Single or Repeated Intravenous Administration of umbiliCAl Cord Mesenchymal sTrOmal Cells in Ischemic Cardiomyopathy

Recruiting Phase 2 Interventional Study
Ischemic Heart Disease
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
21 – 85
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
Roberto Bolli · Other
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About This Trial

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).

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Be ≥ 21 and ≤ 85 years of age. 2. Have documented CAD (\> 70% lesion in at least 1 epicardial vessel) with evidence of myocardial injury, LV dysfunction, and clinical evidence of HF. 3. Have a "detectable" area of myocardial injury defined as ≥ 5% LV involvement (infarct volu…
Contacts

Roberto Bolli, MD

502-608-5426

rbolli@louisville.edu

CONTACT

Michelle Unseld, RN

502-540-3423

michelle.unseld@louisville.edu

CONTACT