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
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.
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