Increasing Dose of Autologous Bone Marrow Mononuclear Cells Transplantation Is Related to Stroke Outcome: Results from a Pooled Analysis of Two Clinical Trials
Background and Purpose. BM-MNC transplantation improves recovery in experimental models of ischemic stroke. Clinical trials are ongoing to test efficacy in stroke patients. However, whether cell dose is related to outcomes is not known. Methods. We performed a pooling data analysis of two pilot clin...
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| Format: | Article |
| Language: | English |
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Wiley
2016-01-01
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| Series: | Stem Cells International |
| Online Access: | http://dx.doi.org/10.1155/2016/8657173 |
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| author | Francisco Moniche Paulo Henrique Rosado-de-Castro Irene Escudero Elena Zapata Francisco Javier de la Torre Laviana Rosalia Mendez-Otero Magdalena Carmona Pilar Piñero Alejandro Bustamante Lucía Lebrato Juan Antonio Cabezas Alejandro Gonzalez Grabriel R. de Freitas Joan Montaner |
| author_facet | Francisco Moniche Paulo Henrique Rosado-de-Castro Irene Escudero Elena Zapata Francisco Javier de la Torre Laviana Rosalia Mendez-Otero Magdalena Carmona Pilar Piñero Alejandro Bustamante Lucía Lebrato Juan Antonio Cabezas Alejandro Gonzalez Grabriel R. de Freitas Joan Montaner |
| author_sort | Francisco Moniche |
| collection | DOAJ |
| description | Background and Purpose. BM-MNC transplantation improves recovery in experimental models of ischemic stroke. Clinical trials are ongoing to test efficacy in stroke patients. However, whether cell dose is related to outcomes is not known. Methods. We performed a pooling data analysis of two pilot clinical trials with autologous BM-MNCs transplantation in ischemic stroke patients. Cell dose and route were analyzed to evaluate their relation to good outcome (m-Rankin scale [mRS] score 0–2) at 6 months. Results. Twenty-two patients were included. A median of 153 × 106 (±121 × 106) BM-MNCs was injected. Intra-arterial route was used in 77.3% of cases. A higher number of cells injected were associated with better outcomes at 180 days (390 × 106 [320–422] BM-MNCs injected in those patients with mRS of 0–2 at 6 months versus 130 × 106 [89–210] in those patients with mRS 3–6, p=0.015). In the intra-arterially treated patients, a strong correlation between dose of cells and disability was found (r=-0.63, p=0.006). A cut point of 310 × 106 injected cells predicted good outcome with 80% sensitivity and 88.2% specificity. Conclusions. Similar to preclinical studies, a higher dose of autologous BM-MNC was related to better outcome in stroke patients, especially when more than 310 × 106 cells are injected. Further interventional studies are warranted to confirm these data. |
| format | Article |
| id | doaj-art-f69d6c8e82ba4821ad74c36952bbd0ba |
| institution | Kabale University |
| issn | 1687-966X 1687-9678 |
| language | English |
| publishDate | 2016-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Stem Cells International |
| spelling | doaj-art-f69d6c8e82ba4821ad74c36952bbd0ba2025-02-03T01:09:08ZengWileyStem Cells International1687-966X1687-96782016-01-01201610.1155/2016/86571738657173Increasing Dose of Autologous Bone Marrow Mononuclear Cells Transplantation Is Related to Stroke Outcome: Results from a Pooled Analysis of Two Clinical TrialsFrancisco Moniche0Paulo Henrique Rosado-de-Castro1Irene Escudero2Elena Zapata3Francisco Javier de la Torre Laviana4Rosalia Mendez-Otero5Magdalena Carmona6Pilar Piñero7Alejandro Bustamante8Lucía Lebrato9Juan Antonio Cabezas10Alejandro Gonzalez11Grabriel R. de Freitas12Joan Montaner13Department of Neurology, Hospital Universitario Virgen del Rocío, 41013 Seville, SpainInstituto de Ciências Biomédicas, Federal University of Rio de Janeiro, 21044-020 Rio de Janeiro, RJ, BrazilDepartment of Neurology, Hospital Universitario Virgen del Rocío, 41013 Seville, SpainDepartment of Neurology, Hospital