CardiAMP Cell Therapy for Chronic Myocardial Ischemia
(CardiAMP-CMI Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: BioCardia, Inc.
Must be taking: Anti-angina drugs
Disqualifiers: Other cardiac, vascular, health conditions
No Placebo Group
Approved in 1 Jurisdiction
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.
12345How 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.
46789Eligibility 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.
+6 more
Exclusion Criteria
My heart and blood vessels are healthy based on my medical history and physical exams.
Trial 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
Participant Groups
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.
2Treatment groups
Active Control
Placebo Group
Group I: CardiAMP cell therapy systemActive Control1 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 controlPlacebo Group1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of FloridaGainesville, FL
University of Wisconsin MadisonMadison, WI
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Who Is Running the Clinical Trial?
BioCardia, Inc.Lead Sponsor
References
[Effect of cell therapy in patients with chronic ischaemic heart disease--a survey of a Cochrane review]. [2016]The present Cochrane review included 23 studies randomized placebo-controlled clinical trials with a total of 1,255 patients. The effect of autologous cell therapy versus placebo was examined on left ventricular ejection fraction (LVEF), adverse effects and mortality in patients with chronic ischaemic heart disease. Patients treated with cell therapy had improved LVEF and functional status compared to patients who received placebo. There were no cell-related and only few procedure-related side effects. A positive effect of cell therapy on long-term survival was also demonstrated.
[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 to repair broken hearts. [2012]Current therapeutic options for myocardial infarction include medical therapy, of proven but limited benefit, and various surgical options, which have either restricted applicability or unproven benefit. New cellular-based therapeutic strategies are being developed in response to the shortcomings of available treatments. These include attempts to reinitiate cardiomyocyte proliferation in the adult, conversion of fibroblasts to contractile myocytes and transplantation of myocytes into injured myocardium. The development and current status of these techniques and their relative advantages, problems remaining to be solved and potential clinical applications are reviewed.
Current State of Stem Cell Therapy for Ischemic Heart Disease. [2022]Improvements in the care of patients with ischemic cardiovascular disease have led to improved survival but also a burgeoning population of patients with advanced ischemic heart disease. Cell therapies offer a novel approach toward cardiac "rejuvenation" via stimulation of new blood vessel growth, enhancing tissue perfusion, and via preservation or even regeneration of myocardial tissue, leading to improvements in cardiac performance after myocardial infarction and in patients with advanced heart failure. Here, we summarize and offer some thoughts on the state of the field of cell therapy for ischemic heart disease, targeting three separate conditions that have been the subject of significant clinical research: enhancing left ventricular recovery after MI, improving outcomes and symptoms in patients with congestive heart failure (CHF), and treatment of patients with refractory angina, despite maximal medical therapy.
[Cell therapies in cardiology: results from the first randomized clinical trials]. [2007]Following acute myocardial infarction, necrotic cardiac tissue is replaced by scar leading to ventricular remodeling and pump failure. Transplantation of autologous bone marrow-derived cells into the heart, early post-infarct, aims to prevent ventricular remodeling. This strategy has been evaluated in four controlled, randomized clinical trials, which provided mixed results. A transient improvement in ventricular function was observed in one trial, and a modest improvement (the duration of which remains to be determined) in an additional trial, whereas two trials showed negative results. A modest benefit of bone marrow cell transplantation was also observed in patients with chronic ischemic heart disease. Despite mixed results reported so far, cell therapy of heart disease still is in its infancy and has considerable room for improvement.
Local implantation of autologous bone marrow cells for therapeutic angiogenesis in patients with ischemic heart disease: clinical trial and preliminary results. [2019]A new therapy for severe ischemic heart disease has been developed; therapeutic angiogenesis induced by the local implantation of autologous bone marrow cells (BMC). After confirming that no detrimental changes were induced by this treatment in a canine heart model, a clinical trial was commenced in 1999. Thus far, 5 patients have been given this new treatment concomitant with coronary artery bypass grafting and all have been followed up for at least 1 year. Autologous BMC were implanted into the ungraftable area and postoperative cardiac scintigraphy showed specific improvement in coronary perfusion in 3 of the 5 patients. Postoperative chest radiography, electrocardiography, echocardiography and blood tests did not reveal any detrimental changes. In conclusion, this new therapy appears to be safe and could provide a treatment option for patients with otherwise untreatable ischemic heart disease.
[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.
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.
Intracoronary cardiosphere-derived cells for heart regeneration after myocardial infarction (CADUCEUS): a prospective, randomised phase 1 trial. [2022]Cardiosphere-derived cells (CDCs) reduce scarring after myocardial infarction, increase viable myocardium, and boost cardiac function in preclinical models. We aimed to assess safety of such an approach in patients with left ventricular dysfunction after myocardial infarction.