NCT05774509: SECRET-HF

Treatment of Non-ischemic Cardiomyopathies by Intravenous Extracellular Vesicles of Cardiovascular Progenitor Cells

Recruiting now Phase 1 Last updated 25 September 2023

What this trial tests

Phase 1 trial testing Extracellular vesicle-enriched secretome of cardiovascular progenitor cells differentiated from induced pluripotent stem cells in Heart Failure With Reduced Ejection Fraction in 12 participants. Currently enrolling.

Timeline

31 May 2023

Primary endpoint
15 August 2025

15 July 2026

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	31 May 2023
Primary completion	15 August 2025
Estimated completion	15 July 2026
Sites	1 location across France

Drugs / interventions tested

• Extracellular vesicle-enriched secretome of cardiovascular progenitor cells differentiated from induced pluripotent stem cells

Conditions studied

• Heart Failure With Reduced Ejection Fraction — all drugs for Heart Failure With Reduced Ejection Fraction →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

Adults 18 to 80, any sex, with Heart Failure With Reduced Ejection Fraction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this clinical trial is to assess the safety and efficacy of three intravenous injections of the extracellulat vesicle-enriched secretome of cardiovascular progenitor cells in severely symptomatic patients with drug-refractory left ventricular (LV) dysfunction secondary to non-ischemic dilated cardiomyopathy. The main questions it aims to answer are:

* Are these repeated injections safe and well tolerated?
* Do they improve cardiac function and, if yes, to what extent?

Publications & conference data

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

1. A critical systematic review of extracellular vesicle clinical trials.
   Mizenko RR, Feaver M, Bozkurt BT, Lowe N, et al · · 2024 · cited 66× · PMID 39330928 · DOI 10.1002/jev2.12510
2. First-in-man use of a cardiovascular cell-derived secretome in heart failure. Case report.
   Menasché P, Renault NK, Hagège A, Puscas T, et al · · 2024 · cited 24× · PMID 38713924 · DOI 10.1016/j.ebiom.2024.105145
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. Defining tropism and activity of natural and engineered extracellular vesicles.
   Choi W, Park DJ, Eliceiri BP. · · 2024 · cited 18× · PMID 38660297 · DOI 10.3389/fimmu.2024.1363185
5. Injury minimization after myocardial infarction: focus on extracellular vesicles.
   Barile L, Marbán E. · · 2024 · cited 17× · PMID 38366191 · DOI 10.1093/eurheartj/ehae089
6. GMP-Compliant Process for the Manufacturing of an Extracellular Vesicles-Enriched Secretome Product Derived From Cardiovascular Progenitor Cells Suitable for a Phase I Clinical Trial.
   Humbert C, Cordier C, Drut I, Hamrick M, et al · · 2025 · cited 14× · PMID 40831309 · DOI 10.1002/jev2.70145
7. Tissue Engineering and Regenerative Medicine: Perspectives and Challenges.
   Hoang VT, Nguyen QT, Phan TTK, Pham TH, et al · · 2025 · cited 11× · PMID 40290901 · DOI 10.1002/mco2.70192
8. Diagnostic and prognostic roles of endothelial- and platelet-derived extracellular vesicles in cardiovascular diseases.
   Di Febo R, Saeed Z, Serafini F, Brocco D, et al · · 2025 · cited 9× · PMID 40380176 · DOI 10.1186/s12967-025-06522-2