CardiAMP Cell Therapy for Chronic Myocardial Ischemia

(CardiAMP-CMI Trial)

Recruiting at 1 trial location

Overseen By Peter Altman, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: BioCardia, Inc.

Must be taking: Anti-angina drugs

Disqualifiers: Other cardiac, vascular, health conditions

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

343 Participants Needed

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, a type of autologous cell therapy, for individuals with severe chest pain (angina) unresponsive to regular medication. The researchers aim to determine if this therapy can improve heart health by comparing it to a sham treatment, where no real procedure occurs. Suitable participants should experience frequent chest pain episodes (at least seven times a week) and have heart issues that typical procedures cannot resolve. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for those with challenging heart conditions.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should have angina symptoms despite taking the maximum tolerated doses of anti-angina drugs, suggesting you may continue your current medications.

What prior data suggests that the CardiAMP cell therapy system is safe for treating chronic myocardial ischemia?

In a previous study, patients using the CardiAMP Cell Therapy System exercised more and experienced less chest pain. Research has also shown that using a patient's own bone marrow cells might lower the risk of early death and reduce hospital visits for heart failure. This suggests the treatment is generally well-tolerated. The available data has revealed no major safety issues, indicating it might be safe for humans. However, like any treatment, some risks may still exist. Potential participants should discuss these with the study team. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for chronic myocardial ischemia, such as medications to improve blood flow or procedures like angioplasty, the CardiAMP Cell Therapy System offers a novel approach by using a patient's own bone marrow cells to potentially repair heart tissue. Researchers are excited about this treatment because it directly targets the root cause of ischemia by promoting regeneration of the heart muscle, rather than just alleviating symptoms. This cell-based therapy aims to improve heart function and quality of life for patients with limited options, offering hope for more sustainable relief.

What evidence suggests that the CardiAMP Cell Therapy System could be an effective treatment for chronic myocardial ischemia?

Research has shown that the CardiAMP Cell Therapy System, which participants in this trial may receive, can aid in treating chronic myocardial ischemia, a condition where the heart receives insufficient blood. In earlier studies, patients exercised more and experienced fewer chest pain episodes. This suggests the therapy might improve heart function and reduce pain. The therapy uses the patient's own cells to potentially heal heart tissue, contributing to its effectiveness. Early results also indicate fewer hospital visits, demonstrating a positive effect on overall heart health. Participants in this trial may also be assigned to a sham procedure control group, which involves neither the introduction of the trans endocardial delivery catheter nor the administration of autologous cells. ^{1 2 3 4 5}

Who Is on the Research Team?

Amish Raval, MD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

This trial is for adults aged 21-80 with chronic refractory angina, who experience frequent angina episodes despite maximum medication. They must have a heart's left ventricular ejection fraction ≥40%, inducible myocardial ischemia, and coronary disease not suitable for standard treatment. Excludes those with other significant health issues.

Inclusion Criteria

I am between 21 and 80 years old.

Your heart is pumping blood effectively, as shown by an echocardiogram.

You need to pass a bone marrow test before the procedure.

Exclusion Criteria

My heart and blood vessels are healthy based on my medical history and physical exams.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Participants self-reported angina episodes utilizing an electronic diary for 4 weeks at baseline

Roll-in Phase

Up to 10 subjects with refractory chronic myocardial ischemia CCS class III-IV will be treated in an unblinded, uncontrolled roll-in phase

Randomized Treatment

Up to 333 subjects will be randomized to either the CardiAMP cell therapy system or Sham Treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Follow-up visits at 6 and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• CardiAMP Cell Therapy System
• Sham Treatment

Trial Overview The study compares the CardiAMP cell therapy system (a bone marrow cell therapy) to a sham treatment in managing chronic myocardial ischemia and angina. Participants are randomly assigned in a 2:1 ratio to either receive the real treatment or a sham procedure without actual therapy.

How Is the Trial Designed?

Group I: CardiAMP cell therapy system Active Control 1 Intervention

Roll-in phase: Up to 10 subjects with refractory chronic myocardial ischemia CCS class III-IV will be treated in an unblinded, uncontrolled roll-in phase. In the subsequent randomized phase: Up to 333 subjects with refractory chronic myocardial ischemia CCS class III-IV will be randomized. Up to 222 Subjects will be randomized to treatment with the CardiAMP cell therapy system.

Group II: Sham procedure control Placebo Group 1 Intervention

Randomized phase: Up to 333 subjects with refractory chronic myocardial ischemia CCS class III-IV will be randomized. Up to 111 subjects will be treated with a Sham Treatment (no introduction of trans endocardial delivery catheter and no administration of autologous cells)

CardiAMP Cell Therapy System is already approved in United States for the following indications:

Approved in United States as CardiAMP Cell Therapy System for:

• Ischemic heart failure
• Chronic myocardial ischemia with refractory angina

Who Is Running the Clinical Trial?

BioCardia, Inc.

