SpinalCyte received FDA Investigational New Drug clearance for CybroCell, its fibroblast-based therapy to treat degenerative disc disease.
Here are five things to know:
1. The FDA clearance is believed to be the first IND approval for a fibroblast cell therapy in a chronic condition outside of dermatological uses.
2. SpinalCyte can now begin recruiting and screening patients its next CybroCell clinical trial. The trial will start after the first production run is tested to meet the FDA's quality and safety criteria.
3. According to SpinalCyte CEO Pete O'Heeron, the IND clearance represents the company's biggest step to commercialization.
4. The phase 1/phase 2 CybroCell trial assessed pain and structural improvements in patients using the Oswestry Disability Index, Visual Analogue Scale and MRI scans. More than half — 54 percent — of patients who received CybroCell met all three endpoints compared to 17 percent of the placebo group. All patients in the treatment group had an improvement in VAS scores.
5. CybroCell is the first off-the-shelf allogenic human dermal fibroblast product to treat degenerative disc disease.