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

Trial Summary

What is the purpose of this trial?

Prospective, multi-center, 2:1 randomized (Treatment : Sham Control), sham-controlled, double-blinded trial to compare treatment using the CardiAMP cell therapy system to sham treatment Treatment Group: Subjects treated with aBMC using the CardiAMP cell therapy system Sham Control Group: Subjects treated with a Sham Treatment (no introduction of the Helix transendocardial delivery catheter, no administration of aBMC)

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 data supports the effectiveness of the CardiAMP Cell Therapy System treatment for chronic myocardial ischemia?

Research shows that cell therapy can improve heart function and survival in patients with chronic ischemic heart disease. Patients treated with cell therapy had better heart pumping ability and fewer side effects compared to those who received a placebo. ^{1 2 3 4 5}

How is CardiAMP Cell Therapy different from other treatments for chronic myocardial ischemia?

CardiAMP Cell Therapy is unique because it uses the patient's own bone marrow cells to promote the growth of new blood vessels and improve heart function, which is different from traditional treatments that focus on managing symptoms or performing surgery. This therapy aims to regenerate heart tissue and improve blood flow, offering a novel approach for patients with limited treatment options. ^{4 6 7 8 9}

Research Team

Amish Raval, MD

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. Denmark pubmed.ncbi.nlm.nih.gov

[Effect of cell therapy in patients with chronic ischaemic heart disease--a survey of a Cochrane review]. [2016]

2. France pubmed.ncbi.nlm.nih.gov

[Perspectives in cardiac cell therapy]. [2016]

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

Cell therapy to repair broken hearts. [2012]

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

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

5. Switzerland pubmed.ncbi.nlm.nih.gov

[Cell therapies in cardiology: results from the first randomized clinical trials]. [2007]

6. Japan 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. [2019]

7. Germany pubmed.ncbi.nlm.nih.gov

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

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

Cardiac cell therapy: a realistic concept for elderly patients? [2021]

9. England pubmed.ncbi.nlm.nih.gov

Intracoronary cardiosphere-derived cells for heart regeneration after myocardial infarction (CADUCEUS): a prospective, randomised phase 1 trial. [2022]