Experiencing low back pain? Clinical trial at Brown Health could help.

The injection could be “revolutionary” for treating degenerative disc disease, said the trial’s principal investigator

A clinical trial at Brown University Health to treat chronic low back pain with a one-time, non-surgical injection treatment is seeking to enroll patients in Rhode Island.

The trial is testing whether a single injection of rexlemestrocel-L, an experimental stem cell therapy derived from healthy adult donors, combined with hyaluronic acid, a gel-like substance found in the body’s joints, and delivered directly into the damaged disc, can provide prolonged relief for low back pain.

Low back pain, or degenerative disc disease, can affect quality of life, disrupt daily activities, commission people out of work and have an impact on a person’s mood, said Alexios Carayannopoulos, chief of physical medicine and rehabilitation at Rhode Island Hospital, Newport Hospital and Brown Health Medical Group and the principal investigator in the trial.

The treatment Carayannopoulos is investigating involves an injection without the need for an incision or hardware. While other treatments, such as anti-inflammatory pills, physical therapy or steroid injections, assuage the pain, they don’t treat the underlying issues with the damaged disc. The trial’s injection aims to do more than numb pain: it seeks to change the environment inside the disc, reducing inflammation and potentially slowing or stabilizing disc degeneration, according to Carayannopoulos.

Earlier clinical trials of the injection with over 400 patients “found substantial pain improvements” lasting up to two to three years, according to Carayannopoulos. They also showed signs that the injection slowed disc height loss.

Carayannopoulos reckons the treatment could be “revolutionary” for managing chronic low back pain.

“We have struggled through many years trying to figure out the holy grail for treating back pain,” Carayannopoulos said.

There are surgical options and non-surgical options for treating low back pain. In most cases, the non-surgical options are sought first, but some patients still get unnecessary surgeries, according to Carayannopoulos.

The new treatment could also cut back on the use of opioids, which for some patients can be addictive to the point of overdose. More than half of opioid prescriptions are for low back pain, according to Carayannopoulos.

“If we can identify a treatment that has long-term promise, then we can sort of have a paradigm shift in the way we organize and treat a cohort of patients with degenerative disc pain, which is one of the common contributors to low back pain,” Carayannopoulos said.

Carayannopoulos did not have data on how many people suffer from low back pain in Rhode Island, but based on the number of spine centers in the state and anecdotal evidence, he reckons there is a significant number of people with the condition.

“Part of that comes from some of the legacy of blue-collar work that’s being done, industry stuff, line work that’s still being done, some jewelry business. But the type of stuff that we see is often degenerate, meaning it’s happened over time,” he said.

The trial is funded by Mesoblast, an Australia-based medicine company specializing in inflammatory diseases. It is designed for adults 18 years and older who have experienced chronic low back pain for at least six months, have been diagnosed with degenerative disc disease and have not found relief from other treatment options.

The trial is recruiting participants at Rhode Island Hospital and Newport Hospital. They will not be charged for participating and will be reimbursed for time and travel, according to Brown Health. To inquire about the trial, call 401-793-9177 or fill out a pre-screening information form online.

The trial is in its third phase, where researchers and clinicians are comparing results with a larger group of patients. It will be followed by a fourth phase, which will seek FDA approval to monitor long-term effectiveness and safety.