Multicentre, randomized, double-blind trial of intracoronary autologous mononuclear bone marrow cell injection in non-ischaemic dilated cardiomyopathy (the dilated cardiomyopathy arm of the MiHeart study)

Martino, Helena Furtado; Brofman, Paulo Roberto Slud; Greco, Oswaldo Tadeu; Bueno, Ronaldo R. L.; Bodanese, Luiz Carlos; Clausell, Nadine Oliveira; Maldonado, Jaime Arnez; Mill, José Geraldo; Braile, Domingo Marcolino; Moraes, João B M C; Silva, Suzana; Bozza, Augusto Z; Santos, Bruna Bento dos; Carvalho, Antonio Campos de

doi:10.1093/eurheartj/ehv477

Cited by 53 publications

(56 citation statements)

References 21 publications

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“…The MiHeart Study had a loss of follow‐up rate of 28.1%; the removal of this trial revealed an improvement of LVEF of 4.78% (95% CI: −1.79% to 7.77%; P = .002). The Bocchi's trail carried the relatively lowest methodological quality.…”

Section: Resultsmentioning

confidence: 94%

“…10 However, most trials using BMMNCs are in the settings of ischaemic DCM, while only a few small-scale randomized controlled trials (RCTs) have studied the effects of stem cells for nonischaemic DCM, with inconsistent data of the improvements after treatment, leaving the therapeutic potential of this intervention difficult to precisely ascertain. To investigate the extent to which BMMNCs transplantation can improve clinical outcomes, a meta-analysis of all known clinical RCTs [11][12][13][14][15][16][17][18][19] meeting the inclusion criteria (see Methods) was performed to critically evaluate and summarize the potential therapeutic benefits of BMMNCs therapy in patients with nonischaemic DCM.…”

Section: Introductionmentioning

confidence: 99%

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Bone marrow‐derived mononuclear cell therapy for nonischaemic dilated cardiomyopathy—A meta‐analysis

Wen

Ding

Zhang

et al. 2018

Eur J Clin Investigation

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Section: Resultsmentioning

confidence: 94%

Section: Introductionmentioning

confidence: 99%

Bone marrow‐derived mononuclear cell therapy for nonischaemic dilated cardiomyopathy—A meta‐analysis

Wen

Ding

Zhang

et al. 2018

Eur J Clin Investigation

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“…The sample sizes for stem cell therapy ranged from 23 to 160, with the longest follow-up ranging from 12 to 60 months. Of the seven identified trials, five trials were multicentre studies [5, 6, 9–11]. Table 3 presents patient and procedural characteristics for the included RCTs.…”

Section: Resultsmentioning

confidence: 99%

“…This heterogeneity was due to multiple factors, including the number of patients enrolled, whether trials were single-centre or multicentre studies, the number of cells injected, routes of injection, and the use of granulocyte colony-stimulating factor (G-CSF) therapy in three trials [5, 6, 9]. The cell types used in the included trials are limited to BM-CD34 cells and BMMNCs.…”

Section: Discussionmentioning

confidence: 99%

“…Recently, a study demonstrated that an intracoronary injection of CD34+ cells was associated with mid-term improvement in ventricular function, exercise tolerance, and long-term survival in a randomised trial of patients with NIDCM [5]. However, two other recent publications [8, 9] reached contradictory results regarding the impact of stem cell therapy on NIDCM patients.…”

Section: Introductionmentioning

confidence: 99%

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A systematic review of randomised controlled trials examining the therapeutic effects of adult bone marrow-derived stem cells for non-ischaemic dilated cardiomyopathy

et al. 2016

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BackgroundCertain early-phase clinical trials have suggested that bone marrow-derived stem cell transplantation might improve left ventricular function in patients with non-ischaemic dilated cardiomyopathy (NIDCM), whereas others trials have revealed no benefit from this approach. We sought to evaluate the therapeutic effects of bone marrow-derived stem cell therapy on NIDCM.MethodsWe searched the PubMed, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) databases (through February 2016) for randomised controlled clinical trials that reported on bone marrow-derived stem cell transplantation for patients with NIDCM with a follow-up period ≥12 months. The co-primary endpoints were changes in mortality rate and left ventricular ejection fraction (LVEF); the secondary endpoints were changes in the 6-minute-walk test (6MWT) and left ventricular chamber size. Seven trials involving bone marrow-derived stem cell therapy that included 482 patients satisfied the inclusion and exclusion criteria.ResultsSubjects who received bone marrow-derived stem cell therapy exhibited a significant reduction in mortality rate (19.7% in the cell group vs. 27.1% in the control group; 95% confidence interval (CI) –0.16 to –0.00, I 2 = 52%, p = 0.04). Bone marrow-derived stem cell therapy tended to produce LVEF improvement within 6 months (1.83% increase; 95% CI –0.27 to 3.94, I 2 = 74%, p = 0.09) and significantly improved LVEF after mid-term (6–12 months) follow-up (3.53% increase; 95% CI 0.76 to 6.29, I 2 = 88%, p = 0.01). However, this therapy produced no significant benefit in the 6MWT (p = 0.18). Finally, the transplantation of increased numbers of stem cells resulted in no observable additional benefit with respect to LVEF.ConclusionsBone marrow-derived stem cell therapy might have improved prognoses and appeared to provide moderate benefits in cardiac systolic function at mid-term follow-up. However, this therapy produced no observed improvement in exercise tolerance.

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Stem cell therapy for dilated cardiomyopathy

Díaz-Navarro

Urrútia

Cleland

et al. 2021

Cochrane Database of Systematic Reviews

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We are uncertain whether SCT in people with DCM reduces the risk of all-cause mortality and procedural complications, improves HRQoL, and performance status (exercise capacity). SCT may improve functional class (NYHA), compared to usual care (no cells).Similarly, when compared to G-CSF, we are also uncertain whether SCT in people with DCM reduces the risk of all-cause mortality although some studies within this comparison observed a favourable e ect that should be interpreted with caution. SCT may not improve HRQoL but may improve to some extent performance status (exercise capacity). Very low-quality evidence reflects uncertainty regarding procedural complications. These suggested beneficial e ects of SCT, although uncertain due to the very low certainty of the evidence, are accompanied by favourable e ects on some physiological measures of cardiac function.Presently, the most e ective mode of administration of SCT and the population that could benefit the most is unclear. Therefore, it seems reasonable that use of SCT in people with DCM is limited to clinical research settings. Results of ongoing studies are likely to modify these conclusions.

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Multicentre, randomized, double-blind trial of intracoronary autologous mononuclear bone marrow cell injection in non-ischaemic dilated cardiomyopathy (the dilated cardiomyopathy arm of the MiHeart study)

Abstract: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00333827.

Cited by 53 publications

References 21 publications

Bone marrow‐derived mononuclear cell therapy for nonischaemic dilated cardiomyopathy—A meta‐analysis

Bone marrow‐derived mononuclear cell therapy for nonischaemic dilated cardiomyopathy—A meta‐analysis

A systematic review of randomised controlled trials examining the therapeutic effects of adult bone marrow-derived stem cells for non-ischaemic dilated cardiomyopathy

Stem cell therapy for dilated cardiomyopathy

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