Stem Cell Therapy for Heart Failure

(CardiALLO Trial)

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: BioCardia, Inc.

Disqualifiers: Other cardiovascular, medical history, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

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. ^{1 2 3 4 5}

Why 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. ^{4 6 7 8 9}

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

My heart condition moderately affects my daily activities.

Your heart's pumping ability is between 20% and 40%.

I have heart issues due to a past heart attack.

Exclusion Criteria

My heart and health conditions allow me to safely receive the study treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

4-6 weeks

Multiple visits for dose administration and monitoring

Phase II Treatment

Evaluation of effectiveness for improving clinical outcomes with the identified dose from Phase I

12 months

Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

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?

Group I: Study Treatment Active Control 1 Intervention

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.

Group II: Control Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

BioCardia, Inc.

Lead Sponsor

Trials

6

Recruited

790+

Published Research Related to This Trial

Stem cell transplantation, when added to standard medication, significantly improves heart function in chronic heart failure patients, as indicated by a greater reduction in left ventricular end-diastolic volume (LVEDV) compared to standard treatment alone.

Patients receiving stem cell therapy also experience a lower risk of cardiac events, suggesting that this approach not only enhances heart remodeling but also improves overall safety in managing chronic heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A meta-analysis on the efficacy of stem cells transplantation therapy on the prevention of cardiac remodeling and main adverse cardiovascular event in patients with chronic heart failure]. He, W., Wang, G., Quan, XQ., et al.[2013]

Cardiac stem cell therapy using bone-marrow-derived stem cells shows promise for heart regeneration after heart attacks or in heart failure, and initial clinical data suggest it is safe with no increase in adverse events.

However, the confidence in safety is limited due to the small number of patients treated and lack of long-term follow-up, highlighting the need for more extensive data from ongoing and future trials to address potential safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bone-marrow-derived cells for cardiac stem cell therapy: safe or still under scrutiny? Bartunek, J., Vanderheyden, M., Wijns, W., et al.[2007]

Cell transplantation shows promise for treating ischemic cardiomyopathy, with clinical studies indicating benefits like improved heart function and blood flow.

While the overall safety profile of cell transplantation is high, there are potential risks such as ventricular arrhythmias and other adverse effects that can be influenced by factors like the type of cells used and the method of delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential hazards and technical considerations associated with myocardial cell transplantation protocols for ischemic myocardial syndrome. Ben-Dor, I., Fuchs, S., Kornowski, R.[2007]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6544951/

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.117.311827

Dose 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11342608/

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-y

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 ...

5. ahajournals.org ahajournals.org/doi/10.1161/circresaha.116.309717

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 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05925608

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 ...

7. biocardia.com biocardia.com/investors/press-releases/id/1037?pressReleaseId=178

investors “Ischemic heart failure is a common outcome in people who have had previous vascular disease and patients are at increased risk for accelerated ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11235206/

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).

9. bmj.com bmj.com/content/391/bmj-2024-083382

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 ...