Houston, Texas-based SpinalCyte, LLC, released new data from an ongoing study of the cellular treatment of degenerative disc disease.
According to the company, CybroCell, which is an off-the-shelf allogenic human dermal fibroblast (HDF) injection, improved disc height and reduced pain 12 months in patients with degenerative disc disease (DDD).
The company said, “The trial assessed patients using the Oswestry Disability Index (ODI), Visual Analogue Scale (VAS) and disc height via MRI scans. Using composite scoring, 54% of the treatment arm patients met all three endpoints as compared to only 17% with the placebo saline injection. Over 84% of patients in the treatment group of CybroCell or CybroCell with platelet rich plasma (PRP) injections had an increase or no change in disc height compared to 25% for the placebo saline injection.”
“Verification of structural improvements via MRI at 6- and 12-months strongly suggests that we are inducing a biological cascade of events associated with the induction of a regenerative process in the patient,” said Jesus Perez, M.D., principal investigator of the clinical trial and a member of the Intercoastal Medical Group in Sarasota, Florida. “Based on the clinical observations, imaging studies and patient testimonies, I believe that CybroCell is a breakthrough in the treatment of DDD.”
“The MRI image study demonstrates that a single injection of CybroCell leads to persistent structural and functional improvement in patients with DDD over a year,” said SpinalCyte Chief Scientific Officer Thomas Ichim, Ph.D. “To my knowledge, the pain and MRI data are clearly superior to all other reported cell therapy trial data for DDD. Developing solutions which target and treat the source of chronic pain for patients with DDD, a population which today accounts for about 50% of prescription opioid usage, has implications in combating the opioid epidemic.”
SpinalCyte Chief Executive Officer Pete O’Heerontold OTW, “I think we were all pleased with the positive response to the treatment arm and the sustained benefit over 12 months. When you go into a study like this, you think you have an idea of efficacy, but you really can’t predict the long-term sustainability of that. I would say the long-term positive impact was one of our best moments in this clinical trial.”
“Our product will offer a minimally invasive cell therapy option to traditional hardware remedies for degenerative disc disease. More than just treating the chronic condition, we are regenerating the disc while relieving their debilitating pain. This will have a dramatic impact on opioid use for chronic back pain patients.”
Where the is the radiographic proof?