Suspended

Allogeneic Human iPSC-derived Cardiomyocytes for Severe Congestive Heart Failure

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Study Aim

This phase 1 study aims to evaluate the safety of using allogeneic human iPSC-derived cardiomyocytes as a treatment for severe congestive heart failure, specifically focusing on the incidence of major serious adverse events such as death, fatal myocardial infarction, stroke, and others.

What is being tested

hiPSC-CM therapy

Biological
Who is being recruted

Laminopathies+6

+ Cardiomyopathy, Dilated

+ Cardiovascular Diseases

From 18 to 75 Years
+32 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: September 2021
See protocol details

Summary

Principal SponsorHelp Therapeutics
Study ContactJiaxian Wang, MD, PhD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 21, 2021

Actual date on which the first participant was enrolled.

This study focuses on treating severe congestive heart failure, a condition where the heart struggles to pump blood effectively. The treatment involves using special cells called allogeneic human iPSC-derived cardiomyocytes, specifically HiCM-188, which are produced under strict conditions by Help Therapeutics. These cells are injected directly into the heart muscle through a catheter, a thin tube. The goal is to improve heart function and address the challenges faced by patients with this condition. The study is important as it could potentially offer a new approach to treating severe congestive heart failure. Participants in this study receive either 100 million or 400 million HiCM-188 cells. The safety and effectiveness of this treatment are evaluated at 1, 3, 6, and 12 months after the cell transplantation. The primary outcome measured is the occurrence of serious adverse events, which include death, fatal heart attack, stroke, and other heart-related complications. The study also monitors for any potential risks, such as the development of tumors related to the use of these special cells.

Official TitleTreating Congestive Heart Failure Patients With Human iPSC-derived Cardiomyocytes Through Catheter-based Endocardial Injection
NCT04982081
Principal SponsorHelp Therapeutics
Study ContactJiaxian Wang, MD, PhD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

LaminopathiesCardiomyopathy, DilatedCardiovascular DiseasesHeart DiseasesCardiomegalyHeart FailureCardiomyopathiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, Inborn

Criteria

7 inclusion criteria required to participate
Patients aged 18-75 years (including 18 and 75).
Signed the informed consent.
Patients with congestive heart failure who have received regular treatment for heart failure.
New York Heart Association (NYHA) Class III or IV despite optimal standard of care
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25 exclusion criteria prevent from participating
PRA ≥ 20% or DSA positive.
Patients received treatments such as pacemakers, ICD or CRT device.
Patient with severe valvular disease or presence of a mechanical valve replacement, such as PCI implantation, or patients requiring simultaneous radiofrequency ablation of atrial fibrillation.
Patient with any therapeutic traumatic heart surgery within 30 days.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Group II

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Help Therapeutics

Nanjing, ChinaOpen Help Therapeutics in Google Maps
SuspendedOne Study Center