Degenerative disc disease patients who received intradiscal injections of SpinalCyte's CybroCell showed sustained pain relief improvement and greater back mobility after 12 months, according to the results of a phase 1/2 clinical trial.
Here are five things to know:
1. The trial comprised 24 patients with chronic lower back pain caused by DDD. Patients received intradiscal injections in one to three spinal discs and were randomly assigned to receive a saline injection, an injection of 10 million human dermal fibroblasts or an injection of 10 million HDFs combined with platelet-rich plasma.
2. Patients' pain levels were measured using the Oswestry Disability Index and the Visual Analogue Scale at six- and 12-months postoperatively. After 12 months, more than 90 percent of the CybroCell group had over a 10-point reduction in ODI and 100 percent had improvement in VAS.
3. Patients who received the HDF CybroCell treatment had a 61 percent improvement over baseline ODI scores, compared to a 29 percent improvement in the control group.
4. Among patients in the CybroCell group, 83 percent demonstrated increased disc height or no change in one or more discs compared to 66 percent of control patients. More than half — 52 percent — of CybroCell-treated discs showed either increased disc height or no change compared to only 38 percent of control discs.
5. SpinalCyte's phase 1/2 l is the first allogeneic use of fibroblasts outside of dermatologic conditions.