Universitario Virgen del Rocío, 41013 Seville, SpainDepartment of Neurology, Hospital Universitario Virgen del Rocío, 41013 Seville, SpainInstituto de Biofísica Carlos Chagas Filho, Federal University of Rio de Janeiro, 21044-020 Rio de Janeiro, RJ, BrazilDepartment of Hematology, Hospital Universitario Virgen del Rocío, 41013 Seville, SpainDepartment of Radiology, Hospital Universitario Virgen del Rocío, 41013 Seville, SpainNeurovascular Research Laboratory, Institut de Recerca Vall d’Hebron, Hospital Vall d’Hebron, 08035 Barcelona, SpainDepartment of Neurology, Hospital Universitario Virgen del Rocío, 41013 Seville, SpainDepartment of Neurology, Hospital Universitario Virgen del Rocío, 41013 Seville, SpainDepartment of Radiology, Hospital Universitario Virgen del Rocío, 41013 Seville, SpainD’Or Institute for Research and Education, 22281-100 Rio de Janeiro, RJ, BrazilInstituto de Biomedicina de Sevilla-IBiS, Hospital Universitario Virgen del Rocío, 41013 Seville, SpainBackground and Purpose. BM-MNC transplantation improves recovery in experimental models of ischemic stroke. Clinical trials are ongoing to test efficacy in stroke patients. However, whether cell dose is related to outcomes is not known. Methods. We performed a pooling data analysis of two pilot clinical trials with autologous BM-MNCs transplantation in ischemic stroke patients. Cell dose and route were analyzed to evaluate their relation to good outcome (m-Rankin scale [mRS] score 0–2) at 6 months. Results. Twenty-two patients were included. A median of 153 × 106 (±121 × 106) BM-MNCs was injected. Intra-arterial route was used in 77.3% of cases. A higher number of cells injected were associated with better outcomes at 180 days (390 × 106 [320–422] BM-MNCs injected in those patients with mRS of 0–2 at 6 months versus 130 × 106 [89–210] in those patients with mRS 3–6, p=0.015). In the intra-arterially treated patients, a strong correlation between dose of cells and disability was found (r=-0.63, p=0.006). A cut point of 310 × 106 injected cells predicted good outcome with 80% sensitivity and 88.2% specificity. Conclusions. Similar to preclinical studies, a higher dose of autologous BM-MNC was related to better outcome in stroke patients, especially when more than 310 × 106 cells are injected. Further interventional studies are warranted to confirm these data.http://dx.doi.org/10.1155/2016/8657173 |
| spellingShingle | Francisco Moniche Paulo Henrique Rosado-de-Castro Irene Escudero Elena Zapata Francisco Javier de la Torre Laviana Rosalia Mendez-Otero Magdalena Carmona Pilar Piñero Alejandro Bustamante Lucía Lebrato Juan Antonio Cabezas Alejandro Gonzalez Grabriel R. de Freitas Joan Montaner Increasing Dose of Autologous Bone Marrow Mononuclear Cells Transplantation Is Related to Stroke Outcome: Results from a Pooled Analysis of Two Clinical Trials Stem Cells International |
| title | Increasing Dose of Autologous Bone Marrow Mononuclear Cells Transplantation Is Related to Stroke Outcome: Results from a Pooled Analysis of Two Clinical Trials |
| title_full | Increasing Dose of Autologous Bone Marrow Mononuclear Cells Transplantation Is Related to Stroke Outcome: Results from a Pooled Analysis of Two Clinical Trials |
| title_fullStr | Increasing Dose of Autologous Bone Marrow Mononuclear Cells Transplantation Is Related to Stroke Outcome: Results from a Pooled Analysis of Two Clinical Trials |
| title_full_unstemmed | Increasing Dose of Autologous Bone Marrow Mononuclear Cells Transplantation Is Related to Stroke Outcome: Results from a Pooled Analysis of Two Clinical Trials |
| title_short | Increasing Dose of Autologous Bone Marrow Mononuclear Cells Transplantation Is Related to Stroke Outcome: Results from a Pooled Analysis of Two Clinical Trials |
| title_sort | increasing dose of autologous bone marrow mononuclear cells transplantation is related to stroke outcome results from a pooled analysis of two clinical trials |
| url | http://dx.doi.org/10.1155/2016/8657173 |
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