SpinalCyte Applies with FDA to Expand Human Clinical Trial of CybroCell™ Dermal Fibroblasts as Investigational New Drug (IND)
Published: Apr 12, 2018
- 83 percent of CybroCell patients according to MRI imaging, demonstrated increased disc height or no change in one or more discs compared to only 66 percent of control patients.
- More than half (52 percent) of CybroCell-treated discs on MRI showed either increased disc height or no change (a clinically relevant outcome) versus only 38 percent of control discs.
- The administration of CybroCell appears to be safe and well tolerated with no adverse events associated with the cell product.
“The future treatment for degenerative disc disease is most assuredly cell therapy,” said SpinalCyte Chief Scientific Officer Thomas Ichim, Ph.D. “SpinalCyte has demonstrated its CybroCell product shows significant promise as a long-term therapy and cure.”
Over 50 percent of patients treated with CybroCell in the trial reported significant therapeutic improvement. Preclinical animal studies demonstrated that intradiscal injection of CybroCell resulted in a 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.
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 from a simple skin biopsy, researchers believe this trial will advance the clinical translation of fibroblasts into other areas of regenerative medicine.
About SpinalCyte, LLC
Based in Houston, Texas, SpinalCyte, LLC is a regenerative medicine company developing an innovative solution for spinal nucleus replacement using human dermal fibroblasts. Currently, SpinalCyte holds 25 U.S. and international issued patents and has filed for an additional 48 patents pending. Funded entirely by angel investors, SpinalCyte represents the next generation of medical advancement in cell therapy. Visit www.spinalcyte.com.
Source: SpinalCyte, LLC