A First-in-Human Study to Evaluate the Safety and Efficacy of Left Ventricular Assist Device Combined With Exosome Therapy for Patients With Heart Failure(RESTORATION)

A single-center, randomized, double-blind, placebo-controlled, dose-escalation clinical study to evaluate the safety and tolerability of intravenous infusion of different doses of the investigational exosome preparation in heart failure subjects receiving left ventricular assist device therapy. Subjects will receive exosome or placebo once daily for 3 consecutive days, in addition to optimal medical therapy (OMT). The drug category, dosage and administration of OMT will be recorded as concomitant medications and entered into the Case Report Form (CRF). The OMT regimen (including drug type, dosage, route of administration, treatment duration, etc.) will be documented throughout the study. During the study, subjects will undergo efficacy and safety assessments and/or sample collection. After completion of treatment, follow-up visits will be conducted at Day 28, 6 months and 12 months.