CardiAMP Cell Therapy for Heart Failure
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: BioCardia, Inc.
Must be taking: Heart failure medications
Disqualifiers: Non-candidate for catheterization, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?Concentrated autologous bone marrow mononuclear cells (ABM MNC) contain potentially therapeutic cell factors and past studies support therapeutic benefit to patients with cardiac diseases of acute myocardial infarction, ischemia, and heart failure when utilized as this study is designed. The purpose of the study is to determine the safety and efficacy of CardiAMP cell therapy system in patients with ischemic heart failure. It is a prospective, multi-center, randomized, controlled, patient and evaluator-blinded study comparing treatment with the CardiAMP cell therapy system to a control procedure with diagnostic catheterization.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop your current medications, but it requires that you have been on stable heart failure therapy for at least three months before joining. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the CardiAMP cell therapy treatment for heart failure?
Research shows that cell therapy can improve quality of life for heart failure patients, especially those with advanced heart conditions, by reducing symptoms and hospitalizations. Although initial trials did not show significant improvements, ongoing studies suggest that optimizing cell selection and delivery methods could enhance effectiveness.
12345Is CardiAMP Cell Therapy safe for humans?
Clinical trials suggest that CardiAMP Cell Therapy is generally safe, but there may be some risks like irregular heartbeats and other heart-related issues. The therapy has been tested for heart conditions, and while it shows promise, it's important to consider these potential side effects.
26789How does the CardiAMP cell therapy treatment for heart failure differ from other treatments?
CardiAMP cell therapy is unique because it uses a patient's own bone marrow cells to regenerate heart muscle, aiming to restore heart function by directly injecting these cells into the heart. This approach is different from traditional treatments like medication or surgery, as it focuses on repairing the heart tissue itself rather than just managing symptoms.
24101112Eligibility Criteria
This trial is for people with heart failure due to past heart attacks, who have a weak pumping function (ejection fraction between 20-40%), and certain blood test results. They must be on stable heart medications for at least three months. It's not open to those outside these criteria.Inclusion Criteria
My heart's pumping ability is reduced but not severely impaired.
I have been on a stable heart failure treatment for at least 3 months.
My heart condition moderately affects my daily activities.
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive left ventricular catheterization with treatment consisting of autologous bone marrow mononuclear cells (ABM MNC) processed and delivered using the CardiAMP cell therapy system
12 months
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of functional capacity and quality of life
12-24 months
Extension
Participants may continue to be monitored for long-term outcomes such as all-cause death, heart failure hospitalizations, and quality of life changes
Up to 24 months
Participant Groups
The study tests if injecting one's own processed bone marrow cells into the heart can improve its function in patients with ischemic heart failure. Participants are randomly assigned to receive either this cell therapy or just a diagnostic procedure.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Study (ABM MNC) TreatmentExperimental Treatment1 Intervention
Left ventricular catheterization with treatment consisting of autologous bone marrow mononuclear cells (ABM MNC) processed and delivered using the CardiAMP cell therapy system
Group II: Control TreatmentPlacebo Group1 Intervention
Left ventricular (diagnostic) catheterization but no administration of ABM MNC
CardiAMP cell therapy system is already approved in United States for the following indications:
🇺🇸 Approved in United States as CardiAMP for:
- Ischemic heart failure with reduced ejection fraction
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Morton Plant Hospital - BayCareClearwater, FL
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Who Is Running the Clinical Trial?
BioCardia, Inc.Lead Sponsor
References
The new concept of ''interventional heart failure therapy'': part 2--inotropes, valvular disease, pumps, and transplantation. [2010]Recent advances in heart failure therapy include a variety of mechanical and device-based technologies that target structural aspects of heart failure that cannot be treated with drug therapy alone; these newer therapies can collectively be described as interventional heart failure therapy. This article is the second in a 2-part series reviewing interventional heart failure therapy. Interventions included in this discussion include those indicated for the treatment of end-stage refractory heart failure, including interventional medical therapy, interventional treatment of valvular disease, mechanical assist devices, and heart transplantation. Also included is a review of the currently available catheter-based pumps, which are intended to provide temporary support in patients with acute hemodynamic compromise. The use of cellular or stem cell therapy for the treatment of heart failure is an emerging interventional therapy and data supporting its use for the treatment heart failure will also be presented, as will a discussion of the role of palliative care and self-care in heart failure therapy.
[Perspectives in cardiac cell therapy]. [2016]The objective of cardiac cell therapy is to restore cardiac function in infarct zones. This therapy has been tested for two primary diagnoses: chronic heart failure and acute myocardial infarction. Clinical trials have showed that cardiac cell therapy is safe and that its results in terms of efficacy appear encouraging. Three challenges remain to obtain optimal therapeutic benefits: prevent the migration of these cells, increase their survival, and improve their integration into the recipient myocardium.
Cell therapy in heart failure:where do they stand? [2019]Cell therapy in heart failure: what's up? The routine practice of skin and bone marrow transplantation provides the best illustration that cells can have a therapeutic effect. Attempts have thus be made to exploit this effect for the treatment of heart failure with the initial objective of physically replacing dead cardiomyocytes by new exogenously-supplied cells even though there has been a recent paradigm shift whereby the primary mechanism of action is rather attributed to the cell-derived secretion of factors that would harness endogenous repair pathways. The first wave of clinical trials, which have used cells from various sources, have failed to convincingly demonstrate improved outcomes but these studies have generated data that should now be leveraged for optimizing the efficacy of the technique through the selection of the most functionally efficacious cells, their combination with biomaterials and the development of delivery modalities ensuring an improved initial retention of the cellular graft. Confirmation that the primary mechanism of action is paracrine signaling possible paves the way for an a-cellular cell therapy whereby only secretion products would be administered to the patient while the role of cells would be limited to their in vitro production.
Cardiac cell therapy: a realistic concept for elderly patients? [2021]Established therapeutic concepts for heart failure in elderly patients aim at long-term medical and/or surgical palliation. Heart transplantation is limited to younger individuals, and permanent mechanical assist devices are not yet widely used. In this situation, myocardial cell therapy offers fascinating new perspectives, the ultimate goal being the complete regeneration of heart muscle and blood vessel cells. In small animal models, myocardial cell therapy often leads to a striking improvement of heart function, but the success in man has so far been modest. A possible explanation for the problems with bench-to-bedside translation of cardiac cell therapy is that mainly autologous cell products from aged patients with chronic diseases have been used so far. The aim of this paper is to summarize the current state of development of clinical cardiac cell therapy, to outline how autologous regenerative cells are subject to ageing processes, and to discuss whether the cardiac cell therapy in its present form is a realistic concept for elderly patients.
Cell Therapy Improves Quality-of-Life in Heart Failure: Outcomes From a Phase III Clinical Trial. [2023]Patients with heart failure experience limitations in daily activity and poor quality-of-life. Prospective surveillance of health-related quality-of-life supplemented traditional death and hospitalization outcomes in the multinational, randomized, double-blinded CHART-1 clinical trial that assessed cardiopoiesis-guided cell therapy in ischemic heart failure patients with reduced left ventricular ejection fraction. The Minnesota Living with Heart Failure Questionnaire (MLHFQ), a Food and Drug Administration qualified instrument for evaluating therapeutic effectiveness, was applied through the 1-year follow-up. Cell treated (n = 109) and sham procedure (n = 140) cohorts reported improved MLHFQ scores comparable between the 2 study arms (mean treatment difference with baseline adjustment -3.2 points, P = .107). Superiority of cell treatment over sham in betterment of the MLHFQ score was demonstrated in patients with pre-existing advanced left ventricular enlargement (baseline-adjusted mean treatment difference -6.4 points, P = .009). In this highly responsive subpopulation, benefit on the MLHFQ score paralleled reduction in death and hospitalization post-cell therapy (adjusted Mann-Whitney odds 1.43, 95% CI, 1.01-2.01; P = .039). The potential of cell therapy in addressing the quality-of-life dimension of heart failure requires further evaluation for disease relief.
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]Heart failure following myocardial infarction (MI) is a potentially lethal problem with a staggering incidence. The CardiAMP Heart Failure trial represents the first attempt to personalize marrow-derived cell-based therapy to individuals with cell characteristics associated with beneficial responses in prior trials. Before the initiation of the randomized pivotal trial, an open-label "roll-in cohort" was completed to ensure the feasibility of the protocol's procedures.
Potential hazards and technical considerations associated with myocardial cell transplantation protocols for ischemic myocardial syndrome. [2007]Cell transplantation has recently emerged as a promising therapeutic approach to ischemic cardiomyopathy syndromes. Clinical studies suggest important benefits, including improved myocardial perfusion and function. The safety profile so far seems to be high overall, although the technique may harbor several adverse effects, such as ventricular arrhythmia, acceleration of atherosclerosis or restenosis, and induction of ischemic events. Multiple factors may affect the safety of cell infusion into the diseased heart, including the mode of delivery, the type of cells injected, compound characterization, and the heart status, function, and arrhythmogenic potential. Also, any adjunctive treatment used to enhance cellular homing and/or transdifferentiation increases the likelihood of unexpected local or systemic toxicity or side effects. In the present review, we discuss the potential hazards of this novel treatment and its relationship to technical considerations.
