ReGelTec’s Hydrafil Injectable Hydrogel Studied to Treat Low Back Pain Caused by Degenerative Disc Disease
June 8, 2022
According to the Society of Interventional Radiology (SIR), a small study showed an experimental formulation of a hydrogel injected into spinal discs was safe and effective in substantially relieving chronic low back pain caused by degenerative disc disease (DDD).
Hydrogels have been used for a number of years to treat DDD, but the current study is the first test of the second-generation Hydrafil hydrogel (ReGelTec, Inc.) in humans, noted SIR.
After 6 months, all patients in the study (N = 20) reported significantly less low back pain—declining from an average self-reported pain level of 7.1 down to 2.0 on a scale of zero to 10. The patients also experienced greatly improved physical function, with average scores falling from 48 to 6 on a questionnaire to gauge the impact of low back pain in preventing patients from the ability to perform normal activities.
The presentation, “Treatment of Painful Lumbar Degenerative Disc Disease: A Feasibility Study” by Douglas P. Beall, MD, et al, will be delivered at the SIR 2022 annual scientific meeting held June 11-16 in Boston, Massachusetts.
In the SIR press release, Dr. Beall commented, “If these findings are confirmed in further research, this procedure may be a very promising treatment for chronic low back pain in those who’ve found insufficient relief from conservative care. The gel is easy to administer, requires no open surgery, and is an easy procedure for the patient.” Dr. Beall is Chief of Radiology Services at Clinical Radiology of Oklahoma in Edmond, Oklahoma. He is also a medical advisor to ReGelTec, Inc.
In 2020, Hydrogel received FDA Breakthrough Device designation. The designation allows expedited review when early evidence suggests an experimental product may provide more effective treatment than current options for treating a serious condition, noted SIR.
As summarized in the SIR press release, the study investigators enrolled 20 patients, aged 22 to 69 years, with chronic DDD low back pain. Each described their pain as four or higher on the 10-point scale. None had found more than mild relief from conservative care, which includes rest, analgesics, physical therapy, and back braces.
The patients were sedated for the procedure, and the gel was heated to become a thick liquid. Guided by fluoroscopic imaging, the investigators used a 17-gauge needle to inject the gel directly into the affected discs. The gel filled in cracks and tears, adhering to the disc’s center and outer layer.
“We really have no good treatments for DDD, aside from conservative care,” stated Dr. Beall. “Surgery is statistically no more effective than conservative care and can potentially make things worse; nerve ablation is appropriate for only a few patients; and existing hydrogels are inserted through an incision as a soft solid, which can pop out of place if you’re not highly skilled in placing it. Because this gel is injectable, it requires no incision, and it augments the whole disc, restoring its structural integrity, which nothing we have currently can do.”