VIA Disc NP Allograft for Degenerative Disc Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests VIA Disc NP, a non-surgical treatment for degenerative disc disease, which causes chronic low back pain. The goal is to determine if this treatment can improve disc health in the spine by supplementing the nucleus pulposus, the gel-like substance at the center of the discs. Individuals who have experienced chronic low back pain for at least six months, worsened by activities like coughing or sneezing, and have not found relief through other treatments might be suitable candidates. As an unphased trial, it provides an opportunity to explore a new treatment option for chronic low back pain.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on long-acting opioids, you may need to wean off them before enrolling. Short-acting opioids can be continued but will be monitored after treatment.
What prior data suggests that VIA Disc NP is safe for treating degenerative disc disease?
Research shows that VIA Disc NP, a treatment for degenerative disc disease, is safe. Studies have found that this non-surgical treatment, which helps repair worn-out spinal discs, is generally well-tolerated. One study found that most people did not experience serious side effects, indicating a good safety record.
Another study reported that patients experienced less pain and improved movement a year after receiving VIA Disc NP, suggesting it is not only safe but also effective. For those considering joining a trial for VIA Disc NP, current research supports its safety in humans.12345Why are researchers excited about this trial?
Unlike the standard treatments for degenerative disc disease, which often include pain medications, physical therapy, or even surgery, VIA Disc NP offers a novel approach. This treatment uses a nucleus pulposus allograft, which involves transplanting healthy disc tissue into the damaged disc. Researchers are excited because this could potentially restore the disc's natural cushioning ability, offering a more regenerative solution rather than just symptom management. This approach is particularly promising as it aims to address the root cause of the degeneration, potentially leading to long-lasting relief and improved spinal health.
What evidence suggests that VIA Disc NP is effective for degenerative disc disease?
Research has shown that VIA Disc NP, a non-surgical treatment under study in this trial, can help people with degenerative disc disease. Studies found that 64% of patients experienced more than a 50% reduction in back pain after receiving this treatment. This relief lasted for at least 24 months, offering promising long-term comfort. The treatment adds new tissue to the spine's discs, which often wear down with this condition. Overall, VIA Disc NP is considered safe for patients.12367
Who Is on the Research Team?
Nomen Azeem, MD
Principal Investigator
Florida Spine & Pain Specialists
Are You a Good Fit for This Trial?
This trial is for people aged 65-80 with chronic lower back pain due to degenerative disc disease, who haven't found relief from standard treatments like pain meds and physical therapy. They should have moderate disc degeneration in up to three discs between L1-S1, an ODI score of 21-80 points, a BMI ≤35, no spine fractures or surgeries, and no allergies to certain antibiotics.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive one injection per affected level and are evaluated for efficacy and safety
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- VIA Disc NP
- VIA Disc Nucleus Pulposus Allograft
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vivex Biomedical, Inc.
Lead Sponsor
VIVEX Biologics, Inc.
Lead Sponsor