Stem Cell Treatment for Ischemic Heart Disease

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.
Ready to participate?

Review the details below, then apply to join this clinical trial.

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
Who this trial is looking for

This trial is looking for adults aged 21 to 85 with ischemic heart disease. Participants will receive stem cells from umbilical cords to see if this treatment is safe and effective for improving heart function.

Are You a Good Fit for This Trial?
Must be taking Beta blockersDiureticsACE inhibitorsARBsARNIsAldosterone antagonists
Rules you out Recent heart surgeryPacemaker dependence with an ICDSevere liver dysfunctionHistory of drug abuse

You may be able to join if

  • I am between 21 and 85 years old.
  • I have heart disease with specific heart problems.
  • I have had a heart scan showing my heart function is weak.
  • I have been treated for heart failure with stable medication for at least a month.
  • I have heart failure symptoms classified as NYHA class I, II or III.
  • If I am a woman who can become pregnant, I will use birth control and take a pregnancy test.

You may not be able to join if

  • I need standard surgery for heart disease currently.
  • I have had a significant stroke in the last 90 days.
  • I have severe heart valve problems.
  • I have received any type of heart device recently.
  • I have a serious heart rhythm problem recently.
  • I have active myocarditis.
  • I have blood tests showing serious health issues.
  • I have been diagnosed with HIV or active hepatitis.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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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