Bone marrow-derived cells for cardiovascular cell therapy: an optimized GMP method based on low-density gradient improves cell purity and function. [2021]Cardiovascular cell therapy represents a promising field, with several approaches currently being tested. The advanced therapy medicinal product (ATMP) for the ongoing METHOD clinical study ("Bone marrow derived cell therapy in the stable phase of chronic ischemic heart disease") consists of fresh mononuclear cells (MNC) isolated from autologous bone marrow (BM) through density gradient centrifugation on standard Ficoll-Paque. Cells are tested for safety (sterility, endotoxin), identity/potency (cell count, CD45/CD34/CD133, viability) and purity (contaminant granulocytes and platelets).
Periprocedural adverse events in cell therapy trials in myocardial infarction and cardiomyopathy: a systematic review. [2021]Cell therapy (CTh) is a promising novel therapy for myocardial infarction (MI) and ischemic cardiomyopathy (iCMP). Recognizing adverse events (AE) is important for safety evaluation, harm prevention and may aid in the design of future trials.
[Perspectives in cardiac cell therapy]. [2016]The objective of cardiac cell therapy is to restore a certain degree of functionality of the infarct zones by injecting stem cells. This therapy was tested primarily in two clinical fields: chronic heart failure and acute myocardial infarction. Clinical trials have showed safety of cardiac cell therapy and encouraging efficacy results. Three challenges for on optimal therapeutic benefit: prevent cells migration, increase their survival and improve their integration within the recipient myocardium. Many perspectives exist in the field of regeneration of cardiac tissue.
[Surgical treatment and transplantation in heart failure]. [2007]Cardiac transplantation still remains the only radical treatment of end-stage heart failure but organ shortage results in the lengthening of the waiting period during which hemodynamic decompensation may occur and then require temporary circulatory support. Improvement in these assist devices now allows to permanently implant some of them which then appear as true alternatives to cardiac transplantation when this technique is contra-indicated. In parallel to these "mechanical" options, "biological" strategies have been designed, which are primarily based on cell therapy. Thus, autologous skeletal myoblast transplantation has yet entered the clinical arena, on the basis of experimental data suggesting the functional efficacy of these cells once implanted into infarcted myocardium. However, the clinical benefits of this approach still need to be validated by randomized trials. Gene therapy appears more complex to implement clinically, because of the multiplicity of candidate genes and the persisting issues associated with vectors and gene transfection systems.
[Stem cell therapy for cardiovascular diseases. Experiences in Düsseldorf]. [2008]The selective transplantation of autologous bone marrow cells (chronic infarction 10 (9) million cells) as well as the intracoronary approach, represents a novel and effective therapeutic procedure. The improvement of autologous stern cell therapy is achieved in addition to the catheter interventional procedures and is a procedure for regeneration of destroyed heart muscle in the early phase after myocardial infarction. In patients with chronic coronary artery disease (mean 108 months after myocardial infarction) intracoronary stern cell therapy leads to significant increase of left ventricular pump function and contractility, reduction of infarct size, increase of myocardial glucose storage and an increase of physical ability (functional capacity) and feeling of well-being. Autologous stern cell therapy in patients with dilated cardiomyopathe seems to be a new option for myocardial restitution. A significant improvement of the subjective aas well as the objective functional capacity was documented. Also a significant reduction of ventricular arrhythmias was revealed in patients with chronic coronary artery disease and non-ischemic cardiomyopathy. Stern cells have the important properties of self-regeneration and organ plasticity. Therefore they are ideal candidates for regeneration of myocardial tissue. The regenerative potential of bone-marrow-derived stern cells may be explained by four mechanisms: 1) direct cell differentiation from monoclear cells to cardiac myocytes, 2) cytokine-induced growing and increase of residual viable myocytes, especially within the border zone of the infracted area, 3) stimulation of resident cardiac stern cells (endogenous stern cells), and 4) induction of cell fusion between transplanted bone marrow cells and resident myocytes. For this method of therapy, no ethical problems exist, and no side effects were observed. The therapeutic benefit for the patient's heart seems to prevail. Peripheral arterial occlusion disease The combined intraarterial and intramuscular transplantation of autologous, mononuclear bone marrow stern cells is a clinical feasible and safe therapeutical option for patients with severe chronic limb ischemia. It leads to a significant increase of the perfusion indices and of the quality of life. Further studies are required to prove the benefit of these new therapeutic approach.