SpinalCyte has reported positive 12-month endpoint results from its Phase l/Phase ll clinical trial of CybroCell for treatment of degenerative disc disease (DDD).
Results demonstrated that patients treated with intradiscal injections of CybroCell experienced improvement in pain relief and increased back mobility after 12 months.
Improvement in pain relief shows that CybroCell, a human dermal fibroblast (HDF) based cell therapy, was successful in initiating a regenerative process.
As part of the trial, SpinalCyte enrolled 24 patients with chronic lower back pain caused by DDD.
Patients were treated with intradiscal injections in one to three spinal discs and were randomly distributed to each of treatment groups to receive either a saline injection, or an injection of ten million HDFs or a dose of ten million HDFs in combination with platelet-rich plasma (PRP).
SpinalCyte used the Oswestry Disability Index (ODI) and the visual analogue scale (VAS) to measure the pain levels of the patients at six and 12-months post-treatment.
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At the end of 12-months, it was found that more than 90% of the patients treated with CybroCell had over a ten-point reduction in ODI and full improvement in VAS.
Patients who received CybroCell also showed an average of 61% improvement over baseline ODI scores, compared to a 29% improvement in the placebo group.
Previous MRI data from the six-month endpoint also showed improved results in the patients treated with CybroCell over the control group.
SpinalCyte chief scientific officer Thomas Ichim said: “CybroCell has demonstrated clinically relevant outcomes in the area of pain reduction for those patients who received treatment injections.
“The data suggests CybroCell possesses tangible pain reduction benefits for people suffering from degenerative disc disease, a chronic condition for which previous treatments have not demonstrated a physical improvement in the degenerated disc.”