Evidence map›Paper›PMID 40831309›Full record

ArticleJournal of extracellular vesicles2025

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.

Camille Humbert, Chloé Cordier, Iouri Drut, Michele Hamrick, Jacquelyn Wong, Valérie Bellamy, Justine Flaire, Kiranmayee Bakshy, Florent Dingli, Damarys Loew and 5 more

Registry-linked trialAbstract readEvaluation Study
In one paragraph

Article in Journal of extracellular vesicles, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05774509 (Treatment of Non-ischemic Dilated Cardiomyopathies by Intravenous Infusions of the Extracellular Vesicle-Enriched Secretome of Cardiovascular Progenitor Cells), which is not on this map. Cited by 42 papers.

0numbers the graph read from it
0cells of the map it votes in
42citing 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.

NCT05774509 phase1active not recruitingnot on this map

Treatment of Non-ischemic Dilated Cardiomyopathies by Intravenous Infusions of the Extracellular Vesicle-Enriched Secretome of Cardiovascular Progenitor Cells

TypeinterventionalSponsorAssistance Publique - Hôpitaux de ParisRan2023 to 2027Enrolled11ConditionsHeart Failure With Reduced Ejection FractionArmsExtracellular vesicle-enriched secretome of cardiovascular progenitor cells differentiated from induced pluripotent stem cells
3 · Its place in the literature

Who cites it

42 citing papers in PubMed.

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  15. Moving Beyond the Hype in Extracellular Vesicle Therapy.JACC. Basic to translational science · 2026
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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

15 authors.

Camille HumbertCentre MEARY de Thérapie Cellulaire et Génique de l'Assistance Publique - Hôpitaux de Paris (AP-HP), Direction de la Recherche Clinique et de l'Innovation (DRCI), Paris, France.ORCID https://orcid.org/0009-0003-4760-1364
Chloé CordierCentre MEARY de Thérapie Cellulaire et Génique de l'Assistance Publique - Hôpitaux de Paris (AP-HP), Direction de la Recherche Clinique et de l'Innovation (DRCI), Paris, France.
Iouri DrutCentre MEARY de Thérapie Cellulaire et Génique de l'Assistance Publique - Hôpitaux de Paris (AP-HP), Direction de la Recherche Clinique et de l'Innovation (DRCI), Paris, France.
Michele HamrickFUJIFILM Cellular Dynamics, Inc. (FCDI), Madison, Wisconsin, USA.
Jacquelyn WongFUJIFILM Cellular Dynamics, Inc. (FCDI), Madison, Wisconsin, USA.
Valérie BellamyParis Centre de Recherche Cardiovasculaire (PARCC), Institut National de la Santé et de la Recherche Médicale (INSERM), Université Paris Cité, Paris, France.
Justine FlaireCentre MEARY de Thérapie Cellulaire et Génique de l'Assistance Publique - Hôpitaux de Paris (AP-HP), Direction de la Recherche Clinique et de l'Innovation (DRCI), Paris, France.
Kiranmayee BakshyFUJIFILM Cellular Dynamics, Inc. (FCDI), Madison, Wisconsin, USA.
Florent DingliInstitut Curie, Université Paris Sciences & Lettres (PSL), Centre de Recherche, CurieCoreTech Spectrométrie de Masse Protéomique, Paris, France.
Damarys LoewInstitut Curie, Université Paris Sciences & Lettres (PSL), Centre de Recherche, CurieCoreTech Spectrométrie de Masse Protéomique, Paris, France.ORCID https://orcid.org/0000-0002-9111-8842
Jérôme LargheroCentre MEARY de Thérapie Cellulaire et Génique de l'Assistance Publique - Hôpitaux de Paris (AP-HP), Direction de la Recherche Clinique et de l'Innovation (DRCI), Paris, France.
Jean-Roch FabreguettesCentre MEARY de Thérapie Cellulaire et Génique de l'Assistance Publique - Hôpitaux de Paris (AP-HP), Direction de la Recherche Clinique et de l'Innovation (DRCI), Paris, France.
Philippe MenaschéParis Centre de Recherche Cardiovasculaire (PARCC), Institut National de la Santé et de la Recherche Médicale (INSERM), Université Paris Cité, Paris, France.
Nisa K RenaultFUJIFILM Cellular Dynamics, Inc. (FCDI), Madison, Wisconsin, USA.
Guillaume ChurlaudCentre MEARY de Thérapie Cellulaire et Génique de l'Assistance Publique - Hôpitaux de Paris (AP-HP), Direction de la Recherche Clinique et de l'Innovation (DRCI), Paris, France.

Funding

Assistance Publique - Hôpitaux de ParisFUJIFILM Cellular Dynamics, Inc.Programme Hospitalier de Recherche Clinique - National PHRC-19-0330
6 · The paper itself

Abstract

Extracellular vesicle (EV)-enriched secretomes are emerging as a new and innovative therapeutic option in the field of regenerative medicine. The clinical use of EV-enriched secretome-based products requires manufacturing processes and quality control (QC) testing that comply with current good manufacturing practice (GMP). The goal of this work was to develop a robust and reproducible large-scale GMP-compliant process for the production of an EV-enriched secretome derived from cardiovascular progenitor cells (CPC), including the vesiculation of CPC, purification and concentration of the product; and sterilising filtration. QC strategies for in-process and release testing of an investigational medicinal product (IMP) were developed to guarantee quantity, safety, purity and identity. The IMP showed biological activity and was non-immunogenic in vitro, and showed no signs of toxicity or tumour development in vivo. The IMP was approved for use in a single-centre Phase I clinical trial by the French National Agency for Medicines and Health (ANSM) for the treatment of heart failure. The IMP is stored between -65°C and -85°C and can be easily diluted by the hospital pharmacy for infusion to the patient. This work represents a major advance for the use of CPC derived EV-enriched secretomes as a biological drug for cardiac clinical applications. Trial Registration: ClinicalTrials.gov identifier: NCT05774509.

Indexed as

Extracellular VesiclesSecretomeStem CellsAnimalsClinical Trials, Phase I as TopicHumansProcess Assessment, Health CareQuality ControlRegenerative Medicineextracellular vesicles (EV)GMP manufacturinglarge‐scale process developmentquality controlsecretome

Identifiers

PMID40831309
PMCPMC12365392

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Registered trials

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.