Injectable Gel May Be Long Term Solution to Chronic Low Back Pain

By Pat Anson

An experimental hydrogel continues to show promise as a long-term treatment for chronic low back pain caused by degenerative disc disease.

Findings from a feasibility study, recently published in the the journal Pain Physician, show that 60 patients with low back pain had significant improvements in physical function, low back pain, and low leg pain a year after Hydrafil gel was injected into their damaged discs.

The gel is heated to liquify it before being injected into cracks and tears in discs. It hardens as it cools, restoring the discs’ structural integrity. The procedure takes about 30 minutes and can be performed as an outpatient procedure under local anesthesia. 

Unlike other cement-like material injected into damaged discs to restore stability, the gel remains flexible and mimics the biomechanical properties of the natural disc, preserving spinal motion. 

Most patients showed significant improvement in their pain and disability scores within one month, and the results were maintained 12 months later. 

“These peer-reviewed results represent an important milestone in the development of the first nucleus augmentation technology for degenerative disc disease,” said Douglas Beall, MD, Chief of Radiology Services at Clinical Radiology of Oklahoma and a medical advisor to ReGelTec, which developed the Hydrafil system. 

“The improvements in pain and function observed at one year, along with an acceptable safety profile, support the continued evaluation of the HYDRAFIL System in the ongoing pivotal study designed to support FDA approval of the device for patients who currently have limited minimally invasive treatment options.”

Five of the 60 patients had increased back and leg pain or numbness, due to the gel partially migrating beyond the injection site. The migrated gel was later removed.

This promotional video by ReGelTec demonstrates how the Hydrafil system works:

ReGelTec is currently recruiting 225 patients in the U.S. and Canada for a new study to assess the Hydrafil system, an important step towards getting FDA approval. 

Hydrafil received the FDA’s breakthrough device designation in 2020, which allows for an expedited review of an experimental product when there is evidence it is more effective than current options.  

Degenerative disc disease is one of the leading causes of chronic low back pain. Healthy discs cushion the spine’s vertebrae, supporting movement and flexibility. But with aging and activity, discs can wear out and cause the bones of the spine to rub together and pinch nerves, causing pain and numbness. By age 60, most people have at least some disc degeneration in their spines.

Current treatments for degenerative discs include physical therapy, anti-inflammatory medication, and analgesics. When those are insufficient, epidural steroid injections and surgical options such as a disc removal or spinal fusion may be considered.

Injection of Donor Cells Gives Long-Term Relief from Degenerative Disc Disease

By Pat Anson, PNN Editor

A single injection of cells and fluid derived from human donor tissue was successful long-term in relieving pain and restoring physical function in patients with degenerative disc disease, according to new research presented at the annual meeting of the Society of Interventional Radiology in Phoenix.

The injections, known as viable disc allograft supplementation, encourage cells in damaged discs to regenerate with healthy tissue. Degenerative disc disease is one of the leading causes of chronic lower back pain.

“The significant improvement in pain and function is promising for patients living with chronic low back pain – a condition that can greatly impact a person’s quality of life,” said lead author Douglas Beall, MD, chief of radiology at Clinical Radiology of Oklahoma. “Back pain is the leading cause of limited activity and workplace absenteeism. This treatment may help patients return to a normal activity level for a longer period time.”

Fifty patients participated in the VAST trial, with 46 patients receiving allograft treatment and four receiving saline injections as a placebo. VIVEX Biologics, a regenerative medicine company that processes donated cells and tissue to treat musculoskeletal injuries, wounds and burns, sponsored the study.

After three years, 60 percent of patients who received allograft treatment reported more than 50% improvement in pain and 70% had significant improvement in their function scores. No patients suffered adverse effects.

In healthy patients, discs cushion the spine’s vertebrae, facilitating movement and flexibility. But discs can wear out over time and cause the bones of the spine to rub together and pinch nerves, causing pain and disability. By age 60, most people have at least some disc degeneration.

“Existing treatment for chronic low back pain due to degenerative disc disease is often ineffective or the effects are short-lived,” said Beall, who is a medical consultant for VIVEX. “We need better treatments for this condition since conservative care is not providing the long-term outcomes that patients deserve. Injectable allograft treatment might be the answer for many people.”

Beall says allograft injections could decrease the use of pain medication by patients with chronic lower back pain. The treatment requires no incisions and patients are able to go home on the same day.

Other companies are also developing new injections to treat degenerative disc disease. In clinical trials, Australia-based Mesoblast says injections of its proprietary stem cell product provided long-term relief for people with lower back pain caused by disc disease. The company recently announced the FDA designated its stem cell injection as a Regenerative Medicine Advanced Therapy, which is designed to help speed up its development.   

Injections of an experimental gel developed by ReGelTec also show promise as a treatment for disc disease. The hydrogel is heated before injection to more easily fill cracks and tears in the affected discs. When the gel cools and hardens, it helps restore the disc’s structural integrity.   

Injectable Gel Shows Promise as Treatment for Back Pain

By Pat Anson, PNN Editor

An experimental gel shows promise as a treatment for low back pain caused by degenerative disc disease (DDD), according to the results of a small study being presented at the annual meeting of the Society of Interventional Radiology in Boston.

Hydrogels have been used for years to treat DDD, but this is the first time that Hydrafil – an injectable gel developed by ReGelTec – has been tested on humans.

Hydrafil was injected into the discs of 20 people in Colombia with chronic DDD, who had average pain levels of 7.1 on a 10-point pain scale. None of the participants had found more than temporary, mild relief from treatments such as rest, analgesics, physical therapy and back braces.

“We really have no good treatments for degenerative disc disease, aside from conservative care,” said lead investigator Douglas Beall, MD, a medical advisor to ReGelTec and chief of radiology services at Clinical Radiology of Oklahoma.

“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 Hydrafil is injectable, it requires no incision and is minimally invasive, although patients are sedated for the procedure. Researchers heat the gel to become a thick liquid and then use a 17-gauge needle to inject it directly into the affected discs, using fluoroscopic imaging to guide them. The gel fills in cracks and tears in the disc, and then hardens, restoring the disc’s structural integrity. The procedure takes about 30 minutes.

This promotional video by ReGelTec demonstrates how Hydrafil works:

Six months after the injection, all 20 participants in the study reported significantly less low back pain, with their pain levels declining to an average of 2.0 on the 10-point pain scale. They also reported significantly better physical function.

“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,” said Beall. “The gel is easy to administer, requires no open surgery, and is an easy procedure for the patient.”

In 2020, Hydrafil received the FDA’s breakthrough device designation, which allows for an expedited review of an experimental product when there is evidence it provides more effective treatment than current options.

ReGelTec is currently recruiting 50 people with DDD in Canada for a new clinical trial of Hydrafil.

Degenerative disc disease is one of the leading causes of chronic low back pain. Healthy discs cushion the spine’s vertebrae, facilitating movement and flexibility. But with activity and normal aging, discs can wear out and cause the bones of the spine to rub together and pinch nerves, causing pain and numbness. By age 60, most people have at least some disc degeneration in their spines.