pipeline

CardiALLO Cell Therapy System

Where the CardiAMP Cell Therapy System uses a patient’s own cells, the CardiALLO system uses culture-expanded, bone marrow-derived mesenchymal stem cells from a universal donor. This allows the cells to be obtained "off the shelf" from a pharmacy, negating the need for a bone marrow aspirate for the patient and providing an option for patients identified as sub-optimal for the CardiAMP treatment. This “off the shelf” dose, which uses neurokinin-1 receptor positive mesenchymal stem cells, is then processed into a proprietary dosage for delivery with the Helix transendocardial delivery system for the treatment of cardiac and pulmonary disease.

Clinical data co-sponsored by BioCardia has shown that cells from a universal donor (allogenic) do not appear to trigger an immune response in the patient who receives them, and thus may be immune privileged. Clinical results to-date also support that these universal donor cells are safe when delivered using the Helix transendocardial delivery system and may have similar benefits to a patient’s own bone marrow cells.

CardiALLO Cell Therapy

• Cryo-preserved, culture-expanded cells manufactured from universal donor bone marrow sent to hospital and stored
• Cells thawed, washed and released for infusion (2 to 4 hours)
• Cells transported to cath lab
• Cells delivered to patient using Helix transendocardial delivery system ~ 15 minutes
• Patient discharged same day or after overnight stay
  
  

Related Publications:

Florea V, Rieger AC, DiFede DL, El-Khorazaty J, et al. Dose Comparison Study of Allogeneic Mesenchymal Stem Cells in Patients with Ischemic Cardiomyopathy (The TRIDENT Study) CIRC RES, 117, 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

Suncion VY, Ghersin E, Zambrano JP, Karantalis V, Mandel NS, Nelson KH, Fishman JE, Gerstenblith G, Velazquez DLD, Breton E, Schulman IH, Sitammagari K, Johnston PV, Brinker J, Altman P, Mushtaq M, Trachtenberg B, Silva JD, McNiece IK, Lardo AC, George RT, Hare JM, Heldman AW. Does transendocardial injection of mesenchymal stem cells improve myocardial function locally, or globally: An analysis from the POSEIDON trial. Journal of the American College of Cardiology. 2013;61

Hare JM, Fishman JE, Gerstenblith G, DiFede Velazquez DL, Zambrano JP, Suncion VY, Tracy M, Ghersin E, Johnston PV, Brinker JA, Breton E, Davis-Sproul J, Schulman IH, Byrnes J, Mendizabal AM, Lowery MH, Rouy D, Altman P, Wong Po Foo C, Ruiz P, Amador A, Da Silva J, McNiece IK, Heldman AW, George R, Lardo A. Comparison of allogeneic vs autologous bone marrow-derived mesenchymal stem cells delivered by transendocardial injection in patients with ischemic cardiomyopathy: The poseidon randomized trial. JAMA. 2012;308:2369-2379

Trachtenberg B, Velazquez DL, Williams AR, McNiece I, Fishman J, Nguyen K, Rouy D, Altman P, Schwarz R, Mendizabal A, Oskouei B, Byrnes J, Soto V, Tracy M, Zambrano JP, Heldman AW, Hare JM. Rationale and design of the transendocardial injection of autologous human cells (bone marrow or mesenchymal) in chronic ischemic left ventricular dysfunction and heart failure secondary to myocardial infarction (tac-hft) trial: A randomized, double-blind, placebo-controlled study of safety and efficacy. Am Heart J. 2011;161:487-493.

Williams AR, Trachtenberg B, Velazquez DL, McNiece I, Altman P, Rouy D, Mendizabal AM, Pattany PM, Lopera GA, Fishman J, Zambrano JP, Heldman AW, Hare JM. Intramyocardial stem cell injection in patients with ischemic cardiomyopathy: Functional recovery and reverse remodeling. Circ Res. 2011;108:792-796

Amado LC, Saliaris AP, Schuleri KH, St John M, Xie JS, Cattaneo S, Durand DJ, Fitton T, Kuang JQ, Stewart G, Lehrke S, Baumgartner WW, Martin BJ, Heldman AW, Hare JM. Cardiac repair with intramyocardial injection of allogeneic mesenchymal stem cells after myocardial infarction. Proc Natl Acad Sci U S A. 2005;102:11474-11479