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.

“It’s clear that enabling Rhode Island students to more affordably enter the primary care field, and supporting them once they make that choice, is both feasible and necessary,” Lauria said.

URI President Marc Parlange, also the commission’s co-chairman, said the medical school would be a “natural and strategic extension” of URI’s work. “It would help address Rhode Island’s primary care shortage while strengthening our state’s economy,” he said in a statement.

Lauria said the commission is calling for the state to provide $20 million in “initial seed funding” for the medical school in the state budget for fiscal year 2027, and $22.5 million in annual state funding beginning in 2029, when the first class of students would arrive. The commission also recommended the General Assembly create “a dedicated, recurring budget line to support ongoing medical school planning, accreditation, and initial operational activities.”

In an October report, the Tripp Umbach consulting firm told the commission the school’s start-up costs would total $175 million, and the commission called for exploring federal grants, a direct state budget appropriation, and a statewide bond referendum.

The consultants projected the medical school would be financially stable by its third year of operation, with costs offset by tuition revenue, clinical partnerships, and research growth. And the consultants projected the school would end up generating $196 million in annual economic activity, support about 1,335 jobs, and contribute $4.5 million in annual state and local tax revenue.

During a Rhode Map Live event in June, some officials called the medical school proposal a distraction from addressing the immediate need to provide more financial support and to improve the shortage of primary care doctors.

“In terms of the problem we face today, that won’t fix it,” Attorney General Peter F. Neronha said at the time. “As the head of Anchor [Medical Associates] said to me when I talked to him, that’s like telling the patient that the inexperienced doctor will be with you in a decade.”

But Lauria said the Senate is pursing short-term, medium-term, and long-term solutions to the shortage of primary care doctors, and the medical school is a long-term solution.

In the short term, Lauria said legislators pushed to speed up a Medicaid rate review aimed at boosting reimbursements for primary care doctors. And she noted the Senate passed legislation prohibiting insurers from requiring prior authorization for medically necessary health care services.

Lauria, who is a primary care nurse practitioner, said Rhode Island is lagging behind other states in Medicaid reimbursement rates. For example, she said, she practices medicine in East Greenwich, but if she did so 23 miles away Massachusetts, she could make 20 percent to 30 percent more.

Senate President Valarie J. Lawson, an East Providence Democrat, noted if the Legislature doesn’t act now on a public medical school, it might be having the same conversation in a decade, she said.

Lawson said her own primary care doctor is retiring at the end of March. “We know that we need to recruit physicians here and we need to retain them,” she said.

The commission report acknowledged that a URI medical school would not solve the state’s primary care problem. “Educating more clinicians is necessary but not sufficient for increasing supply,” the report states.

Doctors tend to stay where they train, so Rhode Island must have a plan to produce more primary care doctors through a residency strategy that incentivizes training more primary care doctors and trains them in places such as community health centers, the report states. Appropriate payment for primary care, reduced administrative burdens for clinicians, and lower uninsured rates could also be considered.

The commission called for creating a Primary Care Commission “to ensure continued focus on achieving a primary care–oriented system of care.” The commission also called for the development of a scholarship program linked to a minimum five-year obligation to local primary care practice.

The commission voted 15-0 in favor of the report. Senator Thomas J. Paolino, a Lincoln Republican on the commission, said, “The importance of this issue cannot be understated. My colleagues and I continually hear from constituents frustrated by skyrocketing healthcare costs, severe workplace shortages, and especially limited access to primary care.”

The commission began its work in 2024 when then-Senate President Dominick J. Ruggerio named 21 people to the panel. In February 2025, the Joint Committee on Legislative Services approved $150,000 for a feasibility study. Tripp Umbach made a presentation on its draft of the report in May.

Edward Fitzpatrick can be reached at edward.fitzpatrick@globe.com. Follow him @FitzProv.