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This trial aims to test that intra-arterial injection of autologous bone marrow mononuclear cells in acute ischemic stroke patients is safe and improves neurological outcomes.
This is a study in which the patients will be included diagnosed of ischemic stroke sharply in the territory of the cerebral average artery that there fulfill criteria of incorporation and none of those of exclusion and that they have signed the informed assent. 76 patients will randomize in proportion 2:1:1 in a group control that will receive only medical conventional treatment and in two groups of intervention that will receive an unique intra-arterial infusion of mononuclear autologous bone marrow stem cells (one group of dose of 2 millions of BMSC for kilogram of weight and another group of dose of 5 millions of BMSC for kilogram of weight). The three groups of patients will be followed for 24 months. The randomization will be stratified depending on the NHSS score. This clinical trial has a voluntary substudy to obtain information on plasma biomarkers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bone marrow transplantation low dose | Experimental | Intra-arterial autologous bone marrow mononuclear cells injection (dose 2x10^6 per kilogram) |
|
| Bone marrow transplantation high dose | Experimental | Intra-arterial autologous bone marrow mononuclear cells injection (dose 5x10^6 per kilogram) |
|
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous bone marrow mononuclear cell intra-arterial injection | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disability | Proportion of patients with modified Rankin Scale scores of 0-2 at 6 months | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Functional outcomes | Functional outcome measure by National Institute of Health Stroke Scale and Barthel at 6 months | 6 months |
| Infarct volume | Infarct volume change between baseline (DWI) and 6 months (FLAIR) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francisco Moniche, MD, PhD | Hospitales Universitarios Virgen del Rocío | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Puerta del Mar | Cadiz | 11009 | Spain | |||
| Hospital Universitario Reina Sofía |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40304033 | Derived | Cabezas-Rodriguez JA, Biarnes C, Marti-Navas M, Pineda V, Comas-Cufi M, Pardo-Galiana B, Zapata-Arriaza E, Pinero P, Aguera-Morales E, Valverde R, Ortega-Quintanilla J, Ainz-Gomez L, Baena-Palomino P, Gutierrez I, Medina-Rodriguez M, Ocete-Perez R, Gamero MA, de Alboniga-Chindurza A, Hermosin A, Aguilar-Perez M, Villagran D, Escamilla-Gomez V, Calderon-Cabrera C, Nogueras S, Jimenez R, Martin V, Herrera C, Delgado F, Gonzalez A, Montaner J, Puig J, Moniche F. Diffusion Tensor Imaging Study After Intraarterial Cell Therapy in Acute Ischemic Stroke: A Substudy of the IBIS Randomized Clinical Trial. Stroke. 2025 Aug;56(8):2198-2209. doi: 10.1161/STROKEAHA.124.050261. Epub 2025 Apr 30. | |
| 36681446 |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 6 months |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | 24 months |
| Number of Participants with new-onset seizures as a Measure of Safety and Tolerability | 6 months |
| Functional outcomes | Categorical shift in mRS ordinal (0-6) scale | 6 months |
| Córdoba |
| 14004 |
| Spain |
| Hospitales Universitarios Virgen del Rocio | Seville | 41013 | Spain |
| Hospitales Universitarios Virgen Macarena | Seville | 41071 | Spain |
| Derived |
| Moniche F, Cabezas-Rodriguez JA, Valverde R, Escudero-Martinez I, Lebrato-Hernandez L, Pardo-Galiana B, Ainz L, Medina-Rodriguez M, de la Torre J, Escamilla-Gomez V, Ortega-Quintanilla J, Zapata-Arriaza E, de Alboniga-Chindurza A, Mancha F, Gamero MA, Perez S, Espinosa-Rosso R, Forero-Diaz L, Moya M, Pinero P, Calderon-Cabrera C, Nogueras S, Jimenez R, Martin V, Delgado F, Ochoa-Sepulveda JJ, Quijano B, Mata R, Santos-Gonzalez M, Carmona-Sanchez G, Herrera C, Gonzalez A, Montaner J. Safety and efficacy of intra-arterial bone marrow mononuclear cell transplantation in patients with acute ischaemic stroke in Spain (IBIS trial): a phase 2, randomised, open-label, standard-of-care controlled, multicentre trial. Lancet Neurol. 2023 Feb;22(2):137-146. doi: 10.1016/S1474-4422(22)00526-9. |
| 31852749 | Derived | Mancha F, Escudero-Martinez I, Zapata-Arriaza E, Vega-Salvatierra A, Cabezas JA, Lebrato L, Pardo B, De-La-Torre J, Zapata M, Escamilla V, Calderon-Cabrera C, Martin-Sanchez J, Valverde R, Aguera-Morales E, Herrera I, Delgado F, Gamero MA, Perez-Sanchez S, Moya M, Espinosa R, Ortega-Quintanilla J, Gutierrez-Jarrin I, Gonzalez-Garcia A, Montaner J, Moniche F. Circulating microRNA after autologous bone marrow mononuclear cell (BM-MNC) injection in patients with ischemic stroke. J Investig Med. 2020 Mar;68(3):807-810. doi: 10.1136/jim-2019-001161. Epub 2019 Dec 17. |
| 26044701 | Derived | Moniche F, Escudero I, Zapata-Arriaza E, Usero-Ruiz M, Prieto-Leon M, de la Torre J, Gamero MA, Tamayo JA, Ochoa-Sepulveda JJ, Maestre J, Carmona M, Pinero P, Calderon-Cabrera C, Jimenez MD, Gonzalez A, Montaner J. Intra-arterial bone marrow mononuclear cells (BM-MNCs) transplantation in acute ischemic stroke (IBIS trial): protocol of a phase II, randomized, dose-finding, controlled multicenter trial. Int J Stroke. 2015 Oct;10(7):1149-52. doi: 10.1111/ijs.12520. Epub 2015 Jun 4. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |