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Stem Cell Therapy

Stem Cell Therapy for Cardiomyopathy (CATO Trial)

Phase 2

Recruiting

Led By Roberto Bolli, MD

Research Sponsored by Roberto Bolli

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be receiving guideline driven medical therapy for HF (beta blockers, diuretics, ACE inhibitors or ARBs, or ARNIs, aldosterone antagonists, hydralazine isosorbide) at stable, maximally tolerated doses for ≥ 1 month prior to consent. "Stable" is defined as stable dose with no changes for 30 days after last dose adjustment. For beta blockade "stable" is defined as no greater than a 50% reduction in dose or no more than a 100% increase in dose

Be ≥ 21 and <85 years of age

Must not have

Liver dysfunction evidenced by enzymes (AST and ALT) ˃ 3 times the ULN

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, month 2,4,6,8, & 12

Summary

This trial studies the safety and effectiveness of stem cells to treat heart failure due to reduced blood flow.

Who is the study for?

Adults aged 21-85 with heart failure symptoms, documented coronary artery disease, and left ventricular dysfunction are eligible for this trial. They must be on stable heart medications for at least a month and women of childbearing age should use birth control. Exclusions include severe liver issues, certain allergies, recent cancer history, cognitive barriers to consent, or any condition that might interfere with the study.

What is being tested?

The trial is testing whether injecting umbilical cord-derived mesenchymal stromal cells into patients with ischemic cardiomyopathy can be safe and effective. Participants will receive either one dose or repeated doses intravenously in a randomized double-blind setup against a placebo.

What are the potential side effects?

While specific side effects aren't listed here as it's an early-phase trial assessing safety, potential risks may include immune reactions, infusion-related responses like fever or chills, and complications related to underlying health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I've been on stable heart failure medication for at least a month.

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I am between 21 and 85 years old.

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I experience moderate to moderately severe heart failure symptoms.

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I have severe heart artery blockage, heart muscle damage, and signs of heart failure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My liver enzymes are more than three times the normal limit.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, month 2,4,6,8, & 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, month 2,4,6,8, & 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, month 2,4,6,8, & 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

change in LVEF (D LVEF) between baseline (M0) and 12 months after the first study product infusion (SPI) (M12)

Secondary study objectives

Biomarkers: Change in NT-proBNP

Biomarkers: hs-CRP

Change in Endothelial Progenitor Cell [EPC]-colony forming unit [EPC-CFU] assay

+15 more

Other study objectives

Serious adverse events

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: single-dose groupExperimental Treatment1 Intervention

One dose of UC-MSCs (100 x 106 cells) will be infused IV at a rate of 2 ml/min for a total of 60 ml over 30 minutes (3.3 million cells/ml/min). This will be followed by three IV infusions of placebo (same volume and rate) 2, 4, and 6 months later.

Group II: repeated-dose groupExperimental Treatment1 Intervention

Four doses of UC-MSCs (100 x 106 cells each) will be given 2 months apart. Each dose will be infused IV at a rate of 2 ml/min for a total of 60 ml over 30 minutes (3.3 million cells/ml/min).

Group III: control groupPlacebo Group1 Intervention

Four doses of vehicle (Plasma-Lyte A supplemented with 1% HSA) will be given 2 months apart. Each dose will be infused IV at a rate of 2 ml/min for a total of 60 ml over 30 minutes.

0 / 5Eligibility criteria met