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

Moniche, Francisco; Cabezas-Rodriguez, Juan Antonio; Valverde, Roberto; Escudero-Martinez, Irene; Lebrato-Hernandez, Lucia; Pardo-Galiana, Blanca; Ainz, Leire; Medina-Rodriguez, Manuel; Torre, Javier de la; Escamilla-Gomez, Virginia; Ortega-Quintanilla, Joaquin; Zapata-Arriaza, Elena; Albóniga-Chindurza, Asier de; Mancha, Fernando; Gamero-García, Miguel Ángel; Perez, Soledad; Espinosa-Rosso, Raul; Forero-Diaz, Lucia; Moya, Miguel; Piñero, Pilar; Calderón-Cabrera, Cristina; Nogueras, Sonia; Jiménez, Rosario; Martı́n, Vanesa; Delgado, Fernando; Ochoa-Sepúlveda, Juan-José; Quijano, Blanca E.; Mata, Rosario; Santos‐González, Mónica; Carmona-Sanchez, Gloria; Herrera, Concha; González, Alejandro; Montaner, Joan

doi:10.1016/s1474-4422(22)00526-9

Cited by 10 publications

(11 citation statements)

References 30 publications

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“…After scanning 53 articles, 19 articles were excluded for not retrieved, and 28 articles were excluded because they were in inappropriate formats, including reviews, non-randomized clinical trials, case reports, and letters. Finally, six RCTs [ 20 , 26 – 31 ] were included in our final meta-analysis. Figure 1 shows a flowchart illustrating the process used for literature searches.…”

Section: Resultsmentioning

confidence: 99%

“…The main characteristics of the six included studies are listed in Table 1 . Four of the research studies were from Asia (two from China, and two from India) [ 26 , 28 – 31 ], one study was from Spain [ 20 ], and one study was from the USA [ 27 ]. The six studies included a total of 343 patients;177 patients were transplanted with BMMNCs; and 166 patients received medical treatment.…”

Section: Resultsmentioning

confidence: 99%

“…Furthermore, BMMNC therapy can play a crucial role in repairing and functionally reconstructing damaged neural circuits [ 43 – 46 ]. The safety of BMMNCs in stroke patients has been confirmed by several clinical trials [ 20 , 47 ]. However, the efficacy of BMMNCs remains controversial.…”

Section: Discussionmentioning

confidence: 95%

“…After examining the doses of all trials, we defined an injection of ≥ 3 × 10 6 BMMNCs/kg as a high dose and < 3 × 10 6 BMMNCs/kg as a low dose. We also categorized the injection methods; three RCTs involved intra-arterial injections [ 20 , 26 , 27 ], one RCT involved intravenous injections [ 28 ], and two RCTs involved subarachnoid injections [ 29 , 30 ].…”

Section: Methodsmentioning

confidence: 99%

“…During the acute phase, BMMNC therapy facilitates neuroprotection mainly by releasing trophic factors, regulating inflammation, and promoting neurorestoration. In the chronic phase, the focus transitions to neurorestoration in patients with a stable chronic deficit [ 20 ].…”

Section: Introductionmentioning

confidence: 99%

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Safety and efficacy of bone marrow mononuclear cell therapy for ischemic stroke recovery: a systematic review and meta-analysis of randomized controlled trials

Tang,

Wang,

Teng

et al. 2024

Neurol Sci

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Background Cell-based therapy represents a potential treatment for ischemic stroke (IS). Here, we performed a systematic review and meta-analysis to summarize the evidence provided by randomized controlled trials (RCTs) for the transplantation of bone marrow mononuclear cells (BMMNCs) in patients with IS in any phase after stroke. Methods We searched several databases for relevant articles up to the 10th of March 2023, including MEDLINE, EMBASE, the Cochrane Library, and ClinicalTrials.gov. Subgroup analyses were implemented to evaluate the dose and route of BMMNC administration. Statistical data were analyzed by Review Manager version 5.3 software. Results Six RCTs were included in this article, including 177 patients who were treated by the transplantation of BMMNCs and 166 patients who received medical treatment. The three-month National Institutes of Health Stroke Scale (NIHSS) score indicated a favorable outcome for the BMMNC transplantation group (standardized mean difference (SMD), − 0.34; 95% confidence interval (CI), − 0.57 to − 0.11; P = 0.004). There were no significant differences between the two groups at six months post-transplantation with regards to NIHSS score (SMD 0.00; 95% CI − 0.26 to 0.27; P = 0.97), modified Rankin Scale (risk ratio (RR) 1.10; 95% CI 0.75 to 1.63; P = 0.62), Barthel Index change (SMD 0.68; 95% CI − 0.59 to 1.95; P = 0.29), and infarct volume change (SMD − 0.08; 95% CI − 0.42 to 0.26; P = 0.64). In addition, there was no significant difference between the two groups in terms of safety outcome (RR 1.24; 95% CI 0.80 to 1.91; P = 0.33). Conclusion Our meta-analysis demonstrated that the transplantation of BMMNCs was safe; however, the efficacy of this procedure requires further validation in larger RTCs.

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Section: Resultsmentioning

confidence: 99%