Cell Therapy for Heart Failure

Recruiting at 26 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

125 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a prospective, multi-center, randomized, controlled, patient- and evaluator-blinded study comparing treatment with the CardiAMP cell therapy to a sham control treatment. A roll-in phase with a maximum of 10 subjects may occur.

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.

What data supports the effectiveness of the CardiAMP™ Cell Therapy treatment for heart failure?

Research shows that cell therapy can improve quality of life in heart failure patients, especially those with advanced heart conditions, by reducing symptoms and hospitalizations. Additionally, cell therapies have been found to help regenerate heart tissue and improve heart function in patients with heart disease. ^{1 2 3 4 5}

How does CardiAMP™ Cell Therapy differ from other treatments for heart failure?

CardiAMP™ Cell Therapy is unique because it uses a patient's own bone marrow-derived cells to potentially repair heart tissue, which is different from standard treatments that mainly focus on symptom management. This therapy aims to enhance the heart's natural repair mechanisms, offering a novel approach to improving heart function and quality of life in heart failure patients. ^{3 4 6 7 8}

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

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

The new concept of ''interventional heart failure therapy'': part 2--inotropes, valvular disease, pumps, and transplantation. [2010]

2. Netherlands 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. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Cell Therapy Improves Quality-of-Life in Heart Failure: Outcomes From a Phase III Clinical Trial. [2023]

4. France pubmed.ncbi.nlm.nih.gov

[Perspectives in cardiac cell therapy]. [2016]

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

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

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

Stem cell therapy for heart failure. [2021]

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

Gene and cell therapy for heart failure. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Cardiopoietic cell therapy for advanced ischaemic heart failure: results at 39 weeks of the prospective, randomized, double blind, sham-controlled CHART-1 clinical trial. [2022]