Intra-arterial Bone-marrow Mononuclear Cells Infusion for Acute Ischemic Stroke

Summary

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.

Timeline

Start

2015-04

Primary completion

2021-10-27

Completion

2023-04-12

Publications

• 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.
• 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.
• 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.
• 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.

Drugs

Indications