Products in the pipeline – Aastrom’s Ixmyelocel-T

by Alexey Bersenev on October 17, 2014 · 0 comments

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This is second post of the series Products in the Pipeline. In this series I’ll provide publicly available information about therapeutic products – candidates for commercialization by cell therapy industry companies. Please leave your feedback and propose cell products to cover!

Today I’m going to analyze Ixmyelocel-T manufactured by Aastrom

Product candidate name: Ixmyelocel-T
Developer: Aastrom Biosciences (Vericel Corporation)
History of development: Company founded in 1989. Product in development >10 years. Phase 1 studies started ~2005, Phase 2 in 2007
Type of cells: human autologous, multicellular, expanded ex vivo
Tissue source: Bone marrow aspirate (~ 50 mL)
Processing steps: Mononuclear cell (MNC) isolation by gradient centrifugation (using Sepax, Biosafe), ex vivo expansion of MNC in proprietary bioreactor (media includes animal serum) for ~12 days, harvest (including enzymatic digestion and wash), final formulation as fresh concentrated product (final volume = 10 mL)
Shelf life: 72 hours
Storage in hypothermic solution (HypoThermosol + Isolyte + HSA)
Cellular composition: (1) Expanded ~200-fold M2 CD14+ macrophages, (2) expanded ~50-fold mesenchymal stromal cells. The rest – all types of bone marrow cells: (3) hematopoietic CD45+ cells – myeloid (granulocytes, monocytes, myeloid progenitors), lymphoid (T cells, B cells, NK, lymphoid progenitors)
CD90 + CD14 cells compose >98% of product
Phenotypic characterization: positive for: CD90, CD105, VEGFR1/2, CD14, CD45, CD163, CD206, CD11b
Release criteria: number of viable cells: 35-295 millions, viability by trypan blue >70%, positivity for CD90 (~20%) and CD45 (~80%) by flow cytometry
Proposed mechanisms of action: Immunomodulatory, anti-inflammatory, stimulation of angiogenesis, trophic/ paracrine.
Administration: Intramuscular, intracardiac – multiple injections
Key publications:
Circulation Research doi: 10.1161/CIRCRESAHA.115.304554
Molecular Therapy doi:10.1038/mt.2012.52
Stem Cell Res Ther doi:10.1186/scrt345
Stem Cell Res Ther doi:10.1186/scrt117
List of publications on CLI and on DCM
Trials: Ongoing – ixCELL DCM
List of completed trials
Analaysis of failure Phase 3 REVIVE trial
Results of trials: RESTORE-CLI, IMPACT-DCM and Catheter-DCM.
Key patents:
Mixed cell populations for tissue repair – WO 2008054825 A2, EP 2314300 B1
Mesenchymal stromal cell populations – WO 2012159042 A1
Bioreactor for mammalian cell growth – WO 1996040860 A1

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