New Study: Intra-Discal Injections for DDD Pain Relief

Houston, Texas-based SpinalCyte, LLC has announced updated data from its Phase 2 clinical trial measuring patient outcomes from using intradiscal injections of the company’s HDF [human dermal fibroblast] product CybroCell to treat degenerative disc disease (DDD).

The company is reporting that the patients in the study had sustained pain relief and increased back mobility after 12 months. “The sustained pain relief suggests that there is a regenerative process stimulated by its cell-based therapy, CybroCell,” says the company. “CybroCell is the first off-the-shelf allogeneic HDF product for treatment of degenerative disc disease.”

“The landmark Phase 1/Phase 2 clinical trial included 24 patients with chronic lower back pain caused by DDD. The patients’ pain levels were measured using the Oswestry Disability Index (ODI) and the Visual Analogue Scale (VAS) at 6- and 12-months post-treatment.”

“At 12 months, more than 90% of the treatment group had over a 10-point reduction in ODI and 100% had improvement in VAS. On average, treatment group patients showed a 59% improvement in ODI scores, compared to the 29% improvement in the placebo group.”

“Patients received intradiscal injections in one to three spinal discs and were randomly assigned to treatment groups that received: a sham saline injection, an injection of 10 million HDFs or an injection of 10 million HDFs in combination with platelet-rich plasma.”

“We are encouraged by the significant pain reduction of the CybroCell patients over the control patients,” said SpinalCyte Chief Scientific Officer Thomas Ichim, Ph.D. “CybroCell has demonstrated clinically relevant outcomes in the area of pain reduction for those patients who received treatment injections.”

Pete O’Heeron, CEO of SpinalCyte, noted, “…This study provides evidence of long-term reduction in pain and quality of life improvement for treated patients. This will ultimately lead to a reduction or elimination in need for opioids for chronic back pain patients and address an urgent national opioid crisis in the U.S.”

O’Heeron told OTW, “We are most encouraged [that] the improvement in the patient pain scores were sustained through 12 months. For the patients living a sedentary life with chronic pain, our treatment has provided relief and allowed them to return to an active, pain-free life. We’ve always felt it would be important to show sustained improvement and we achieved that.”

“We will be working with the FDA on our IND [investigational new drug] application and the necessary regulatory requirements which will lead to extending this treatment to other patients suffering from chronic back pain.”