Advanced Pipeline
| Product / Indication | Pre Clinical | Phase 1 | Phase 2 | Phase 3 | Approved |
|---|---|---|---|---|---|
BCDA-01 : CardiAMP Cell TherapyIndication : Ischemic Heart Failure |
Pivotal / Phase III has CMS reimbursement, actively enrolling at 24 U.S. sites |
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BCDA-02 : CardiAMP Cell TherapyIndication : Chronic Myocardial Ischemia with Refractory Angina |
Pivotal / Phase III has CMS reimbursement |
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BCDA-03 CardiALLO Cell TherapyIndication : Ischemic Heart Failure |
Phase 1/2 IND acceptance anticipated Q4 2019 |
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Helix Partner 01: CellProtheraIndication: Acute Infarction |
Funded by Partner |
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Helix Partner-02 : Univ of MilanIndication : Heart Failure |
Funded by partner |
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- CardiAMP – autologous minimally processed bone marrow cells (a patient’s own cells)
- CardiALLO –allogenic culture expanded mesenchymal stem cells derived from bone marrow (donor-derived)
Both programs provide compelling and synergistic approaches to replicating the natural response of bone marrow cells to cardiac injury. CardiAMP harnesses the potential of autologous minimally processed bone marrow cells, using a pre-procedure screening test to identify patients most likely to benefit from the therapy. CardiALLO utilizes younger, universal donor mesenchymal stem cells and may be appropriate for patients who are not optimal candidates for the CardiAMP therapy.
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