SpinalCyte's CybroCell injections led to sustained improvement in clinical study: 5 notes

Biologics

SpinalCyte reported positive 12-month endpoint MRI outcomes in a clinical study of its CybroCell injection for degenerative disc disease.

Here are five things to know:

1. A single injection of the modified human dermal fibroblast CybroCell product led to significant improvements in disc height and pain reduction 12 months later for DDD patients.

2. Researchers evaluated patients using the Oswestry Disability Index, Visual Analogue Scale and disc height via MRI scans. Using composite scoring, 54 percent of patients who received the treatment met all three endpoints compared to only 17 percent of patients who received a placebo saline injection.

3. More than 84 percent of patients treated with CybroCell or CybroCell with platelet rich plasma injections had an increase or no change in disc height compared to 25 percent of the placebo group.

"The MRI image study demonstrates that a single injection of CybroCell leads to persistent structural and functional improvement in patients with DDD over a year," said SpinalCyte Chief Scientific Officer Thomas Ichim, PhD. "To my knowledge, the pain and MRI data are clearly superior to all other reported cell therapy trial data for DDD. Developing solutions which target and treat the source of chronic pain for patients with DDD, a population which today accounts for about 50 percent of prescription opioid usage, has implications in combating the opioid epidemic."

4. SpinalCyte's phase 1/phase 2 clinical trial is the first allogeneic use of fibroblasts outside of dermatologic conditions.

5. CybroCell is the first off-the-shelf allogenic human dermal fibroblast product for DDD treatment.

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