Pipeline

CardiAMP® Autologous Cell Therapy

The investigational CardiAMP™ Autologous 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 Autologous 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 aiifter overnight stay

CardiAMP® Autologous Mononuclear Cell Therapy for Ischemic Heart Failure
BCDA-01/ NCT02438306 and NCT06258447 

Ischemic heart failure of reduced ejection fractions (HFrEF) affects more than 1 million patients in the United States, and although there are important new medicines, they have not had a significant impact on the significant 10% mortality per years experienced by these patients. 

In HFrEF we have completed enrollment in three clinical studies, enrolling more than 180 patients: the TABMMI Study, the TACHFT Study, and the CardiAMP Heart Failure Study.    Results have been promising to date with no significant safety concerns and meaningful trends towards benefit across many outcome measures.  For additional details on these studies, please see the available study publications.  

We are currently actively enrolling in the CardiAMP Heart Failure II Trial including up to 250 patients at up to 40 centers in the United States.

To learn more about the CardiAMP HF II trial that is actively enrolling patients, see                                                           www.CardiAMPTrial.com

CardiAMP® Autologous Mononuclear Cell Therapy for Chronic Myocardial Ischemia

BCDA-02/NCT03455725   

Chronic myocardial ischemia which causes painful refractory chest pain impacts up to 1.8 million patients in the United States.   Patients suffer from poor perceived health status and psychological distress, have significant impairment in quality of life, and represent a burden to the healthcare system due to significant use of resources.

The CardiAMP Chromic Myocardial Ischemia (CMI) Trial has completed its roll in cohort of open label patients and early promising results were shared in April 2024.  Final six-month follow-up on these patients are expected in 2025. 

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.