MedicalResearch.com Interview with:
Javed Butler, M.D., MPH, FACC, FAHA
Chief of the Cardiology Division and Co-Director of the Heart Institute at Stony Brook University
Stony Brook Heart Institute
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: It was previously assumed that stem cells must be delivered directly to the myocardium to improve patient outcomes. However, this delivery mechanism – either in the coronary artery or the myocardium – may not be feasible for millions of patients and for repeat injections. This study represents the first clinical trial to observe the effects of intravenous (IV) administration of ischemia-tolerant mesenchymal stem cells (itMSCs) in patients with chronic heart failure. Results show that an IV injection strategy is safe and well-tolerated.In addition, the data illustrate statistically significant improvement in 6-minute walk test, quality-of-life scores as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) and favorable immune modulatory benefits.
MedicalResearch.com: What should readers take away from your report?
Response: The study’s premise was that the stem cell benefits may be related to their paracrine properties and therefore the benefits should also be retained with IV administration, and, theoretically, enhanced in heart failure patients who do not have any evidence of myocardial scarring. The results support that IV administration is a safe and viable strategy that has the potential to offer significant health benefits.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: Based on these promising findings, study sponsor CardioCell is planning larger studies based on IV delivery of itMSCs for heart failure indication, including assessment of clinical benefit in both non-ischemic and ischemic cardiomyopathy. The completed study used only a single IV injection, so we are designing a subsequent study to include assessment of multiple IV administrations, which may amplify the positive trend observed in the current study.
MedicalResearch.com: Is there anything else you would like to add?
Response: This study indicates that IV itMSC administration may lead to improvement in patient well-being and exerts associated anti-inflammatory effects that may improve cardiac function. Current data suggests that paracrine signaling is mostly responsible for these signs of improvements, which suggests an IV delivery method – which is more practical than direct cardiac administration – is a viable option.
MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.
Study sponsored by CardioCell (www.stemcardiocell.com)
ESC abstrac 2016 t:
Safety and Efficacy of Intravenous Infusion of Ischemia-Tolerant Allogeneic Mesenchymal Stem Cells in Patients With Non-ischemic Cardiomyopathy: Results Of Phase IIa Randomized Controlled Trial
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