SENECA Trial Supports Potential Safety, Feasibility of allo-MSC in AIC Patients

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Transendocardial injection of allogeneic mesenchymal stromal cells (allo-MSCs) may be safe and feasible in patients with anthracycline-induced cardiomyopathy (AIC), according to findings from the SENECA trial presented Sept. 30 during the Heart Failure Society of America Virtual Annual Scientific Meeting 2020 and simultaneously published in JACC: CardioOncology. Importantly, the trial also demonstrates that cardiac CMR may be effectively used in heart failure patients despite the high prevalence of devices.

In this first-in-human study of its kind, Roberto Bolli, MD, et al., assessed 37 cancer survivors with chronic AIC – six patients enrolled in an open-label, lead-in phase and 31 patients randomized 1:1 – that received 1 x 108 allo-MSCs or vehicle transendocardially. The primary objectives were safety and feasibility, and the secondary objectives included cardiac function and structure measured by CMR, functional capacity, quality of life, and biomarkers.

Results showed that a total of 97% of patients underwent successful study product injections and all allo-MSC-assigned patients received the target dose of cells. In addition, follow-up visits were well-attended (92%) with successful collection of endpoints in 94% at the one-year visit.

Although 58% of patients had non-CMR compatible devices, the authors discovered that CMR endpoints were successfully collected in 84% of patients imaged at one year, and no new tumors were reported.

Furthermore, there were no significant differences between allo-MSC and vehicle groups with regard to clinical outcomes.

As for efficacy, the authors found that allo-MSC therapy was associated with a significant improvement in quality of life, as measured by the Minnesota Living with Heart Failure Questionnaire score, which is consistent with previous studies of MSC therapy in ischemic heart failure. There was also a borderline significant difference found in exercise tolerance measured by the six-minute walk test, favoring the allo-MSC group.

"This phase 1 study met its primary objectives by demonstrating that allo-MSCs are well-tolerated, that they could be delivered as planned and that the outcome measures could be collected successfully," the authors conclude. "Our exploratory evaluation of efficacy endpoints will be important to design phase 2 and 3 studies. Taken together, these results provide the necessary groundwork for future larger studies focused on efficacy of cell therapy in AIC patients."

In an editorial comment, Ileana L. Piña, MD, MPH, FACC, explains that "this is an important step to the resolution of an undesired effect of chemotherapy that has been deeply concerning to both oncologists and cardiologists, as well as patients and their loved ones. Although it had a small number of participants, this study can be considered a landmark with hope."

Clinical Topics: Cardio-Oncology, Heart Failure and Cardiomyopathies, Acute Heart Failure

Keywords: Quality of Life, Exercise Tolerance, Mesenchymal Stem Cells, Prevalence, Anthracyclines, Heart Failure, Cardiomyopathies, Cell- and Tissue-Based Therapy, Outcome Assessment, Health Care, Neoplasms

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