CardiAMP Cell Therapy

The investigational CardiAMP™ Cell Therapy is designed to be a comprehensive biotherapeutic heart failure solution, incorporating:

  •  a proprietary molecular diagnostic to characterize the potency of a patient’s own bone marrow cells and determine if they are an optimal candidate for therapy
  •  a point of care processing platform to prepare cells at the patient’s bedside
  •  an optimized therapeutic formulation that builds on the total experience in the cardiac stem cell field to-date
  •  a proprietary interventional delivery system that easily navigates a patient’s vasculature to securely deliver the specific dosage of cells in a routine cardiac catheterization procedure

CardiAMP Cell Therapy Procedure

Day 1: Mini bone marrow aspirate (~ 1 tablespoon) of patient’s bone marrow cells from their hip bone.  Aspirate sent to BioCardia CLIA laboratory partner.  BioCardia’s proprietary molecular diagnostic assay identifies patients with potent cell characteristics using an In Vitro Diagnostic Multi Indexed Assay.

Day 3 or after: If assay positive, patient presents for 1-hour treatment in cardiac catheterization lab:

                                    Small bone marrow aspirate ( ~4 tablespoons) ~15 minutes                                                      
                                    Cells minimally processed and concentrated into proprietary dosage 
                                    Cells delivered using proprietary Helix Transendocardial Delivery System 
                                    Patient discharged same day or after overnight stay

In both the Phase I clinical trial of 20 patients (the TABMMI trial)  and Phase II randomized placebo-controlled trial of 30 patients (the TACHFT-BMC Trial) CardiAMP cells demonstrated an excellent safety profile in heart failure patients treated at two dosages.  There have been no incidences of treatment-emergent major adverse cardiac events.   The Phase II results from TACHFT-BMC support efficacy relative to patient quality of life and functional capacity, which was shown to be both statistically and clinically significant. The FDA has approved us to begin enrollment of patients in our CardiAMP Phase 3 pivotal, pre-commercial trial using a patient's own cells, administered in the cardiac catheterization lab directly into the heart muscle in cases of serious heart failure following a prior heart attack. The trial is expected to begin in approved centers in late 2016 or early 2017.

CardiAMP Cell Therapy Clinical Trials

BCDA-01: CardiAMP Heart Failure Trial

About 5.7 million Americans are living with heart failure today, with about half a million more diagnosed each year. The CardiAMP Heart Failure Trial is studying an investigational stem cell-based therapy for heart failure that develops after a heart attack. The therapy takes a personalized and minimally-invasive approach to the use
of a patient’s own cells in the treatment of ischemic heart failure, and is designed to stimulate the body’s natural healing response.

The CardiAMP heart failure study is enrolling up to 260 patients at 40 medical centers throughout the United States. The study participants will be randomly placed into one of two groups, a treatment and a sham control group. Neither the patient nor the researcher will know who will be receiving the CardiAMP cell therapy and
who will be receiving the sham treatment. Both groups will be closely monitored throughout the study by a team of physicians and continue to be treated with standard of care medical treatments. 

Learn about the CardiAMP Heart Failure Trial from our investigators







CLICK HERE TO FIND OUT IF YOU OR A LOVED ONE QUALIFIES TO PARTICIPATE IN THE CARDIAMP HEART FAILURE TRIAL

To learn more about this study, visit www.clinicaltrials.gov/ct2/show/NCT02438306

BCDA-02: CardiAMP Chronic Myocardial Ischemia Trial

It is estimated that between 600,000 to 1.8 million patients suffer from refractory angina, with approximately 75,000 new cases diagnosed each year. Refractory Angina is a chronic condition,  in the setting of coronary artery disease, that  is characterized by significant debilitating chest pain that greatly reduces quality of life.

The CardiAMP Chronic Myocardial Ischemia Trial will study an investigational stem cell-based therapy that takes a personalized and minimally-invasive approach to the use of a patient’s own cells in the treatment of chronic myocardial ischemia. Similar to BCDA-01: CardiAMP Heart Failure Trial, the therapy is designed to stimulate the body’s natural healing response.

The CardiAMP Chronic Myocardial Ischemia study will enroll up to 343 patients at 40 medical centers throughout the United States. The study participants will be randomly placed into one of two groups, a treatment and a sham control group. Neither the patient nor the researcher will know who will be receiving the CardiAMP cell therapy and
who will be receiving the sham treatment. Both groups will be closely monitored throughout the study by a team of physicians and continue to be treated with standard of care medical treatments. 

To learn more about this study, visit www.clinicaltrials.gov/ct2/show/NCT03455725

Related Publications:

Raval AN, Pepine CJ.  Clinical Safety Profile of Transendocardial Catheter Injection Systems: A Plea for Uniform Reporting. Cardiovasc Revasc Med, 2020 [in press].

Johnston, PV, Duckers, HJ, Raval, AN, Cook, TD, Traverse, JH, Abraham, WT, Altman, PA, Pepine, CJ. The CardiAMP Heart Failure Trial: Efficacy Outcomes from Roll-In Phase. Presented at the Annual Scientific Sessions of the American Heart Association, November 12, 2018.

Johnston PV, Duckers HJ, Raval AN, Cook TD, Pepine CJ. Not All Stem Cells Are Created Equal. Circ Res. 2018 Sep 28;123(8):944-946.

Raval AN, Cook TD, Duckers HJ, Johnston PV, Traverse JH, Abraham WT, Altman PA, Pepine CJ. The CardiAMP Heart Failure trial: A randomized controlled pivotal trial of high-dose autologous bone marrow mononuclear cells using the CardiAMP cell therapy system in patients with post–myocardial infarction heart failure: Trial rationale and study design, American Heart Journal 201 (2018) 141–148.

Mitsutake Y, Pyum WB, Rouy D, et al. Improvement of local cell delivery using Helix Transendocardial Delivery Catheter in a porcine heart. Int Heart J. 2017.

Bergmann MW, Heeger C, Jaquet K, Boosfeld C, Altman P.  Early Transendocardial Autologous Bone Marrow Injection Of Bone Marrow Derived Mononuclear Cells Following Ischemic Myocardial Events (the Alster - Helix Phase I Study), CRT 2016.

Wong Po Foo et al., The transendocardial autologous cells in ischemic heart failure trial bone marrow mononuclear cells (TAC-HFT-BMC) randomized placebo controlled blinded study, Regenerative Medicine 2015, 10(7s), S169.

Heldman AW, et al Transendocardial Mesenchymal Stem Cells and Mononuclear Bone Marrow Cells for Ischemic Cardiomyopathy The TAC-HFT Randomized Trial JAMA.2013.282909.

de la Fuente LM, Stertzer SH, Argentieri J, Penaloza E, Koziner B, Rouy D, Altman PA. Transendocardial autologous bone marrow in myocardial infarction induced heart failure, two-year follow-up in an open-label phase i safety study (the tabmmi study). EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology. 2011;7:805-812.

Afzal MR et al Adult Bone Marrow Cell Therapy for Ischemic Heart Disease, Circulation Research. 2015.

Fisher SA et al.  Meta-Analysis of Cell Therapy Trials for Patients with Heart Failure.  Circulation Research 2015.

Takahashi, M. et al. (2006) Am J Physiol Heart Circ Physiol. 291:H886-H893.

News


Have questions?
CALL US NOW
: (800) 624-1179
Have questions?
EMAIL US NOW
: info@biocardia.com

biocardia takes a new and comprehensive
approach to heart failure

By introducing patient screening and highly-efficient delivery to stem cell therapy, the company seeks to increase the likelihood of treatment success, enabling more patients to return to the things they love.