Year 1
Major milestones for year 1 set by the California Institute for Regenerative Medicine were met.
A cell manufacturing and quality control process was established to generate cell banks that would be safe and suitable for clinical work.
The cells passed all established laboratory criteria to measure potency in repairing tissue and treating arthritis
SCORE submitted an application to the FDA for a pre-pre-IND meeting. (IND = Investigational New Drug) An IND application is required to get the FDA’s approval on preclinical testing before embarking on clinical trials. The pre-pre-meeting with the FDA is scheduled for Aug 11 2016.
The first preclinical (rabbit) experiments were initiated.