VAST Trial Evaluates Injectable Allograft Disc Tissue to Relieve Chronic Back Pain

March 1, 2023—A minimally invasive treatment that injects allograft disc tissue into the spine to relieve pain associated with degenerative disc disease has been shown to provide significant improvement in pain and function over a sustained period, announced the Society of Interventional Radiology (SIR).

In the press release, SIR noted that in degenerative disc disease, the discs that cushion the spine’s vertebra to facilitate movement and flexibility begin to wear away. The condition leads to pain and reduced functionality.

The treatment, known as viable disc allograft supplementation, injects specialized cells and fluid into a patient’s damaged disc. The cells of the injected fluid encourage the cells in the damaged disc to regenerate with healthy tissue. The treatment requires no incisions, and patients are able to go home on the same day as the procedure.

Interim 36-month results from VAST, an open-label extension trial of viable disc allograft supplementation in patients with chronic low back pain by Douglas Beall, MD, et al, are being presented at the SIR annual scientific meeting held March 4-9 in Phoenix, Arizona.

The study was sponsored by Vivex Biologics, Inc., which develops and delivers allograft solutions designed to support the body’s healing and regenerative potential.

As summarized in the SIR press release, 50 patients at nine sites participated in this 3-year voluntary extension of the randomized control VAST trial, with 46 patients receiving allograft treatment and four receiving saline. The treatment group was similar to the patient population at the start of the trial in age, sex, race, ethnicity, body mass index, and smoking status.

Pain levels were evaluated using the visual analog scale, and functionality was measured using the Oswestery Disability Index (ODI).

The investigators found that 60% of patients who received allograft treatment for chronic low back pain reported a > 50% improvement in pain; also, 70% of patients reported more than a 20-point improvement in their ODI scores. There were no persistent adverse events reported.

“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,” commented Dr. Beall in the SIR press release. “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 of time.”

Dr. Beall, Chief of Radiology at Clinical Radiology of Oklahoma in Edmond, Oklahoma, continued, “Existing treatment for chronic low back pain due to degenerative disc disease is often ineffective or the effects are short-lived. 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.”

Additionally, the investigators noted that use of allograft could help decrease opioid use among patients with chronic low back pain, reported SIR in the press release.