Cell Therapy for Heart Failure

No longer recruiting at 27 trial locations

Overseen By Peter Altman, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: BioCardia, Inc.

Disqualifiers: Other cardiac, vascular, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called CardiAMP cell therapy for people with heart failure. It compares the effects of this cell therapy to a sham treatment to determine if it can improve heart function. The study targets individuals who have experienced heart failure due to a past heart attack, show noticeable symptoms (such as tiredness and difficulty with physical activity), and meet specific heart function criteria. Participants must have been on stable heart treatment for at least three months. The goal is to determine if CardiAMP can significantly impact heart failure management. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications. However, it mentions that participants should be on stable heart failure therapy for at least three months before joining, so you might need to continue your current treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that CardiAMP cell therapy is generally safe for people with heart failure. Studies suggest that this treatment might lower the risk of early death and reduce hospital visits due to heart failure. Specifically, patients who received CardiAMP therapy experienced a 5% lower rate of heart-related deaths over two years. The therapy aims to help people live longer and improve their quality of life, indicating it is well-tolerated. Although the treatment did not show significant benefits in some areas, its safety remains promising based on current research. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

CardiAMP™ Cell Therapy is unique because it uses autologous cell therapy, which means it harnesses the patient’s own bone marrow cells to potentially repair heart tissue. Unlike standard treatments for heart failure, which typically focus on managing symptoms with medications like beta-blockers or ACE inhibitors, CardiAMP aims to address the underlying damage to the heart muscle itself. Researchers are excited about this approach because it represents a shift from symptom management to actual tissue regeneration, offering hope for more substantial and long-lasting improvements in heart function.

What evidence suggests that CardiAMP cell therapy might be an effective treatment for heart failure?

Research has shown that CardiAMP cell therapy, which participants in this trial may receive, might help people with heart failure. Specifically, studies found that patients who received this treatment had a nearly 5% lower chance of dying from heart-related issues over two years compared to those who did not receive it. Additionally, there was a 37% reduction in serious heart problems, resulting in fewer life-threatening heart events. On average, patients were able to exercise about 80 seconds longer. These findings suggest that CardiAMP cell therapy could be a promising way to improve heart health in people with heart failure. ^{1 2 3 6 7}

Who Is on the Research Team?

Carl Pepine, MD

Principal Investigator

University of Florida

Duncan Stewart, MD

Principal Investigator

Ottawa Heart Institute Research Corporation

Amish Raval, MD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

This trial is for people with chronic heart failure due to a past heart attack, who have a left ventricular ejection fraction between 20% and 40%, and are in NYHA Class II or III. They must be on stable heart failure medication for at least three months and pass a bone-marrow screening.

Inclusion Criteria

My heart's left side is weak due to a past heart attack.

I have been on a stable heart failure treatment for at least 3 months.

Before the procedure, the doctor needs to check the patient's bone marrow to make sure it is healthy.

Exclusion Criteria

My heart and blood vessels are healthy based on my recent exams.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Roll-in Phase

A roll-in phase with a maximum of 10 subjects may occur

Not specified

Treatment

Participants receive CardiAMP cell therapy or sham control treatment

12 months

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• CardiAMP™ Cell Therapy
• Sham

Trial Overview The study tests CardiAMP cell therapy against a sham (fake) procedure. It's blinded, meaning patients and evaluators don't know who gets the real treatment. The trial includes up to 10 initial subjects before full randomization.

How Is the Trial Designed?

Group I: CardiAMP cell therapy Experimental Treatment 1 Intervention

Placement of an introducer guidewire, performance of a left ventriculogram, and treatment with autologous cell therapy.

Group II: Sham Comparator Placebo Group 1 Intervention

Placement of an introducer guidewire and performance of a left ventriculogram with no autologous cell therapy treatment.

Who Is Running the Clinical Trial?

BioCardia, Inc.

Lead Sponsor

Trials

6

Recruited

790+

Published Research Related to This Trial

In the CHART-1 clinical trial involving 249 patients with ischemic heart failure, cardiopoiesis-guided cell therapy showed comparable improvements in health-related quality of life as measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ) when compared to a sham procedure, although the overall difference was not statistically significant (P = .107).

