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

NCT06866600 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-03-14

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Help Therapeutics

    lead INDUSTRY

Principal Investigators

  • Yongfeng Shao, MD, PhD · Jiangsu Provincial People's Hospital (First Affiliated Hospital of Nanjing Medical University)

  • Liansheng Wang, MD, PhD · Jiangsu Provincial People's Hospital (First Affiliated Hospital of Nanjing Medical University)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-31
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06866600 on ClinicalTrials.gov