CI

At a glance

ClinicalIndex Comparison Record
Phase 1Recruiting· 12 target
Drug / intervention
Extracellular vesicle-enriched secretome of cardiovascular progenitor cells differentiated from induced pluripotent stem cellsbiological
Likely dose
Not stated in record
Key inclusion· 7
  • Aged 18 to 80 years
  • Dilated LV with EF ≤40% on echocardiography or CMR
  • Unexplained by pressure/volume overload, CAD, or systemic disease
  • If chemotherapy-induced: ≥2 years cancer-free and ≤30% recurrence risk at 5 years
Key exclusion· 31
  • CRT or ICD implantation in preceding 3 months
  • End-stage HF (ACCF/AHA Stage D) or terminal HF with life expectancy <12 months
  • Inotropic agents in preceding 1 month
  • Acute heart failure

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05774509
NCT05774509Phase 1RecruitingUpdate OverdueUpdated 33mo ago · Completion was 10mo ago
Enrollment Stalled
Long Recruiting
Update Overdue

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

Assistance Publique - Hôpitaux de Paris·interventional·Posted Mar 17, 2023·Updated Sep 25, 2023

In Brief

A Phase 1 clinical trial evaluating Extracellular vesicle-enriched secretome of cardiovascular progenitor cells differentiated from induced pluripotent stem cells for Heart Failure With Reduced Ejection Fraction. Currently recruiting, targeting 12 participants across 1 site.

Signals

Enrollment appears stalled

Detailed 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?

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance

Timeline

Phase 1Recruiting
202420252026
First PostedMar 17, 2023
Enrollment StartMay 31, 2023
Primary CompletionAug 15, 2025
Study CompletionJul 15, 2026
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 3.3 years ago

Interventions

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

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