Pipeline

CardiAMP Cell Therapy

•  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.

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.