SpinalCyte announces MRI evidence of disc regeneration following phase 1/phase 2 clinical trial of CybroCell Dermal Fibroblasts

Fibroblast cells. Fluorescent light micrograph of two fibroblast cells, showing their nuclei (purple) and cytoskeleton. The cytoskeleton is made up of microtubules of the protein tubulin (yellow) and filaments of the protein actin (blue). The cytoskeleton supports the cells structure, allows the cell to move and assists in the transport of organelles and vesicles within the cell. Fibroblasts are cells forming connective tissue, and are responsible for secreting connective tissue proteins such as collagen. Magnification: x980 when printed 10cm wide. Photo credit: Dr. Torsten Wittmann/Science Photo Library/Getty Images

MRI analysis of patients who received intradiscal injections of human dermal fibroblasts shows significant improvement in disc height after six months, the latest evidence from SpinalCyte demonstrates. The company say this suggests there is a quantifiable regenerative process stimulated by its new cell-based therapy, CybroCell, which is the first off-the-shelf allogeneic human dermal fibroblast product for treatment of degenerative disc disease.

The phase 1/phase 2 clinical trial, which is still enrolling, includes 24 patients with chronic lower back pain caused by degenerative disc disease. The patients are randomly assigned to one of three groups, and receive intradiscal injections from one to three discs. The first group receives placebo in the form of saline only; the second group receives ten million human dermal fibroblasts, and the third group receives ten million human dermal fibroblasts in combination with platelet-rich plasma.

Preliminary six-month MRI data on 18 patients has been completed with an independent radiological expert providing MRI analysis. According to this analysis, patients who received CybroCell or CybroCell with platelet-rich plasma demonstrated superior outcomes vs. the control group. Of patients treated with CybroCell, 83% demonstrated increased disc height or no change in one or more discs, compared to only 66% of control patients. More than half (52%) of CybroCell-treated discs showed either increased disc height or no change (a clinically relevant outcome) vs. only 38% of control discs.

SpinalCyte chief scientific officer Thomas Ichim comments, “We are encouraged by the superior radiographic analysis of the CybroCell patients over the control patients. We have demonstrated clinically relevant outcomes which include increased disc height for those patients who received treatment injections.”

This data suggests CybroCell possesses tangible benefits for people suffering from degenerative disc disease, a chronic condition for which previous treatments have not demonstrated a physical alteration in the degenerated disc, the press release states.

Over 50% of patients treated with CybroCell in the trial reported significant therapeutic improvement. Preclinical animal studies demonstrated that intradiscal injection of CybroCell resulted in significant increase in regeneration, disc height, gene expression of structural genes such as collagen type I and collagen type II, and the contents of structural proteins such as proteoglycan, which in turn generate the jelly-like material (disc nucleus) that provides cushioning for the spine.

Pete O’Heeron, CEO of SpinalCyte, says, “This study provides real evidence of pain reduction and disc regeneration at only six months. The CybroCell product has the ability to change the quality of life for these chronically diseased patients and eliminate the need for opioid use in patients suffering from chronic back pain. CybroCell can address an urgent public need and impact the national opioid crisis in the USA.”

SpinalCyte’s phase 1/phase 2 clinical trial is the first allogeneic use of fibroblasts outside of skin conditions. Considering how relatively easy it is to collect large numbers of fibroblasts that would otherwise be disposed of, researchers believe this trial will advance the clinical translation of fibroblasts into other areas of regenerative medicine.



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