{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,9]],"date-time":"2026-09-09T05:23:41Z","timestamp":1788931421859,"version":"build-2803163510"},"reference-count":11,"publisher":"SAGE Publications","issue":"7","license":[{"start":{"date-parts":[[2015,6,4]],"date-time":"2015-06-04T00:00:00Z","timestamp":1433376000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"name":"Consejeria de Salud, Junta de Andalucia","award":["PI-0228-2012"],"award-info":[{"award-number":["PI-0228-2012"]}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["International Journal of Stroke"],"published-print":{"date-parts":[[2015,10]]},"abstract":"<jats:sec><jats:title>Rationale<\/jats:title><jats:p> No neuroprotective or neurorestorative therapies have been approved for ischemic stroke. Bone marrow mononuclear cell intra-arterial transplantation improves recovery in experimental models of ischemic stroke. <\/jats:p><\/jats:sec><jats:sec><jats:title>Aims<\/jats:title><jats:p> This trial aims to test safety and efficacy of intra-arterial injection of autologous bone marrow mononuclear cell in ischemic stroke patients. <\/jats:p><\/jats:sec><jats:sec><jats:title>Design<\/jats:title><jats:p> Multicenter, prospective, phase II, randomized, controlled (non-treated group as control), assessor-blinded clinical trial. Seventy-six stroke patients will be enrolled. Patients fulfilling clinical and radiological criteria (e.g. age between 18 and 80 years, middle cerebral artery ischemic stroke with a National Institutes of Health Stroke Scale score of 6\u201320 within one- to seven-days from stroke onset and no lacunar stroke) will be randomized to intervention or control group (1 : 1). Bone marrow harvest and intra-arterial injection of autologous bone marrow mononuclear cell will be done in the intervention group with two different doses (2 \u00d7 10<jats:sup>6<\/jats:sup>\/kg or 5 \u00d7 10<jats:sup>6<\/jats:sup>\/kg in 1 : 1 proportion). Patients will be stratified at randomization by National Institutes of Health Stroke Scale score. Patients will be followed up for two-years. <\/jats:p><\/jats:sec><jats:sec><jats:title>Study outcomes<\/jats:title><jats:p> The primary outcome is the proportion of patients with modified Rankin Scale scores of 0\u20132 at 180 days. Secondary outcomes include National Institutes of Health Stroke Scale and Barthel scores at six-months, infarct volume, mortality, and seizures. <\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion<\/jats:title><jats:p> This is the first trial to explore efficacy of different doses of intra-arterial bone marrow mononuclear cell in moderate-to-severe acute ischemic stroke patients. The trial is registered as NCT02178657. <\/jats:p><\/jats:sec>","DOI":"10.1111\/ijs.12520","type":"journal-article","created":{"date-parts":[[2015,6,5]],"date-time":"2015-06-05T01:53:07Z","timestamp":1433469187000},"page":"1149-1152","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":42,"title":["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"],"prefix":"10.1177","volume":"10","author":[{"given":"Francisco","family":"Moniche","sequence":"first","affiliation":[{"name":"Department of Neurology, Hospital Universitario Virgen del Roc\u00edo, Seville, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Irene","family":"Escudero","sequence":"additional","affiliation":[{"name":"Department of Neurology, Hospital Universitario Virgen del Roc\u00edo, Seville, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elena","family":"Zapata-Arriaza","sequence":"additional","affiliation":[{"name":"Department of Neurology, Hospital Universitario Virgen del Roc\u00edo, Seville, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mar\u00eda","family":"Usero-Ruiz","sequence":"additional","affiliation":[{"name":"Department of Neurology, Hospital Universitario Virgen del Roc\u00edo, Seville, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mar\u00eda","family":"Prieto-Le\u00f3n","sequence":"additional","affiliation":[{"name":"Department of Neurology, Hospital Universitario Virgen del Roc\u00edo, Seville, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Javier","family":"de la Torre","sequence":"additional","affiliation":[{"name":"Department of Neurology, Hospital Universitario Virgen del Roc\u00edo, Seville, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miguel-Angel","family":"Gamero","sequence":"additional","affiliation":[{"name":"Department of Neurology, Hospital Universitario Virgen Macarena, Seville, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jose Antonio","family":"Tamayo","sequence":"additional","affiliation":[{"name":"Department of Neurology, Hospital Regional de Malaga, Malaga, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juan-Jos\u00e9","family":"Ochoa-Sep\u00falveda","sequence":"additional","affiliation":[{"name":"Department of Neurology, Hospital Reina Sofia, Cordoba, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jos\u00e9","family":"Maestre","sequence":"additional","affiliation":[{"name":"Department of Neurology, Hospital Virgen de las Nieves, Granada, 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