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

39 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical study will utilize allogenic bone marrow-derived culture-expanded MSC that are expanded from mesenchymal stem cells and delivered using the investigational Helix transendocardial delivery catheter as a therapy for ischemic HFrEF with reduced ejection fraction.

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.

What data supports the effectiveness of the treatment CardiALLO for heart failure?

Research shows that stem cell therapy, like CardiALLO, can help improve heart function in patients with heart failure by repairing damaged heart tissue and reducing the risk of future heart problems. Studies have demonstrated benefits such as improved physical activity and reduced long-term mortality in similar treatments using bone marrow stem cells. ^{1 2 3 4 5}

Is stem cell therapy for heart failure safe?

Stem cell therapy for heart failure appears to be generally safe, with studies showing no increased risk of death and some improvement in heart function. However, there are concerns about potential side effects like irregular heartbeats and artery issues, and more research is needed to confirm long-term safety. ^{4 6 7 8 9}

How is the treatment CardiALLO unique for heart failure?

CardiALLO is unique because it uses stem cells, which are special cells that can develop into different types of cells, to help repair the heart by regenerating heart muscle and blood vessels. This approach aims to address the root causes of heart failure, such as scarring and cell loss, which current treatments do not effectively target. ^{5 7 10 11 12}

Research Team

Carl Pepine, MD

Principal Investigator

University of Florida

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effects of Repetitive Transendocardial CD34+ Cell Transplantation in Patients With Nonischemic Dilated Cardiomyopathy. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Cell-based therapy for heart failure. [2007]

3. United States pubmed.ncbi.nlm.nih.gov

Cell therapy for left ventricular remodeling. [2019]

4. China 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]. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

10 years of intracoronary and intramyocardial bone marrow stem cell therapy of the heart: from the methodological origin to clinical practice. [2011]

6. England pubmed.ncbi.nlm.nih.gov

Bone-marrow-derived cells for cardiac stem cell therapy: safe or still under scrutiny? [2007]

7. United States pubmed.ncbi.nlm.nih.gov

Stem cell therapy for heart failure. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Stem Cell Therapy in Advanced Heart Failure Patients: A Systematic Review with a Meta-analysis of Recent Trials Between 2017 and 2019. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Potential hazards and technical considerations associated with myocardial cell transplantation protocols for ischemic myocardial syndrome. [2007]

10. Hungary pubmed.ncbi.nlm.nih.gov

[Stem cell therapy in cardiovascular diseases]. [2009]

11. United States pubmed.ncbi.nlm.nih.gov

Stem celltherapy for ischemic heart failure. [2018]

12. United States pubmed.ncbi.nlm.nih.gov

CD133+ Stem Cell Therapy Effects on Myocardial Regeneration Through Increased Vascular Endothelial Growth Factor Correlate with Cardiac Magnetic Resonance Imaging Results in Coronary Artery Bypass Graft Surgery Patients with Low Ejection Fraction. [2021]