Viable Disc Allograft Supplementation in Patients With Chronic Low Back Pain (VAST Trial): 36-Month Interim Results of an Open-Label Extension Study Purpose: Available treatment for discogenic back pain has limited effectiveness and durability. Previously reported at 12 months, clinical improvements in pain and function were achieved in both the investigational allograft and saline groups of the VAST randomized controlled trial. An open-label extension study is in progress. We report results in patients who completed the 36-month follow-up . Materials and methods: The study was conducted in 218 patients with 1- or 2-level lumbar degenerative disc disease and refractory chronic low back pain. At 12 months, patients could continue in an open-label extension study for up to 36 months, with an interim visit at 24 months. In this interim analysis , we assessed the mean change from baseline in VAS and ODI scores and categorical responder status. To minimize confounding, we compared these 36-month data with results from previous time points in this population only. VIVEX Biologics, Inc. sponsored this study and contributed to study design, data monitoring, statistical analysis, and reporting of results, and paid for independent data collection, core laboratory, and EDC services. All authors had full access to the data and were provided with all requested analyses. Results: Nine of 12 sites participated in the extension; Outcome data were entered for 50 patients at 36 months (allograft treated, n = 46; saline treated, n = 4). The population that completed the 36 months within each study arm was similar to the intention-to-treat population in age, sex, race, ethnicity, body mass index, and smoking status. In the allograft-treated group, the change from baseline in VAS score (mean [95% CI]) at month 36 was -35.35 (±25.39). Success rates in the allograft-treated group show that patients continued to have clinically significant benefits over 36 months in both pain and function, with 60% of patients reporting a 50% improvement in pain and more than 70% of patients had a 20 point reduction in ODI on VAS at 36 months. Conclusion: Patients treated with viable disc tissue allograft for degenerated lumbar discs showed sustained clinical benefits 3 years after treatment . This interim analysis suggests that viable disc tissue allograft could be a durable nonsurgical treatment for patients with chronically painful degenerated lumbar discs. |
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A minimally invasive treatment that injects allograft disc tissue into the spine to relieve pain associated with degenerative disc disease provides significant improvement in pain and function over a sustained period, according to new research presented at the Annual Scientific Meeting of the Society of Interventional Radiology in Phoenix.
The treatment, known as viable disc allograft supplementation, injects specialized cells and fluid into a patient’s damaged disc. The cells in the injected fluid encourage the cells of the damaged disc to regenerate with healthy tissue.
"The significant improvement in pain and function is promising for patients living with chronic low back pain, a condition that can have a major impact on a person’s quality of life," said lead author Douglas Beall, MD, FSIR, chief of radiology at Clinical Radiology of Oklahoma. . “Back pain is the leading cause of limited activity and absenteeism from work. “This treatment can help patients return to a normal activity level over a longer period of time.”
Fifty patients at nine sites participated in this three-year voluntary extension of the Randomized Controlled Viable Allograft-Supplemented Disc Regeneration Trial in the Treatment of Patients with Low Back Pain (VAST), with 46 receiving allograft treatment and four receiving saline treatment. The treatment group was similar to the patient population at the start of the trial in terms of age, sex, race, ethnicity, body mass index, and smoking status. Pain levels were assessed using the VAS analogue scale and functionality was measured using the Oswestery Disability Index (ODI).
60% of patients who received allograft treatment for chronic low back pain reported a greater than 50% improvement in pain and 70% of patients reported a greater than 20-point improvement in their ODI scores. No persistent adverse events were reported.
Degenerative disc disease is the leading cause of chronic low back pain, one of the most common medical conditions in the world. It occurs when the discs that cushion the vertebrae of the spine begin to wear out. Because the discs help facilitate movement and flexibility, the condition causes pain and reduces function.
“Existing treatment for chronic low back pain due to degenerative disc disease is often ineffective or the effects are short-lived,” Beall said. “We need better treatments for this condition, as conservative care does not provide the long-term results patients deserve. “Injectable allograft treatment could be the answer for many people.”
The use of allografts could even help decrease opioid use among patients with chronic low back pain, the researchers said, which would be especially significant for younger patients who have years of function and quality of life to look forward to.
The treatment does not require incisions and patients can go home the same day. VIVIEX Biologics, Inc. sponsored this study and Dr. Beall serves as a medical consultant for them.
Abstract #121: Viable disc allograft supplementation in patients with chronic low back pain (VAST Trial): Interim 36-month results of an open-label extension study. D. Beall, I. Fayed. Annual Scientific Meeting, March 4–9, 2023. This abstract can be found at sirmeeting.org after the embargo time.
