health day reporter
THURSDAY, June 9, 2022 (HealthDay News) — Like fixing a roadside apartment, a new injectable hydrogel shows promise as a remedy for worn-out intervertebral discs — pumping them up and easing chronic disease Back ache.
The gel, with the brand name Hydrafil, is injected directly into worn discs using X-rays to guide the needle, said lead researcher Dr. Douglas Beall, chief of radiology services at the Oklahoma Radiology Clinic in Edmond. As shown in a pilot study, the gel fills cracks and tears in the spinal disc, adhering to the center and outer layer of the disc.
“It comes in as a heated liquid that cools down and becomes a kind of medium-hard gum consistency,” Beall said. “This creates a sort of Fix-a-Flat, filling the disc and restoring the disc’s biomechanical integrity.”
Twenty patients treated with the gel experienced a 67% reduction in back pain during a one-year follow-up, Beall said.
Patients also experienced an 85% improvement in disability caused by their back pain. Beall said the gel did not cause any harmful reactions in any of the patients.
The bones in your spine – the vertebrae – are separated by rubbery cushions called vertebral discs. These discs act as shock absorbers, preventing the vertebrae from rubbing together and allowing you to move, bend and twist comfortably.
Degenerative disc disease happens as people age. Intervertebral discs tend to dry out and wear down over time. They can also be torn or injured as a result of everyday activities or sports.
According to Beall’s estimates, nearly two-thirds of people with back pain caused by degenerative disc disease could be considered candidates for this hydrogel therapy.
He is due to present these findings Sunday in Boston at a meeting of the Society of Interventional Radiology. Results presented at meetings are considered preliminary until published in a peer-reviewed journal.
Hydrafil has been designated a Breakthrough Device in 2020 by the U.S. Food and Drug Administration, allowing for expedited review when evidence suggests an investigational product may provide more effective treatment for a serious condition compared to options current, the researchers said.
Other hydrogels are already used to treat injured or worn discs, but these products are surgically inserted as a soft solid, “which can slip out of place if you’re not highly skilled in placing it,” Beall said. .
“Because this gel is injectable, it requires no incisions, and it augments the entire disc, restoring its structural integrity, which nothing we currently have can do,” he said.
Dr. J. David Prologo, an interventional radiologist at Emory University School of Medicine in Atlanta, reacted to the findings.
“I don’t think the impact of this study can be overstated – degenerative disc disease is a condition that affects hundreds of millions of people worldwide, for which there really is no definitive treatment other than a big surgery, with all the costs and risks,” he said.
“Dr. Beall is spearheading the ability to literally inject replacement fluid into the disc using only a needle and image guidance, removing the needle after injection and sending the patient home with a replaced disc and a dressing over the puncture site,” said Prologo, who chairs the Society for Interventional Radiology’s pain management/MSK clinical specialty board.
Dr. Alan Hilibrand, co-director of spine surgery at the Rothman Orthopedic Institute in Philadelphia, agreed.
Disc repairs performed by injection are “almost like the holy grail of treating back problems,” he said.
Hilibrand noted that other research groups attempt to repair discs by injecting growth factors or biological agents to promote the regrowth of healthy disc material.
These new results come from what Beall called an early feasibility trial, which was conducted with 20 patients between the ages of 22 and 69 in Colombia. All had a chronic illness low back pain due to degenerative disc disease.
A pilot trial involving more patients is underway in Canada, and based on these results, a large-scale clinical trial will be conducted in the United States.
Hydrogel therapy is new, but builds on existing techniques and skills regularly used by interventional radiologists, surgeons and other specialists, Beall and Prologo said.
“Interventional radiologists already have the skills to perform this procedure,” Prologo said. “Large-scale release is expected to follow FDA approval and US studies replicating its effectiveness. The cost will be several times lower than an open surgical alternative.”
One major question remains, which the full clinical trial should answer: how long will the hydrogel last in a repaired disc?
Beall said Hydrafil was subjected to “repetition stress simulation that simulates 90 years of stress and tension, so hopefully this will be a solution forever.”
But that will need to be demonstrated in real humans over time, Hilibrand said.
Trials will need to show that the gel “can be held in the disc and won’t wear out or leak over time,” he said.
“If something lasts six months or even 12 months, I don’t think we as a society can afford to pay for it,” Hilibrand said. “It may not be very profitable if it only lasts a short time.”
ReGelTec Inc. is the company that developed Hydrafil and paid for this initial feasibility study, Beall said. Beall is the company’s medical advisor.
The Arthritis Foundation has more information on degenerative disc disease.
SOURCES: Douglas Beall, MD, chief, radiology services, Oklahoma Clinic Radiology, Edmond, Okla; J. David Prologo, MD, interventional radiologist, Emory University School of Medicine, Atlanta; Alan Hilibrand, MD, co-director, spine surgery, Rothman Orthopedic Institute, Philadelphia; Society of Interventional Radiology, press briefing, June 8, 2022; Society of Interventional Radiology Annual Scientific Meeting, Boston, June 11-16, 2022