CardiAMP Cell Therapy SystemThe investigational CardiAMP™ 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
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.
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, April 2018.
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.
Heldman AW, Difede DL, Fishman JE, Zambrano JP, Trachtenberg BH, Karantalis V, Mushtaq M, Williams AR, Suncion VY, McNiece IK, Ghersin E, Soto V, Lopera G, Miki R, Willens H, Hendel R, Mitrani R, Pattany P, Feigenbaum G, Oskouei B, Byrnes J, Lowery MH, Sierra J, Pujol MV, Delgado C, Gonzalez PJ, Rodriguez JE, Bagno LL, Rouy D, Altman P, Foo CW, da Silva J, Anderson E, Schwarz R, Mendizabal A, Hare JM. Transendocardial mesenchymal stem cells and mononuclear bone marrow cells for ischemic cardiomyopathy: The TAC-HFT randomized trial. JAMA. 2013
Wong Po Foo C, Ikeno F, Altman P, Rouy D. Quantifying therapeutic cell retention in the heart to compare three routes of local delivery: Transendocardial intramyocardial injection, transepicardial intramyocardial injection, and intracoronary artery infusion. 8th International Conference on Cell Therapy for Cardiovascular Disease. 2013
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.”
de la Fuente LM, Stertzer SH, Argentieri J, Penaloza E, Miano J, Koziner B, Bilos C, Altman PA. Transendocardial autologous bone marrow in chronic myocardial infarction using a helical needle catheter: 1-year follow-up in an open-label, nonrandomized, single-center pilot study (the tabmmi study). Am Heart J. 2007;154:79 e71-77
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