2018 has been a difficult, but transformative year for Cells On Ice. In January, our banking partner American Cryostem received a warning letter from the FDA, which requested updates and changes to a number of their internal processes. The legal team for American Cryostem advised the company against releasing any patients’ stored cells prior to making the suggested corrections and receiving approval of their IND (investigational new drug) application from the FDA.
Both American Cryostem and Cells On Ice have been working respectively to address these changes to the lab and its operations and supply the FDA with great safety data, not only from months of laboratory testing, but patient follow ups, up to over 1 year out.
The updates and research data have gone towards improving the bank’s master file, bolstering its IND application, which was just recently resubmitted to the FDA for review. We are hopeful that the FDA will unbiasedly review the new IND application and judge it on its merits and the ample transparent data submitted along with it.
It’s important to note that all cell samples currently banked with Cells On Ice at American Cryostem are safe, sterile and secure.
In the meantime, we are referring all of our patients interested in cell expansion and banking to US Stem Cell, who has provided a terrific service to us and our patients during this time. To learn more and get started, please contact [email protected] .