Stem Cell Therapy for Heart Failure
(CardiALLO Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new stem cell therapy called CardiALLO for individuals with heart failure, specifically those with reduced heart pumping ability due to a past heart attack. The study aims to determine if this therapy, delivered directly into the heart via a special catheter, can improve heart function. It consists of two parts: the first assesses the safe dosage of the treatment, and the second compares the treatment with a placebo procedure to evaluate its effectiveness. Suitable candidates have stable heart failure, a history of heart attack, and some inflammation as indicated by a specific blood test. As a Phase 1, Phase 2 trial, this research focuses on understanding the treatment's effects in people and measuring its effectiveness in an initial, smaller group.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it mentions that participants should be on stable, guideline-directed medical and device therapy. This suggests you may need to continue your current treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that treatments using mesenchymal stem cells (MSCs) have been studied for their safety in people with heart failure. In one study, 30 patients with ischemic cardiomyopathy received MSCs in doses of either 20 million or 100 million cells. The study found that these treatments were well-tolerated, meaning they did not cause serious side effects.
Another study examined different methods of delivering these stem cells to the heart. It found that these methods were safe and effective for treating heart failure.
While these studies suggest that MSC treatments are generally safe, it's important to remember that this trial is in its early stages. Early-phase trials focus on safety, so participation helps researchers learn how well the treatment is tolerated.12345Why do researchers think this study treatment might be promising?
Researchers are excited about CardiALLO for heart failure because it uses allogeneic human mesenchymal stem cells (hMSC), which is a novel approach compared to standard treatments like medications, lifestyle changes, or surgeries. Unlike conventional therapies that primarily manage symptoms, CardiALLO aims to potentially regenerate damaged heart tissue. The treatment is delivered directly to the heart muscle via a specialized catheter, which could enhance the precision and effectiveness of the stem cells. This innovative method might offer a new avenue for healing the heart, rather than just alleviating symptoms.
What evidence suggests that CardiALLO might be an effective treatment for heart failure?
Research has shown that mesenchymal stem cell (MSC) therapy, such as CardiALLO, may help treat heart failure with reduced ejection fraction. This trial will administer different doses of CardiALLO to assess its effectiveness. One study found that patients receiving donor MSCs (stem cells from another person) experienced improved heart function and fewer heart failure symptoms. Another study discovered that varying doses of MSCs enhanced heart function in individuals with ischemic cardiomyopathy, a heart disease caused by narrowed arteries. These findings suggest that CardiALLO could potentially improve heart health and quality of life for those with heart failure.46789
Who Is on the Research Team?
Carl Pepine, MD
Principal Investigator
University of Florida
Are You a Good Fit for This Trial?
This trial is for people with chronic heart failure due to past heart attacks, who are on stable medications and have a left ventricular ejection fraction between 20% and 40%. They should be experiencing mild to moderate symptoms (NYHA Class II or III). Those with other serious medical conditions that could make the treatment unsafe cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase I Treatment
Dose escalation study with three patients at 20 million MSCs, three patients at 100 million MSC, and three patients at 200 million MSC to identify dose for Phase II
Phase II Treatment
Evaluation of effectiveness for improving clinical outcomes with the identified dose from Phase I
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CardiALLO
Trial Overview
The study is testing CardiALLO™, which are special stem cells derived from bone marrow, as a potential treatment for chronic ischemic left ventricular dysfunction. These cells will be delivered directly into the heart muscle using a special catheter.
How Is the Trial Designed?
2
Treatment groups
Active Control
Placebo Group
Phase I of the study will utilize a dose escalation study design with three patients at 20 million MSCs, three patients at 100 million MSC, and three patients at 200 million MSC to identify dose for Phase II. The study treatment (active comparator) is comprised of left ventricular catheterization and treatment with allogeneic hMSC using the Helix transendocardial delivery catheter.
In Phase II of the study, the control group will undergo left ventricular catheterization with introduction of an iliofemoral sheath but no introduction of the Helix transendocardial delivery catheter but no administration of allogeneic hMSC with the Helix transendocardial delivery catheter.
Find a Clinic Near You
Who Is Running the Clinical Trial?
BioCardia, Inc.
Lead Sponsor
Published Research Related to This Trial
Citations
Efficacy of mesenchymal stem cell therapy in systolic heart ...
A phase II dose-escalation study of allogeneic mesenchymal precursor cells in patients with ischemic or nonischemic heart failure. Circ Res. 2015;117(6):576 ...
2.
ahajournals.org
ahajournals.org/doi/10.1161/circresaha.117.311827?doi=10.1161/CIRCRESAHA.117.311827Dose Comparison Study of Allogeneic Mesenchymal Stem ...
Thirty patients with ischemic cardiomyopathy received in a blinded manner either 20 million (n=15) or 100 million (n=15) allogeneic human mesenchymal stem cells ...
Efficacy of mesenchymal stem cell transplantation on major ...
The following search terms were used alone or in combination: heart failure, congestive heart failure, dilated cardiomyopathy, ischemic cardiomyopathy, ...
4.
translational-medicine.biomedcentral.com
translational-medicine.biomedcentral.com/articles/10.1186/s12967-024-05352-yEfficacy of mesenchymal stem cell transplantation on major ...
The following search terms were used alone or in combination: heart failure, congestive heart failure, dilated cardiomyopathy, ischemic ...
Intravenous Allogeneic Mesenchymal Stem Cells for ...
In this pilot study of patients with nonischemic cardiomyopathy, itMSC therapy was safe, caused immunomodulatory effects, and was associated with improvements ...
NCT05925608 | Clinical Trial of Human Allogenic Culture ...
The purpose of this study is to determine the safety, optimal dose and efficacy of CardiALLO cell therapy system in patients with ischemic heart failure with ...
investors
“Ischemic heart failure is a common outcome in people who have had previous vascular disease and patients are at increased risk for accelerated ...
Establishing delivery route-dependent safety and efficacy of ...
This study elucidates the safety and effectiveness of different RoDs of MSC treatment in heart failure (HF) based on phase II randomized clinical trials (RCTs).
phase 3 randomised clinical trial (PREVENT-TAHA8)
Main outcome measures The primary endpoint was incidence of heart failure. Secondary endpoints included readmission to hospital for heart ...
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