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Stem Cell Therapy

Stem Cell Therapy for Cardiomyopathy (CATO Trial)

Q: Is the age cap for this investigation set at 35 years or older?

According to the eligibility requirements, this study welcomes participants between 21 and 85 years of age.

Q: What criteria must be met for someone to qualify as a participant in this research?

In order to be accepted into this clinical trial, participants must possess coronary artery disease and fall between the ages of 21 and 85. The total number of patients required for enrollment is 60.

Q: What potential hazards exist for individuals receiving a single dose of this treatment?

Our team assigned a score of 2 to the safety risk associated with administering single-dose group, as this is only within Phase 2 trials. Thus far there has been evidence indicating its security but not its efficacy.

Q: Does this clinical trial allow for new participants to join at this time?

At this time, clinicaltrials.gov confirms that recruitment for the trial has ceased - it was initially posted on 1st January 2024 and last updated on 17th November 2023. Nonetheless, 1322 other studies are actively seeking participants now.

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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

CATO Trial 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.Check my eligibility

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.See study design

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.

CATO Trial 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.

Select...

I experience moderate to moderately severe heart failure symptoms.

Select...

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

CATO Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Biomarkers: Change in NT-proBNP

Biomarkers: NK cells, T cells (Tc, Th1, Th2, Th17, Treg), B cells, monocytes, Exhausted B cells and terminally differentiated effector memory CD45RA (TEMRA) T cells

Biomarkers: Neutrophil-to-lymphocyte and platelet-to-lymphocyte ratios

+18 more

Other outcome measures

Serious adverse events

CATO 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 1 ml/min for a total of 60 ml over 60 minutes (1.6 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 1 ml/min for a total of 60 ml over 60 minutes (1.6 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 1 ml/min for a total of 60 ml over 60 minutes.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MiamiOTHER

902 Previous Clinical Trials

410,016 Total Patients Enrolled

4 Trials studying Coronary Artery Disease

565 Patients Enrolled for Coronary Artery Disease

United States Department of DefenseFED

865 Previous Clinical Trials

327,639 Total Patients Enrolled

2 Trials studying Coronary Artery Disease

2,484 Patients Enrolled for Coronary Artery Disease

Roberto BolliLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age cap for this investigation set at 35 years or older?

"According to the eligibility requirements, this study welcomes participants between 21 and 85 years of age."

Answered by AI

What criteria must be met for someone to qualify as a participant in this research?

"In order to be accepted into this clinical trial, participants must possess coronary artery disease and fall between the ages of 21 and 85. The total number of patients required for enrollment is 60."

Answered by AI

What potential hazards exist for individuals receiving a single dose of this treatment?

"Our team assigned a score of 2 to the safety risk associated with administering single-dose group, as this is only within Phase 2 trials. Thus far there has been evidence indicating its security but not its efficacy."

Answered by AI

Does this clinical trial allow for new participants to join at this time?

"At this time, clinicaltrials.gov confirms that recruitment for the trial has ceased - it was initially posted on 1st January 2024 and last updated on 17th November 2023. Nonetheless, 1322 other studies are actively seeking participants now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Roberto Bolli 2024. "Single or Repeated Intravenous Administration of umbiliCAl Cord Mesenchymal sTrOmal Cells in Ischemic Cardiomyopathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06145035.

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