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NOT YET RECRUITING
NCT06866600
PHASE1/PHASE2

IPSC-CMs Combined with LVAD or CABG for the Treatment of Heart Failure

Sponsor: HELP Therapeutics Co., Ltd.

View on ClinicalTrials.gov

Summary

This clinical trial investigates the safety, feasibility, and therapeutic potential of a combined approach using HiCM-188 cardiomyocyte injection delivered intramyocardially alongside either LVAD implantation or CABG surgery in patients with advanced ischemic heart failure.

Official title: Study on the Safety and Efficacy of Human IPSC-Derived Cardiomyocytes in the Treatment of End-Stage Heart Failure

Key Details

Gender

All

Age Range

35 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-03

Completion Date

2027-12

Last Updated

2025-03-14

Healthy Volunteers

No

Interventions

BIOLOGICAL

low dose CABG+iPSC-CMs

CABG+0.5×10\^8 iPSC-CMs

BIOLOGICAL

High dose CABG/LVAD+iPSC-CMs

CABG+1.5×10\^8 iPSC-CMs or LVAD+1.5×10\^8 iPSC-CMs

OTHER

CABG/LVAD+Saline

CABG/LVAD+Saline

Locations (1)

HelpThera

Nanjing, Jiangsu, China