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

NCT05774509 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-09-25

No results posted yet for this study

Summary

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?

Conditions

  • Heart Failure With Reduced Ejection Fraction

Interventions

BIOLOGICAL

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

Repeated (X3) intravenous infusions of the extracellular vesicle-enriched secretome of cardiovascular progenitor cells (differentiated from human induced pluripotent stem cells)

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Philippe Menasché, MD, PhD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-31
Primary Completion
2025-08-15
Completion
2026-07-15

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05774509 on ClinicalTrials.gov