Actively Recruiting
Treatment of Non-ischemic Cardiomyopathies by Intravenous Extracellular Vesicles of Cardiovascular Progenitor Cells
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2023-09-25
12
Participants Needed
1
Research Sites
163 weeks
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
M
Ministry of Health, France
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Treatment of Non-ischemic Cardiomyopathies by Intravenous Extracellular Vesicles of Cardiovascular Progenitor Cells
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 to 80 years
- Signed written informed consent
- Affiliated with French Social Security
- Diagnosed with dilated cardiomyopathy showing a dilated left ventricle with reduced ejection fraction (≤40%) not caused by pressure/volume overload, coronary artery disease, or systemic disease
- For chemotherapy-induced cardiomyopathy, a cancer-free period of at least two years and low risk of recurrence as determined by an oncologist
- NYHA Class III symptoms despite optimal guideline-directed medical therapy, including cardiac resynchronization if needed
- Plasma B-type natriuretic peptide (BNP) level >150 pg/mL or N-terminal pro-BNP (NT-proBNP) ≥400 pg/mL
- For women of childbearing age, effective contraception during treatment and for 3 months after
You will not qualify if you...
- Cardiac resynchronization therapy device or ICD implanted within the last 3 months
- End-stage heart failure defined as ACCF/AHA stage D or terminal heart failure with life expectancy under 12 months
- Use of inotropic agents in the month before inclusion
- Acute heart failure of any cause
- Heart failure caused by valve disease, untreated hypertension, or coronary artery disease explaining cardiomyopathy
- Cardiomyopathy due to reversible causes like endocrine disease, alcohol/drug abuse, myocarditis, Tako-Tsubo, or arrhythmias
- Cardiomyopathy related to syndromic or systemic diseases such as Duchenne's muscular dystrophy or infiltrative disorders
- For post-chemotherapy cardiomyopathy, history of radiation therapy with constrictive physiology, new tumors, recent trastuzumab treatment
- Previous cardiac surgery
- Recent stroke within 3 months
- Known left ventricular thrombus, aortic dissection, or aneurysm
- Uncontrolled ventricular tachycardia or recent ICD firing
- History of severe allergic reactions requiring treatment
- Contraindications to corticosteroids, antihistamines, or gadoterate meglumine if used
- Significant hematological diseases or coagulopathy
- Reduced functional capacity from other diseases such as severe COPD, claudication, or obesity
- Poorly controlled diabetes or proliferative retinopathy
- Dialysis-dependent kidney failure
- Autoimmune diseases or current immunosuppressive therapy
- History of organ transplant or cell-based treatments
- Positive for HIV, hepatitis B or viremic hepatitis C
- Pregnant, nursing, or not using effective birth control if applicable
- Active infections
- Known allergy to aminoglycosides
- Under legal guardianship
- Participation in another interventional trial
- Life expectancy less than one year
- Contraindication to 18FDG-PET scan
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hôpital européen Georges Pompidou
Paris, France, 75015
Actively Recruiting
Research Team
T
Touria EL AAMRI
CONTACT
S
Sabrina BOUDIF
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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