Treating Heart Failure With hPSC-CMs

NCT03763136 | Completed Phase 1 DMC

• 1 other identifier: JWang
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Heart failure has a high morbidity and mortality because the heart is one of the least regenerative organs in the human body. Drug treatments for heart failure manage symptoms but do not restore lost myocytes. Cellular replacement therapy is a potential approach to repair damaged myocardial tissue, restore cardiac function, which has become a new strategy for the treatment of heart failure. The purpose of this study is to assess the safety, feasibility and efficacy of intramyocardial delivery of cardiomyocytes at the time of coronary artery bypass grafting in patients with chronic heart failure.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

• Incidence of sustained ventricular arrhythmias

  defined as the proportion of patients experiencing ventricular arrhythmias lasting more than 30 seconds

  1~6 Month Post-operation

• Incidence of newly formed tumors

  by comparing chest, abdominal and pelvic CT scan and PET-CT scan

  1~12 Month Post-operation

Secondary Outcomes (12)

• Overall Left Ventricular systolic performance as assessed by MRI

  Baseline, 6 and 12 Months Post-operation

• Overall Left Ventricular systolic performance as assessed by Echocardiogram

  Baseline, 6 and 12 Months Post-operation

• Overall Left Ventricular systolic performance as assessed by PET/ECT Scan

  Baseline, 6 and 12 Months Post-operation

• Functional status by 6 minute walk test

  Baseline, 6 and 12 Months Post-operation

• Functional status by New York Heart Association (NYHA) Classification

  Baseline, 6 and 12 Months Post-operation

Study Arms (2)

hPSC-CM Therapy

EXPERIMENTAL

Procedure: Injection of allogenic human pluripotent stem cell-derived cardiomyocytes (hPSC-CMs) during coronary artery bypass grafting surgery. 200 million hPSC-CMs in 2.5-5 mL medium suspension will be injected into the myocardium.

Biological: hPSC-CM Therapy

Control

SHAM COMPARATOR

Procedure: Coronary artery bypass grafting surgery only.

Biological: hPSC-CM Therapy

Interventions

hPSC-CM Therapy BIOLOGICAL

Injection of allogenic human pluripotent stem cell-derived cardiomyocytes (hPSC-CMs) during coronary artery bypass grafting surgery. 200 million hPSC-CMs in 2.5-5 mL medium suspension will be injected into the myocardium.

Control; hPSC-CM Therapy

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 35-75 (including 35 and 75).
• Have signed the Informed Consent Form (ICF).
• Patients have chronic left ventricular dysfunction.
• Patients have NYHA Class III-IV cardiac function even after improved medication for the treatment of advanced chronic heart failure.
• Patients have indications for Coronary Artery Bypass Grafting.
• Weakening or absence of segmental regional wall motion as determined by standard imaging.

You may not qualify if:

• PRA ≥ 20% or DSA-positive.
• Patient received ICD transplantation, CRT or similar treatment.
• Patients with valvular heart disease or received heart valvular disease
• Patients received treatment of percutaneous transluminal coronary intervention (PCI)
• Patients with atrial fibrillation
• Patients previously suffered sustained ventricular tachycardia or sudden cardiac death.
• Baseline glomerular filtration rate \<30ml/min/1.73m2.
• Liver dysfunction, as evidenced by enzymes (AST and ALT) greater than three times the ULN.
• Hematological abnormality: A hematocrit \<25% as determined by HCT, white blood cell\<2500/ul or platelet values \<100000/ul without another explanation.
• Known, serious radiographic contrast allergy, penicillin allergy, streptomycin allergy.
• Coagulopathy (INR\>1.3) not due to a reversible cause.
• Contra-indication to performance of a MRI scan.
• Recipients of organ transplant.
• Clinical history of malignancy within 5 years (patients with prior malignancy must be disease free for 5 years).
• Non-cardiac condition that limits lifespan \<1 year.

Sponsors & Collaborators

• Help Therapeutics: lead
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator

Study Sites (1)

HelpThera

Nanjing, Jiangsu, 210000, China

Location

Related Publications (1)

• Zhang H, Xue Y, Pan T, Zhu X, Chong H, Xu C, Fan F, Cao H, Zhang B, Pan J, Zhou Q, Yang G, Wang J, Wang DJ. Epicardial injection of allogeneic human-induced-pluripotent stem cell-derived cardiomyocytes in patients with advanced heart failure: protocol for a phase I/IIa dose-escalation clinical trial. BMJ Open. 2022 May 6;12(5):e056264. doi: 10.1136/bmjopen-2021-056264.

  PMID: 35523485 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Dongjin Wang, MD

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: To ensure the study results are evaluated without bias, outcomes assessors will not be informed the randomization details.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2018
• First Posted: December 4, 2018
• Study Start: October 8, 2021
• Primary Completion: April 30, 2024
• Study Completion: October 30, 2024
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: One year after study completed
• Access Criteria: Results of the trial will be disseminated to study participants through direct consultation with a trial clinician at completion of the trial, as well as through the publication of results.

Locations

CN (1)