A non-surgical, injectable treatment option from Vivex for sufferers of chronic lower back pain brought about by degenerative disc disease has shown significant improvements in patients, according to a recently published study.
The initial clinical trial results of regenerative medicine company Vivex Biologics’s VAST Trial for VIA Disc have been published in The International Journal of Spine Surgery.
The paper reveals the 12-month results from a level 1 intradiscal study for treating patients with one or two level symptomatic degenerative disc disease. VIA Disc is a non-surgical, injectable treatment option for patients suffering from chronic lower back pain resulting from the disease.
The paper, VAST Clinical Trial: Safely Supplementing Tissue Lost to Degenerative Disc Disease, by Beall, et al, reported initial results from the 24-patient safety cohort of Vivex’s VAST Trial evaluating the safety and performance of VIA Disc.
Data demonstrate that VIA Disc improved pain and function in patients with degenerative disc disease by more than 70%, as measured by the visual analog scale (VAS) and Oswestry Disability Index (ODI), and that these improvements were durable one-year after the procedure.
“I am highly encouraged by the initial results and safety data from the VAST study. Implantation of disc tissue allograft can be done safely, and early evidence suggests greater than 70% improvements in VAS and ODI sustained at 12 months in the allograft groups,” said Dr Douglas Beall, Chief of Radiology Services at the Clinical Radiology of Oklahoma and principal investigator of the VAST study. “Interventions like VIA Disc have the potential for treating mild-to-moderate degenerative discs that greatly advance an alternative to surgical intervention.”
Lower back pain is the most expensive occupational disorder in the US and is the leading cause of disability globally. Degenerative disc disease is a major factor contributing to this disability and is the most common etiology of chronic lower back pain in adults. Low back and neck pain in the US were the third-largest conditions of spending in 2013, with estimated healthcare spending of $87.6 billion. Today, there are limited treatment options, including progression to opioids and surgery for patients who fail non-surgical management.
To address this gap in the continuum of care, Vivex developed VIA Disc to offer patients a novel, non-surgical intervention for treating one to two levels of symptomatic degenerative disc disease.
Peter Wehrly, Chief Executive Officer of Vivex, stated: “These results provide further validation of the therapeutic potential VIA Disc may offer patients in critical need of innovative solutions for degenerative disc disease. Leveraging our expertise around naturally sourced treatment options, our team developed VIA Disc to maximise the regenerative powers of the body to provide patients with a minimally invasive option that provides lasting relief. The early evidence from the VAST study suggests VIA Disc is able to deliver meaningful and durable pain relief, restore function and improve quality of life. We look forward to continuing to build this important clinical body of evidence.”
The VAST Trial is a prospective, randomised, parallel-arm, multicentre study approved to enroll up to 220 subjects at up to 15 clinical sites. Outcomes of the trial were based on assessment of primary and secondary endpoints of six and 12 months after transplant of supplementary allograft compared with placebo or sustained conservative care in subjects who had discogenic pain attributable to disc degeneration as judged by magnetic resonance imaging scoring, physical examination and subject-reported pain.
Source: Vivex
