SpinalCyte’s CybroCell Dermal Fibroblasts signals positive Phase 1/2 Clinical Trial Results

Degenerative disc disease has long been considered an inseparable part of aging but new breakthrough research from SpinalCyte suggests a new cell-based therapy could provide a cure for millions of sufferers. SpinalCyte has completed the first double blind, placebo-controlled human trial using HDF injections to treat sufferers of degenerative disc disease.The company is based out of Texas-based regenerative medicine company focused on regrowth of the spinal disc nucleus using human dermal fibroblasts (HDFs).

Almost 70 percent of patients who were treated with the first off-the-shelf allogeneic HDF product for treatment of degenerative disc disease, called CybroCell, reported significant therapeutic improvement. Prior research has shown 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.

Source: SpinalCyte

SpinalCyte Chief Scientific Officer Thomas Ichim, Ph.D claimed  “The current data suggests that CybroCell has the ability to significantly reduce pain, improve patient quality of life and be more effective than conventional stem cells. It has the added benefit of being more economical to produce and easier to acquire. Compared to all of the stem cells that I have worked with in my career, fibroblasts used in CybroCell are much superior.”

Pete O’Heeron, Chief Executive Officer, SpinalCyte said “Chronic lower back pain effects nearly 33 million Americans and over 7 million are related to degenerative disc disease 2. This creates a national crisis for their quality of life. Our human trials exceeded our most optimistic projections and we believe it will ultimately lead to a cure for degenerative disc disease. On behalf of everyone at SpinalCyte, I would like to thank the patients and physicians who participated in our Phase 1/Phase 2 trial and let them know we are committed to advancing this novel approach so all patients can benefit.”

Phase 1/2 trial included 16 patients with chronic lower back pain caused by degenerative disc disease. The patients were randomly assigned to one of three groups. The first group received a placebo in the form of saline only; the second group received a single intradiscal injection of 10 million cells of CybroCell and the third group received a single intradiscal injection of 10 million cells of CybroCell in combination with platelet-rich plasma.

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