Zac
Clinical trials

SECRET-HF

Treatment of nonischemic dilated cardiomyopathy by intravenous infusions of the extracellular vesicle-enriched secretome of cardiovascular progenitor cells.

 

Project phases

Discovery
Preclinical
GMP Manufacturing
Phase I Clinical trial
Completed

Clinical trial phase I (NCT05774509)

Pr Philippe Menasché, Cardiac Surgery Department, Georges Pompidou European Hospital, Paris, France.

 

This phase I trial (NCT05774509) is a single-center, open-label study (Hôpital Européen Georges Pompidou, AP-HP) involving 12 adult patients with left ventricular dysfunction due to non-ischemic dilated cardiomyopathy who remain severely symptomatic despite conventional medical treatment.

The main objective of this study is to evaluate the safety of intravenous infusions of Extracellular Vesicle (EV)-enriched secretome derived from Cardiovascular Progenitor Cells (CPC).


This trial is being conducted in close collaboration with Pr Menasché’s research team (Paris Centre de Recherche Cardiovasculaire ; INSERM UMR970 ; Université Paris Cité Paris, France). 

Process development

MEARY Center teams were involved in the development of this process, in particular for the development of Good Manufacturing Practices (GMP)-compliant methods. 

SECRET

Investigational drug manufacturing

The investigational Medical Product (IMP) is a solution containing the EV-enriched secretome released by human induced pluripotent cell (hiPSC)-derived CPC. 

IMP manufacturing steps were carried out by the MEARY Center manufacturing department .

The process is divided into three main parts:

  • Step 1: Expansion and vesiculation of CPC.
  • Step 2: Purification and concentration of the EV-enriched secretome by tangential flow filtration.  
  • Step 3: Sterilising filtration, fill and finish of IMP into glass vials. 


Quality controls during IMP manufacturing were performed by the MEARY Center Quality Control department. 

 

Publication

Desgres M, Lima Correa B, Petrusca L, Autret G, Pezzana C, Marigny C, Guillas C, Bellamy V, Vilar J, Perier MC, Dingli F, Loew D, Humbert C, Larghero J, Churlaud G, Renault N, Croisille P, Hagège A, Silvestre JS, Menasché P. Therapeutic potential of extracellular vesicles derived from cardiac progenitor cells in rodent models of chemotherapy-induced cardiomyopathy. Front Cardiovasc Med. 2023 Jul 7;10:1206279. doi: 10.3389/fcvm.2023.1206279. PMID: 37485274; PMCID: PMC10360184.

Read the article here.