NIH is providing Arteriocyte with additional grant money to support development of the firm’s Nanex™ stem cell expansion technology for applications in bone marrow transplantation. Arteriocyte is working with collaborators at the Dana Farber Institute and University of Utah to validate the clinical grade GMP process using the Nanex System, and says it hopes to launch a GMP-grade Nanex closed-culture system expansion product within the next year. The firm anticipates getting a device approved by FDA for use in a clinical cell therapy setting by late 2013.
The Nanex platform, combining a scaffold and proprietary culture medium and growth factors, has been designed to mimic the bone marrow niche environment and promote the growth and rapid expansion of hematopoietic stem and progenitor cells, while minimizing loss of stem cell phenotype. The firm says the platform provides an ideal solution to maximizing the numbers of stem cells generated for applications in basic research, drug discovery, screening, and therapeutics.
Arteriocyte’s first product, the NANEX™ Hematopoietic Stem/Progenitor Cell (HSPC) Expansion Kit, is designed specifically for the ex vivo expansion of human bone marrow, peripheral blood, and umbilical cord blood-derived human stem and pluripotent cells. The firm says the kit can be used to expand 100,000 hematopoietic stem cells into 10 million stem and pluripotent (CD34+ cells) within 10 days in serum free culture that requires no media change, and allows enzyme-free easy cell harvesting.