, and biological effects of autologous BM-MNC transplantation in patients with stroke.A single-blind (outcomes assessor) controlled Phase I/II trial was conducted in patients with middle cerebral artery stroke. Autologous BM-MNCs were injected intra-arterially between 5 and 9 days after stroke. Follow-up was done for up to 6 months and blood samples were collected for biological markers. The primary outcome was safety and feasibility of the procedure. The secondary outcome was improvement in neurological function.METHODSA single-blind (outcomes assessor) controlled Phase I/II trial was conducted in patients with middle cerebral artery stroke. Autologous BM-MNCs were injected intra-arterially between 5 and 9 days after stroke. Follow-up was done for up to 6 months and blood samples were collected for biological markers. The primary outcome was safety and feasibility of the procedure. The secondary outcome was improvement in neurological function.Ten cases (BM-MNC-treated) and 10 control subjects (BM-MNC-nontreated) were consecutively included. Mean National Institutes of Health Stroke Scale before the procedure was 15.6. Mean BM-MNCs injected were 1.59×10(8). There was no death, stroke recurrence, or tumor formation during follow-up, although 2 cases had an isolate partial seizure at 3 months. After transplantation, higher plasma levels of beta nerve growth factor (β-nerve growth factor) were found compared with control subjects (P=0.02). There were no significant differences in neurological function at 180 days. A trend to positive correlation between number of CD34+ cells injected and Barthel Index was found (r=0.56, P=0.09).RESULTSTen cases (BM-MNC-treated) and 10 control subjects (BM-MNC-nontreated) were consecutively included. Mean National Institutes of Health Stroke Scale before the procedure was 15.6. Mean BM-MNCs injected were 1.59×10(8). There was no death, stroke recurrence, or tumor formation during follow-up, although 2 cases had an isolate partial seizure at 3 months. After transplantation, higher plasma levels of beta nerve growth factor (β-nerve growth factor) were found compared with control subjects (P=0.02). There were no significant differences in neurological function at 180 days. A trend to positive correlation between number of CD34+ cells injected and Barthel Index was found (r=0.56, P=0.09).Intra-arterial BM-MNC transplantation in subacute ischemic stroke is feasible and seems to be safe. Larger randomized trials are needed to confirm the safety and elucidate the efficacy of BM-MNC transplantation.CONCLUSIONSIntra-arterial BM-MNC transplantation in subacute ischemic stroke is feasible and seems to be safe. Larger randomized trials are needed to confirm the safety and elucidate the efficacy of BM-MNC transplantation.www.clinicaltrials.gov. Unique identifier: NCT00761982.CLINICAL TRIAL REGISTRATION URLwww.clinicaltrials.gov. Unique identifier: NCT00761982. Bone marrow mononuclear cell (BM-MNC) intra-arterial transplantation improves recovery in experimental models of ischemic stroke. We aimed to assess the safety, feasibility, and biological effects of autologous BM-MNC transplantation in patients with stroke. A single-blind (outcomes assessor) controlled Phase I/II trial was conducted in patients with middle cerebral artery stroke. Autologous BM-MNCs were injected intra-arterially between 5 and 9 days after stroke. Follow-up was done for up to 6 months and blood samples were collected for biological markers. The primary outcome was safety and feasibility of the procedure. The secondary outcome was improvement in neurological function. Ten cases (BM-MNC-treated) and 10 control subjects (BM-MNC-nontreated) were consecutively included. Mean National Institutes of Health Stroke Scale before the procedure was 15.6. Mean BM-MNCs injected were 1.59×10(8). There was no death, stroke recurrence, or tumor formation during follow-up, although 2 cases had an isolate partial seizure at 3 months. After transplantation, higher plasma levels of beta nerve growth factor (β-nerve growth factor) were found compared with control subjects (P=0.02). There were no significant differences in neurological function at 180 days. A trend to positive correlation between number of CD34+ cells injected and Barthel Index was found (r=0.56, P=0.09). Intra-arterial BM-MNC transplantation in subacute ischemic stroke is feasible and seems to be safe. Larger randomized trials are needed to confirm the safety and elucidate the efficacy of BM-MNC transplantation. www.clinicaltrials.gov. Unique identifier: NCT00761982. |
