Mesenchymal Stem Cell-Based Heart Cell Therapy: The Effect of Route of Cell Delivery in the Clinical Perspective

Kalou, Yazan; Hashemi, Ammar S. A.; Joudeh, Rayan M.; Aramini, Beatrice; Haider, Khawaja Husnain

doi:10.1007/978-981-16-0301-3_6

Cited by 3 publications

(2 citation statements)

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“…, damaged myocardium, in large enough numbers with high viability, maintain their stemness and original phenotype and are retained at the injury site for long enough time to participate in the repair process with minimal off-target accumulation. Some commonly used RoD in the reported clinical studies encompass IM, IC, retrograde intracoronary (IC) sinus, IV, TESI, and scaffold-based delivery methods, each with advantages and limitations[ 16 ]. Our study provides a systematic review and meta-analysis of twelve published phase II RCTs to determine if different RoD affect the safety and efficacy of MSCs during HF treatment.…”

Section: Discussionmentioning

confidence: 99%

“…To date, numerous studies have investigated the efficacy of MSCs using various RoD, with the most commonly employed methods being transendocardial (TESI), transepicardial injection (TEPI) under direct vision, IC infusion, and intravenous (IV) infusion[ 16 ]. Each RoD has its own set of advantages and limitations, encompassing factors such as delivery method convenience, invasiveness level, capability for site-directed cell delivery, the need for adjunct procedures, i.e.…”

Section: Introductionmentioning

confidence: 99%

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Establishing delivery route-dependent safety and efficacy of living biodrug mesenchymal stem cells in heart failure patients

Jihwaprani,

Sula,

Charbat

et al. 2024

World J Cardiol

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BACKGROUND Mesenchymal stem cells (MSCs) as living biopharmaceuticals with unique properties, i.e. , stemness, viability, phenotypes, paracrine activity, etc. , need to be administered such that they reach the target site, maintaining these properties unchanged and are retained at the injury site to participate in the repair process. Route of delivery (RoD) remains one of the critical determinants of safety and efficacy. This study elucidates the safety and effectiveness of different RoDs of MSC treatment in heart failure (HF) based on phase II randomized clinical trials (RCTs). We hypothesize that the RoD modulates the safety and efficacy of MSC-based therapy and determines the outcome of the intervention. AIM To investigate the effect of RoD of MSCs on safety and efficacy in HF patients. METHODS RCTs were retrieved from six databases. Safety endpoints included mortality and serious adverse events (SAEs), while efficacy outcomes encompassed changes in left ventricular ejection fraction (LVEF), 6-minute walk distance (6MWD), and pro-B-type natriuretic peptide (pro-BNP). Subgroup analyses on RoD were performed for all study endpoints. RESULTS Twelve RCTs were included. Overall, MSC therapy demonstrated a significant decrease in mortality [relative risk (RR): 0.55, 95% confidence interval (95%CI): 0.33-0.92, P = 0.02] compared to control, while SAE outcomes showed no significant difference (RR: 0.84, 95%CI: 0.66-1.05, P = 0.11). RoD subgroup analysis revealed a significant difference in SAE among the transendocardial (TESI) injection subgroup (RR = 0.71, 95%CI: 0.54-0.95, P = 0.04). The pooled weighted mean difference (WMD) demonstrated an overall significant improvement of LVEF by 2.44% (WMD: 2.44%, 95%CI: 0.80-4.29, P value ≤ 0.001), with only intracoronary (IC) subgroup showing significant improvement (WMD: 7.26%, 95%CI: 5.61-8.92, P ≤ 0.001). Furthermore, the IC delivery route significantly improved 6MWD by 115 m (WMD = 114.99 m, 95%CI: 91.48-138.50), respectively. In biochemical efficacy outcomes, only the IC subgroup showed a significant reduction in pro-BNP by -860.64 pg/mL (WMD: -860.64 pg/Ml, 95%CI: -944.02 to -777.26, P = 0.001). CONCLUSION Our study concluded that all delivery methods of MSC-based therapy are safe. Despite the overall benefits in efficacy, the TESI and IC routes provided better outcomes than other methods. Larger-scale trials are warranted before implementing MSC-based therapy in routine clinical practice.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%