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- 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.
- Authors
Moniche, Francisco; Escudero, Irene; Zapata-Arriaza, Elena; Usero-Ruiz, María; Prieto-León, María; Torre, Javier; Gamero, Miguel-Angel; Tamayo, Jose Antonio; Ochoa-Sepúlveda, Juan-José; Maestre, José; Carmona, Magdalena; Piñero, Pilar; Calderón-Cabrera, Cristina; Jimenez, Maria-Dolores; Gonzalez, Alejandro; Montaner, Joan
- Abstract
Rationale 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. Aims This trial aims to test safety and efficacy of intra-arterial injection of autologous bone marrow mononuclear cell in ischemic stroke patients. Design 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 6-20 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 × 106/kg or 5 × 106/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. Study outcomes The primary outcome is the proportion of patients with modified Rankin Scale scores of 0-2 at 180 days. Secondary outcomes include National Institutes of Health Stroke Scale and Barthel scores at six-months, infarct volume, mortality, and seizures. Discussion 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.
- Subjects
BONE marrow cells; STROKE; TRANSPLANTATION of organs, tissues, etc.; INTRA-arterial injections; CEREBROVASCULAR disease
- Publication
International Journal of Stroke, 2015, Vol 10, Issue 7, p1149
- ISSN
1747-4930
- Publication type
Article
- DOI
10.1111/ijs.12520