The FDA has cleared SpinalCyte’s Investigational New Drug (IND) protocol for CybroCell. This is considered to be the first IND approval for a fibroblast cell therapy in a chronic condition outside of dermatological uses.
The clearance allows SpinalCyte to begin recruiting and screening patients for the study. The trial is to be initiated after the first production run is tested for quality and safety to meet the FDA stated criteria.
The Phase 1/Phase 2 trial assessed pain and structural improvements in patients using the Oswestry Disability Index (ODI), Visual Analogue Scale (VAS) and MRI scans. The data showed that 54% of the treatment arm patients met all three endpoints as compared to only 17% with the placebo (p=0.0003). More than 90% of patients in the treatment group had an over a 10-point reduction in Oswestry Disability Index (ODI), 100% had improvement in Visual Analogue Scale (VAS) and over 84% had an increase or no change in disc height.
Thomas Ichim, SpinalCyte chief scientific officer, considered the long-term impact of the universal donor cell therapy: “The persistent structural and functional improvements we have observed in patients demonstrate that CybroCell has the potential to help combat the opioid epidemic by eliminating chronic pain.”