Actively Recruiting
Single or Repeated Intravenous Administration of umbiliCAl Cord Mesenchymal sTrOmal Cells in Ischemic Cardiomyopathy
Led by Roberto Bolli · Updated on 2026-05-13
60
Participants Needed
3
Research Sites
234 weeks
Total Duration
On this page
Sponsors
R
Roberto Bolli
Lead Sponsor
U
University of Miami
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a Phase IIA, randomized, double blind, placebo controlled, multicenter study designed to assess the safety, feasibility, and efficacy of umbilical cord derived mesenchymal stromal cells (UC MSCs, stem cells), administered intravenously (IV) as a single dose or repeated doses, in patients with ischemic cardiomyopathy (ICM).
CONDITIONS
Official Title
Single or Repeated Intravenous Administration of umbiliCAl Cord Mesenchymal sTrOmal Cells in Ischemic Cardiomyopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be between 21 and 85 years of age.
- Have documented coronary artery disease with at least one epicardial vessel showing >70% blockage and evidence of heart muscle injury and heart failure symptoms.
- Have an area of heart muscle injury involving at least 5% of the left ventricle confirmed by MRI.
- Have left ventricular ejection fraction (EF) of 40% or less by MRI.
- Be receiving stable, guideline-recommended heart failure medications for at least one month before consent.
- Have New York Heart Association (NYHA) class I, II, or III heart failure symptoms.
- If female and able to have children, be willing to use birth control and undergo pregnancy testing before treatment.
You will not qualify if you...
- Need for heart surgery, left ventricular assist device placement, imminent heart transplant, or recent coronary artery procedures within 3 months before enrollment.
- Severe valve problems within 12 months before consent.
- Stroke within 90 days before consent.
- Presence of a pacemaker or defibrillator device with specific conditions making MRI unsafe.
- Pacemaker dependence with implantable cardioverter defibrillator.
- Cardiac resynchronization therapy device implanted less than 3 months before consent.
- Other MRI contraindications such as body size.
- Recent serious heart rhythm problems or active myocarditis.
- Poor kidney function with estimated glomerular filtration rate less than 35 ml/min/1.73m2.
- High blood sugar (HbA1c >10%).
- Blood abnormalities such as low hematocrit, white blood cell, or platelet counts.
- Liver dysfunction with elevated liver enzymes.
- HIV or active hepatitis B or C infection.
- History of severe allergic reaction to penicillin or streptomycin.
- Prior gene or cell therapy within the last year.
- Recent cancer within 2 years except certain treated skin and cervical cancers.
- Life expectancy less than 1 year.
- Recent drug or alcohol abuse or related problems.
- Participation in another investigational trial within 30 days.
- Cognitive or language barriers preventing informed consent.
- Pregnancy, breastfeeding, or plans to become pregnant during the study.
- Any other condition judged by the investigator to interfere with study participation.
AI-Screening
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Trial Site Locations
Total: 3 locations
1
University of Miami Miller School of Medicine
Miami, Florida, United States, 33136
Actively Recruiting
2
University of Louisville School of Medicine, Institute of Molecular Cardiology
Louisville, Kentucky, United States, 40202
Actively Recruiting
3
The Texas Heart Institute Houston Texas
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
R
Roberto Bolli, MD
CONTACT
M
Michelle Unseld, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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