Lead Sponsor

Trials

6

Recruited

790+

Published Research Related to This Trial

Autologous cell therapy significantly improved left ventricular ejection fraction (LVEF) and functional status in patients with chronic ischaemic heart disease compared to placebo, based on a review of 23 randomized controlled trials involving 1,255 patients.

The therapy showed a positive impact on long-term survival with minimal side effects, indicating it is a safe and effective treatment option for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effect of cell therapy in patients with chronic ischaemic heart disease--a survey of a Cochrane review]. Mathiasen, AB., Qayyum, AA., Kastrup, J.[2016]

Transplanting autologous bone marrow-derived cells into the heart after a heart attack has shown mixed results in four randomized clinical trials, with some trials reporting transient or modest improvements in heart function, while others showed no benefit.

Despite the current mixed outcomes, there is potential for improvement in cell therapy for heart disease, indicating that this area of research is still developing and may lead to better treatments in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cell therapies in cardiology: results from the first randomized clinical trials]. Vassalli, G., Gersbach, P., Ferrari, E., et al.[2007]

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]

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]

The new therapy involving the implantation of autologous bone marrow cells (BMC) for severe ischemic heart disease has shown promising safety results, with no detrimental changes observed in clinical assessments after treatment in a canine model and in 5 human patients over at least 1 year.

In 3 out of 5 patients treated alongside coronary artery bypass grafting, there was a specific improvement in coronary perfusion, suggesting that this therapy could be an effective option for patients with otherwise untreatable ischemic heart disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local implantation of autologous bone marrow cells for therapeutic angiogenesis in patients with ischemic heart disease: clinical trial and preliminary results. Hamano, K., Nishida, M., Hirata, K., et al.[2019]

Current treatments for myocardial infarction, such as medical therapy and surgery, have limitations in effectiveness and applicability, prompting the exploration of new cellular-based therapies.

Innovative strategies being developed include promoting heart cell growth, converting fibroblasts into heart muscle cells, and transplanting heart cells into damaged areas, which could offer new hope for improving recovery after heart attacks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cell therapy to repair broken hearts. Li, RK., Yau, TM., Sakai, T., et al.[2012]

Autologous bone marrow cell transplantation shows significant benefits for patients with chronic coronary artery disease, including improved heart function, reduced infarct size, and enhanced physical ability, with no observed side effects.

The therapy works through multiple mechanisms, such as direct differentiation into heart cells and stimulation of existing cardiac stem cells, making it a promising option for heart tissue regeneration after myocardial infarction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Stem cell therapy for cardiovascular diseases. Experiences in Düsseldorf]. Schannwell, CM.[2008]

Myocardial cell therapy shows promise for regenerating heart muscle and improving heart function, especially in small animal models, but its success in human patients, particularly the elderly, has been limited.

The challenges in translating cardiac cell therapy from research to clinical practice may be due to the use of autologous cells from older patients, which are affected by aging processes, raising questions about the therapy's effectiveness for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac cell therapy: a realistic concept for elderly patients? Stamm, C., Nasseri, B., Drews, T., et al.[2021]

The CADUCEUS trial demonstrated that the infusion of autologous cardiosphere-derived cells (CDCs) after myocardial infarction is safe, with no deaths or major adverse cardiac events reported in either the CDC or standard care groups over a 6-month period.

Patients receiving CDCs showed significant improvements in heart tissue health, including reduced scar mass and increased viable heart mass, suggesting potential for cardiac regeneration, although overall heart function measures did not differ significantly from the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intracoronary cardiosphere-derived cells for heart regeneration after myocardial infarction (CADUCEUS): a prospective, randomised phase 1 trial. Makkar, RR., Smith, RR., Cheng, K., et al.[2022]

Citations

1. biocardia.com biocardia.com/pipeline/cardiamp-autologous-cell-therapy/id/8

CardiAMP Autologous Cell Therapy Chronic myocardial ischemia which causes painful refractory chest pain impacts up to 1.8 million patients in the United States. Patients suffer from poor ...

2. biocardia.com biocardia.com/investors/press-releases/id/1037?pressReleaseId=238

CardiAMP cardiac myocardial ischemia top line data BioCardia Announces CardiAMP Chronic Myocardial Ischemia Trial Top Line Data of Roll-in Cohort Show Improved Exercise Tolerance and Reduced ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03455725

CardiAMP Cell Therapy Chronic Myocardial Ischemia Trial The system allows the investigator to identify patients with a high chance to respond to im autologous stem cell therapy (using the CardiAMP Cell Potency Assay) ...

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

The CardiAMP Cell Therapy for Heart Failure trial - PMC These analyses suggest that autologous bone marrow cell-based treatment may reduce early mortality and rehospitalizations as a result of HF.

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 ... ... CardiAMP Cell Therapy in Chronic Myocardial Ischemia Trial. Trial results show improved exercise tolerance and reduced angina episodes at six ...