| Author | Boada, Cristina Espigado, Ildefonso Garcia-Solis, David Rosell, Anna Gil-Peralta, Alberto Montaner, Joan Jimenez, Maria-Dolores Moniche, Francisco Piñero, Pilar Cayuela, Aurelio Gonzalez, Alejandro Gonzalez-Marcos, Jose-Ramon Mayol, Antonio Carmona, Magdalena |
| Author_xml | – sequence: 1 givenname: Francisco surname: Moniche fullname: Moniche, Francisco organization: From the Departments of Neurology (F.M., J.-R.G.-M., M.D.J., A.G.P.), Radiology (A.G., P.P., D.G.S., A.M.), and Hematology (M.C., I.E.), and Clinical Research Services (A.C.), Hospital Universitario Virgen del Roc|f8o, Seville, Spain; and the Neurovascular Research Laboratory, Institut de Recerca Vall d'Hebron, Hospital Vall d'Hebron, Barcelona, Spain (J.M., C.B., A.R.) – sequence: 2 givenname: Alejandro surname: Gonzalez fullname: Gonzalez, Alejandro organization: From the Departments of Neurology (F.M., J.-R.G.-M., M.D.J., A.G.P.), Radiology (A.G., P.P., D.G.S., A.M.), and Hematology (M.C., I.E.), and Clinical Research Services (A.C.), Hospital Universitario Virgen del Roc|f8o, Seville, Spain; and the Neurovascular Research Laboratory, Institut de Recerca Vall d'Hebron, Hospital Vall d'Hebron, Barcelona, Spain (J.M., C.B., A.R.) – sequence: 3 givenname: Jose-Ramon surname: Gonzalez-Marcos fullname: Gonzalez-Marcos, Jose-Ramon organization: From the Departments of Neurology (F.M., J.-R.G.-M., M.D.J., A.G.P.), Radiology (A.G., P.P., D.G.S., A.M.), and Hematology (M.C., I.E.), and Clinical Research Services (A.C.), Hospital Universitario Virgen del Roc|f8o, Seville, Spain; and the Neurovascular Research Laboratory, Institut de Recerca Vall d'Hebron, Hospital Vall d'Hebron, Barcelona, Spain (J.M., C.B., A.R.) – sequence: 4 givenname: Magdalena surname: Carmona fullname: Carmona, Magdalena organization: From the Departments of Neurology (F.M., J.-R.G.-M., M.D.J., A.G.P.), Radiology (A.G., P.P., D.G.S., A.M.), and Hematology (M.C., I.E.), and Clinical Research Services (A.C.), Hospital Universitario Virgen del Roc|f8o, Seville, Spain; and the Neurovascular Research Laboratory, Institut de Recerca Vall d'Hebron, Hospital Vall d'Hebron, Barcelona, Spain (J.M., C.B., A.R.) – sequence: 5 givenname: Pilar surname: Piñero fullname: Piñero, Pilar organization: From the Departments of Neurology (F.M., J.-R.G.-M., M.D.J., A.G.P.), Radiology (A.G., P.P., D.G.S., A.M.), and Hematology (M.C., I.E.), and Clinical Research Services (A.C.), Hospital Universitario Virgen del Roc|f8o, Seville, Spain; and the Neurovascular Research Laboratory, Institut de Recerca Vall d'Hebron, Hospital Vall d'Hebron, Barcelona, Spain (J.M., C.B., A.R.) – sequence: 6 givenname: Ildefonso surname: Espigado fullname: Espigado, Ildefonso organization: From the Departments of Neurology (F.M., J.-R.G.-M., M.D.J., A.G.P.), Radiology (A.G., P.P., D.G.S., A.M.), and Hematology (M.C., I.E.), and Clinical Research Services (A.C.), Hospital Universitario Virgen del Roc|f8o, Seville, Spain; and the Neurovascular Research Laboratory, Institut de Recerca Vall d'Hebron, Hospital Vall d'Hebron, Barcelona, Spain (J.M., C.B., A.R.) – sequence: 7 givenname: David surname: Garcia-Solis fullname: Garcia-Solis, David organization: From the Departments of Neurology (F.M., J.-R.G.-M., M.D.J., A.G.P.), Radiology (A.G., P.P., D.G.S., A.M.), and Hematology (M.C., I.E.), and Clinical Research Services (A.C.), Hospital Universitario Virgen del Roc|f8o, Seville, Spain; and the Neurovascular Research Laboratory, Institut de Recerca Vall d'Hebron, Hospital Vall d'Hebron, Barcelona, Spain (J.M., C.B., A.R.) – sequence: 8 givenname: Aurelio surname: Cayuela fullname: Cayuela, Aurelio organization: From the Departments of Neurology (F.M., J.-R.G.-M., M.D.J., A.G.P.), Radiology (A.G., P.P., D.G.S., A.M.), and Hematology (M.C., I.E.), and Clinical Research Services (A.C.), Hospital Universitario Virgen del Roc|f8o, Seville, Spain; and the Neurovascular Research Laboratory, Institut de Recerca Vall d'Hebron, Hospital Vall d'Hebron, Barcelona, Spain (J.M., C.B., A.R.) – sequence: 9 givenname: Joan surname: Montaner fullname: Montaner, Joan organization: From the Departments of Neurology (F.M., J.-R.G.