Evidence map›Paper›PMID 38713924›Full record

ArticleEBioMedicine2024

First-in-man use of a cardiovascular cell-derived secretome in heart failure. Case report.

Philippe Menasché, Nisa K Renault, Albert Hagège, Tania Puscas, Valérie Bellamy, Camille Humbert, Laetitia Le, Hélène Blons, Clémence Granier, Nadine Benhamouda and 4 more

Abstract readCase Reports
PubMed Full text at PMC Publisher
In one paragraph

Article in EBioMedicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

26 citing papers in PubMed.

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  19. Stem Cell Therapy in Ischemic Heart Failure.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Philippe MenaschéAP-HP, Department of Cardiovascular Surgery, Hôpital Européen Georges Pompidou, Paris, France; Université Paris Cité, Inserm, PARCC, Paris, France. Electronic address: philippe.menasche@aphp.fr.
Nisa K RenaultFUJIFILM Cellular Dynamics, Inc (FCDI), Madison, WI, USA.
Albert HagègeUniversité Paris Cité, Inserm, PARCC, Paris, France; AP-HP, Department of Cardiology, Hôpital Européen Georges Pompidou, Paris, France.
Tania PuscasAP-HP, Department of Cardiology, Hôpital Européen Georges Pompidou, Paris, France.
Valérie BellamyUniversité Paris Cité, Inserm, PARCC, Paris, France.
Camille HumbertAP-HP, Hôpital Saint-Louis, MEARY Centre for Cell and Gene Therapy, Paris, France.
Laetitia LeAP-HP, Department of Pharmacy, Hôpital Européen Georges Pompidou, Paris, France; UFR Pharmacie, Université Paris-Saclay, Lip(Sys)(2) Lipides, Systèmes Analytiques et Biologiques, Orsay, France.
Hélène BlonsAP-HP, Department of Biochemistry, Pharmacogenetics and Molecular Oncology, Paris Cancer Institute CARPEM, Hôpital Européen Georges Pompidou, Paris, France.
Clémence GranierUniversité Paris Cité, Inserm, PARCC, Paris, France; Department of Immunology, APHP, Hôpital Européen Georges Pompidou, Paris, France.
Nadine BenhamoudaUniversité Paris Cité, Inserm, PARCC, Paris, France; Department of Immunology, APHP, Hôpital Européen Georges Pompidou, Paris, France.
Anne BacherAP-HP, Department of Cardiology, Hôpital Européen Georges Pompidou, Paris, France.
Guillaume ChurlaudAP-HP, Hôpital Saint-Louis, MEARY Centre for Cell and Gene Therapy, Paris, France.
Brigitte SabatierAP-HP, Pharmacy, Hôpital Européen Georges-Pompidou, Pharmacie, Paris, France; Université Paris-Saclay, Faculté de Pharmacie, Pharmacie Clinique, Orsay, France; HeKA Team, INRIA/INSERM U 1138, CRC/PSC, Paris, France.
Jérôme LargheroAP-HP, Hôpital Saint-Louis, MEARY Centre for Cell and Gene Therapy, Paris, France; Université Paris Cité, AP-HP, Hôpital Saint-Louis, Clinical Investigation Center in Biotherapies CIC-BT, INSERM, Paris, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThere is increased evidence that the effects of stem cells can mostly be duplicated by administration of their secretome which might streamline the translation towards the clinics.

methodsThe 12-patient SECRET-HF phase 1 trial has thus been designed to determine the feasibility and safety of repeated intravenous injections of the extracellular vesicle (EV)-enriched secretome of cardiovascular progenitor cells differentiated from pluripotent stem cells in severely symptomatic patients with drug-refractory left ventricular (LV) dysfunction secondary to non-ischemic dilated cardiomyopathy. Here we report the case of the first treated patient (baseline NYHA class III; LV Ejection Fraction:25%) in whom a dose of 20 × 10

findingsIn addition to demonstrating the feasibility of producing a cardiac cell secretome compliant with Good Manufacturing Practice standards, this case documents the excellent tolerance of its repeated delivery, without any adverse events during or after infusions. Six months after the procedure, the patient is in NYHA Class II with improved echo parameters, a reduced daily need for diuretics (from 240 mg to 160 mg), no firing from the previously implanted automatic internal defibrillator and no alloimmunization against the drug product, thereby supporting its lack of immunogenicity.

interpretationThe rationale underlying the intravenous route is that the infused EV-enriched secretome may act by rewiring endogenous immune cells, both circulating and in peripheral organs, to take on a reparative phenotype. These EV-modified immune cells could then traffic to the heart to effect tissue repair, including mitigation of inflammation which is a hallmark of cardiac failure.

fundingThis trial is funded by the French Ministry of Health (Programme Hospitalier de Recherche CliniqueAOM19330) and the "France 2030" National Strategy Program (ANR-20-F2II-0003). It is sponsored by Assistance Publique-Hôpitaux de Paris.

Indexed as

Heart FailureSecretomeExtracellular VesiclesHumansMaleMiddle AgedTreatment OutcomeCardiovascular progenitor cellsCase reportDilated cardiomyopathyExtracellular vesiclesHeart failureSecretome

Identifiers

PMID38713924
PMCPMC11096705

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.