However, patients with advanced left ventricular enlargement experienced a significant benefit from cell therapy, with a mean treatment difference of -6.4 points on the MLHFQ (P = .009), indicating that this subgroup may particularly benefit from cell therapy in terms of both quality of life and reduced rates of death and hospitalization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cell Therapy Improves Quality-of-Life in Heart Failure: Outcomes From a Phase III Clinical Trial. Yamada, S., Bartunek, J., Povsic, TJ., et al.[2023]

Interventional heart failure therapies, including mechanical assist devices and heart transplantation, are crucial for treating end-stage refractory heart failure when drug therapies are insufficient.

Emerging treatments like cellular or stem cell therapy show promise for heart failure, alongside the importance of palliative care and self-care strategies in managing the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The new concept of ''interventional heart failure therapy'': part 2--inotropes, valvular disease, pumps, and transplantation. Thompson, KA., Philip, KJ., Simsir, S., et al.[2010]

The CardiAMP Heart Failure trial demonstrated that personalized marrow-derived cell therapy is feasible and well tolerated in patients with chronic heart failure after a myocardial infarction, with no serious adverse events reported in the initial cohort of 10 patients.

Patients showed significant improvement in their 6-minute walk distance at 6 months (+47.8 m) and trends toward better heart function and quality of life, suggesting potential benefits of this treatment approach for heart failure management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Point of care, bone marrow mononuclear cell therapy in ischemic heart failure patients personalized for cell potency: 12-month feasibility results from CardiAMP heart failure roll-in cohort. Raval, AN., Johnston, PV., Duckers, HJ., et al.[2021]

Cardiac cell therapy has been shown to be safe and offers encouraging efficacy results in restoring heart function for patients with chronic heart failure and acute myocardial infarction.

To maximize the benefits of cardiac cell therapy, it is crucial to address three main challenges: preventing cell migration, increasing cell survival, and enhancing integration into the heart tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Perspectives in cardiac cell therapy]. Menasché, P.[2016]

Cell therapies show promise in treating advanced ischemic heart disease by promoting new blood vessel growth and potentially regenerating heart tissue, which can improve heart function after a heart attack and in heart failure patients.

Research has focused on three key areas: enhancing recovery of the left ventricle after myocardial infarction, improving symptoms in congestive heart failure patients, and treating refractory angina, indicating a broad interest in using cell therapy for various cardiac conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current State of Stem Cell Therapy for Ischemic Heart Disease. Povsic, TJ.[2022]

Citations

1. biocardia.com biocardia.com/investors/press-releases/id/1037?pressReleaseId=217

BioCardia Phase 3 CardiAMP-HF Trial Of Novel Cardiac ... The trial shows us that CardiAMP therapy has the potential to safely and significantly improve survival and quality of life for heart failure patients in ...

2. pcronline.com pcronline.com/News/Press-releases/2024/BioCardia-reports-positive-interim-results-from-phase-III-CardiAMP-cell-therapy-heart-failure-trial-with-compelling-data-in-subgroup-with-elevated-NTproBNP-biomarker-for-heart-failure

BioCardia reports positive interim results from phase III ... Patients treated with CardiAMP cell therapy saw an almost 5% lower rate of heart death equivalents at up to two years compared to control ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10658138/

The CardiAMP Cell Therapy for Heart Failure trial - PMC Notably, available 24-month follow-up data suggest a 37% relative risk reduction in cardiac death equivalents and an 18% relative risk reduction ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06258447

Study Details | NCT06258447 | CardiAMP Heart Failure II ... The purpose of the study is to determine the safety and efficacy of CardiAMP cell therapy system in patients with ischemic heart failure.

5. dicardiology.com dicardiology.com/content/biocardia-releases-primary-endpoint-results-open-label-roll-cohort-cardiamp-cell-therapy

BioCardia Releases Primary Endpoint Results of Open ... Patients experienced increased exercise tolerance of an average of 80 seconds and an average of 82% reduction in angina episodes at the six- ...

6. hcplive.com hcplive.com/view/cardiamp-a-heart-failure-cell-therapy-misses-mark-in-phase-3-trial

CardiAMP, a Heart Failure Cell Therapy, Misses Mark in ... Analysis of primary outcome data suggested use of CardiAMP cell therapy did not provide a statistically significant benefit for the ...

7. citoday.com citoday.com/news/biocardias-cardiamp-cell-therapy-heart-failure-trial-reports-interim-data

BioCardia's CardiAMP Cell Therapy Heart Failure Trial ... Furthermore, patients treated with CardiAMP cell therapy had an approximately 5% lower rate of heart death equivalents at up to 2 years compared ...