-M., M.D.J., A.G.P.), Radiology (A.G., P.P., D.G.S., A.M.), and Hematology (M.C., I.E.), and Clinical Research Services (A.C.), Hospital Universitario Virgen del Roc|f8o, Seville, Spain; and the Neurovascular Research Laboratory, Institut de Recerca Vall d'Hebron, Hospital Vall d'Hebron, Barcelona, Spain (J.M., C.B., A.R.) – sequence: 10 givenname: Cristina surname: Boada fullname: Boada, Cristina organization: From the Departments of Neurology (F.M., J.-R.G.-M., M.D.J., A.G.P.), Radiology (A.G., P.P., D.G.S., A.M.), and Hematology (M.C., I.E.), and Clinical Research Services (A.C.), Hospital Universitario Virgen del Roc|f8o, Seville, Spain; and the Neurovascular Research Laboratory, Institut de Recerca Vall d'Hebron, Hospital Vall d'Hebron, Barcelona, Spain (J.M., C.B., A.R.) – sequence: 11 givenname: Anna surname: Rosell fullname: Rosell, Anna organization: From the Departments of Neurology (F.M., J.-R.G.-M., M.D.J., A.G.P.), Radiology (A.G., P.P., D.G.S., A.M.), and Hematology (M.C., I.E.), and Clinical Research Services (A.C.), Hospital Universitario Virgen del Roc|f8o, Seville, Spain; and the Neurovascular Research Laboratory, Institut de Recerca Vall d'Hebron, Hospital Vall d'Hebron, Barcelona, Spain (J.M., C.B., A.R.) – sequence: 12 givenname: Maria-Dolores surname: Jimenez fullname: Jimenez, Maria-Dolores organization: From the Departments of Neurology (F.M., J.-R.G.-M., M.D.J., A.G.P.), Radiology (A.G., P.P., D.G.S., A.M.), and Hematology (M.C., I.E.), and Clinical Research Services (A.C.), Hospital Universitario Virgen del Roc|f8o, Seville, Spain; and the Neurovascular Research Laboratory, Institut de Recerca Vall d'Hebron, Hospital Vall d'Hebron, Barcelona, Spain (J.M., C.B., A.R.) – sequence: 13 givenname: Antonio surname: Mayol fullname: Mayol, Antonio organization: From the Departments of Neurology (F.M., J.-R.G.-M., M.D.J., A.G.P.), Radiology (A.G., P.P., D.G.S., A.M.), and Hematology (M.C., I.E.), and Clinical Research Services (A.C.), Hospital Universitario Virgen del Roc|f8o, Seville, Spain; and the Neurovascular Research Laboratory, Institut de Recerca Vall d'Hebron, Hospital Vall d'Hebron, Barcelona, Spain (J.M., C.B., A.R.) – sequence: 14 givenname: Alberto surname: Gil-Peralta fullname: Gil-Peralta, Alberto organization: From the Departments of Neurology (F.M., J.-R.G.-M., M.D.J., A.G.P.), Radiology (A.G., P.P., D.G.S., A.M.), and Hematology (M.C., I.E.), and Clinical Research Services (A.C.), Hospital Universitario Virgen del Roc|f8o, Seville, Spain; and the Neurovascular Research Laboratory, Institut de Recerca Vall d'Hebron, Hospital Vall d'Hebron, Barcelona, Spain (J.M., C.B., A.R.) |
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| Issue | 8 |
| Keywords | Cerebral infarction stem cells Stroke Nervous system diseases Cardiovascular disease Cerebral disorder Vascular disease cell transplantation Mononuclear cell Central nervous system disease Brain ischemia Bone marrow cerebral infarct Cerebrovascular disease |
| Language | English |
| License | CC BY 4.0 |
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| PublicationTitle | Stroke (1970) |
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| PublicationYear | 2012 |
| Publisher | Lippincott Williams & Wilkins |
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| Snippet | Bone marrow mononuclear cell (BM-MNC) intra-arterial transplantation improves recovery in experimental models of ischemic stroke. We aimed to assess the... |
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| SubjectTerms | Adolescent Adult Aged Aged, 80 and over Antigens, CD34 Biological and medical sciences Blood. Blood coagulation. Reticuloendothelial system Bone Marrow Transplantation - adverse effects Bone Marrow Transplantation - methods Brain Ischemia - therapy Female Granulocyte Colony-Stimulating Factor - blood Hemodynamics - physiology Humans Infarction, Middle Cerebral Artery - complications Infarction, Middle Cerebral Artery - therapy Male Medical sciences Middle Aged Nerve Growth Factor - blood Neurologic Examination Neurology Pharmacology. Drug treatments Pilot Projects Safety Stroke - therapy Treatment Outcome Vascular diseases and vascular malformations of the nervous system Young Adult |
| Subtitle | A Pilot Clinical Trial |
| Title | Intra-Arterial Bone Marrow Mononuclear Cells in Ischemic Stroke |
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