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EternaLife Cell-Based Therapeutics FAQs

Eterna’s production partner for the development and manufacturing of our cell-based therapeutics strictly adheres to international requirements for cell product preparation. This ensures the quality and safety of all cells and cell-derived products prepared for patient treatment. Their facilities have intensive environmental monitoring of particulates and contaminants, and they employ careful temperature, humidity, and pressure control to optimize cell preparation conditions.

The production partner works with healthy, unvaccinated donors who provide umbilical cord tissue for stem cell harvesting. Mesenchymal stem cells are extracted from the Wharton’s jelly component of the umbilical cord tissue. These cells are then culture expanded in a temperature, humidity and pressure controlled environment. This process allows us to obtain substantial quantities of research-grade cells, which then further undergo meticulous testing for particulates and pathogenic contaminants such as mycoplasma and mold.

The cells are culture-expanded to a maximum of three passages before they are finally cryopreserved. The term “passages” refers to the number of times cells have undergone culture expansion. With each expansion, there is a progressive degradation of the cells’ genetic quality. In contrast to other stem cell providers, who typically employ 6-8 passages, our production partner strictly adheres to a limit of three passages for each batch. After reaching the 3rd passage, the cells undergo flash freezing with liquid nitrogen and are stored at -196 degrees Celsius until our patients are ready to receive treatment.

After stem cells are released from cryopreservation after transport, their viability between 95-99% is ensured through a controlled thawing process and immediate transfer to a nutrient-rich culture medium. This medium provides essential nutrients and support for the cells, helping them recover from the cryopreservation process. These cells maintain their viability for up to 72 hours post-thaw, allowing for the preservation of high cell viability for various clinical applications.