NCT04982081

Treating Congestive HF With hiPSC-CMs Through Endocardial Injection

Status unknown Phase 1 Last updated 23 September 2022

What this trial tests

Phase 1 trial testing hiPSC-CM therapy in Cardiovascular Diseases in 20 participants. Status unknown.

Timeline

21 September 2021

Primary endpoint
30 December 2022

31 July 2023

Quick facts

Lead sponsor	HELP Therapeutics Co., Ltd.
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	20
Start date	21 September 2021
Primary completion	30 December 2022
Estimated completion	31 July 2023
Sites	1 location across China

Drugs / interventions tested

• hiPSC-CM therapy — full drug profile →

Conditions studied

• Cardiovascular Diseases — all drugs for Cardiovascular Diseases →
• Congestive Heart Failure — all drugs for Congestive Heart Failure →
• Dilated Cardiomyopathy — all drugs for Dilated Cardiomyopathy →

Sponsor

HELP Therapeutics Co., Ltd. — full company profile →

Who can join

Adults 18 to 75, any sex, with Cardiovascular Diseases or Congestive Heart Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Heart failure is the primary cause of morbidity and mortality worldwide. Currently drug treatments for heart failure manage the symptoms, but not restore the loss cardiomyocytes due to the very limited regenerative capability in the adult heart. Novel reparative therapies that replace the cardiomyocytes loss are highly demanded to restore the cardiac function. The main purposes of this explanatory study is to investigate the safety and efficacy of the catheter-based endocardial delivery of human iPSC-derived cardiomyocytes in patients with congestive heart failure.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Induced pluripotent stem cells (iPSCs): molecular mechanisms of induction and applications.
   Cerneckis J, Cai H, Shi Y. · · 2024 · cited 248× · PMID 38670977 · DOI 10.1038/s41392-024-01809-0
2. Human Stem Cells for Cardiac Disease Modeling and Preclinical and Clinical Applications-Are We on the Road to Success?
   Correia CD, Ferreira A, Fernandes MT, Silva BM, et al · · 2023 · cited 22× · PMID 37443761 · DOI 10.3390/cells12131727
3. Comparative analysis of regulations and studies on stem cell therapies: focusing on induced pluripotent stem cell (iPSC)-based treatments.
   Song SJ, Nam Y, Rim YA, Ju JH, et al · · 2024 · cited 18× · PMID 39574212 · DOI 10.1186/s13287-024-04065-9
4. Cell Transdifferentiation and Reprogramming in Disease Modeling: Insights into the Neuronal and Cardiac Disease Models and Current Translational Strategies.
   Kalra RS, Dhanjal JK, Das M, Singh B, et al · · 2021 · cited 16× · PMID 34685537 · DOI 10.3390/cells10102558
5. Human induced pluripotent stem cell-derived cardiomyocytes (iPSC-CMs) for modeling cardiac arrhythmias: strengths, challenges and potential solutions.
   Joshi J, Albers C, Smole N, Guo S, et al · · 2024 · cited 15× · PMID 39328831 · DOI 10.3389/fphys.2024.1475152
6. One Billion hiPSC-Cardiomyocytes: Upscaling Engineered Cardiac Tissues to Create High Cell Density Therapies for Clinical Translation in Heart Regeneration.
   Dwyer KD, Kant RJ, Soepriatna AH, Roser SM, et al · · 2023 · cited 13× · PMID 37237658 · DOI 10.3390/bioengineering10050587
7. Advances in 3D Organoid Models for Stem Cell-Based Cardiac Regeneration.
   Martin M, Gähwiler EKN, Generali M, Hoerstrup SP, et al · · 2023 · cited 13× · PMID 36982261 · DOI 10.3390/ijms24065188
8. Preclinical Large Animal Porcine Models for Cardiac Regeneration and Its Clinical Translation: Role of hiPSC-Derived Cardiomyocytes.
   Sridharan D, Pracha N, Rana SJ, Ahmed S, et al · · 2023 · cited 11× · PMID 37048163 · DOI 10.3390/cells12071090