Apply to Trial

Compensation: Varies

Number of Visits: 1

Duration: 6 months

21 Participants Needed

VIA Disc NP Allograft for Degenerative Disc Disease

Recruiting at 11 trial locations

Overseen ByNomen Azeem, MD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Vivex Biomedical, Inc.

Must not be taking: Antidepressants, Antipsychotics, Long-acting opioids

Disqualifiers: Radicular pain, Allergies, Severe diseases, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This trial tests VIA Disc NP, an injection to repair damaged spinal discs, in adults aged 65+ with back pain not relieved by other treatments. The injection adds material to the damaged discs to improve function and reduce 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.

How is the VIA Disc NP Allograft treatment different from other treatments for degenerative disc disease?

The VIA Disc NP Allograft treatment is unique because it involves injecting an intact nucleus pulposus (the soft center of a spinal disc) into the degenerated disc, which has been shown to effectively slow down disc degeneration without causing immune rejection. This approach is different from other treatments that may not use intact tissue or focus on biological regrowth of the disc's components.¹ ² ³ ⁴ ⁵

Research Team

Nomen Azeem, MD

Principal Investigator

Florida Spine & Pain Specialists

Eligibility Criteria

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

My lower back pain is moderate to severe.

Be able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study

I currently do not have any signs or symptoms of an infection.

See 23 more

Exclusion Criteria

I do not have neurological disorders, mental instability, substance abuse issues, or take specific medications.

You have medical devices that are not safe for MRI scans or that are still working inside your body.

I have had previous issues or treatments on my lower back.

See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one injection per affected level and are evaluated for efficacy and safety

6 months

Baseline visit, followed by evaluations at 1, 3, and 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

VIA Disc NP
VIA Disc Nucleus Pulposus Allograft

Trial OverviewThe VIA Disc NP procedure is being tested as a non-surgical option for older patients with lower back pain caused by disc degeneration. It involves supplementing the nucleus pulposus tissue within the affected intervertebral discs.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: VIA Disc NPExperimental Treatment1 Intervention

HCT/P: VIA Disc Nucleus Pulposus Allograft

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vivex Biomedical, Inc.

Lead Sponsor

Trials

Recruited

390+

VIVEX Biologics, Inc.

Lead Sponsor

Trials

Recruited

1,100+

Findings from Research

A new preclinical ovine model for studying intervertebral disc degeneration (IDD) was developed, which allows for testing regenerative strategies while keeping the annulus fibrosus intact, thus avoiding damage during the process.

The model demonstrated varying degrees of degeneration based on different surgical treatments, providing a structured way to evaluate the safety and efficacy of new therapies for nucleus pulposus regeneration, with clear grading similar to established systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel stepwise model of intervertebral disc degeneration with intact annulus fibrosus to test regeneration strategies.Vadalà, G., Russo, F., De Strobel, F., et al.[2019]

The NeuDisc nucleus replacement implant demonstrated superior resistance to bulging and maintained its mechanical properties after extensive fatigue testing, indicating its potential effectiveness as a substitute for the degenerated nucleus pulposus in treating discogenic pain.

In cadaveric tests, the NeuDisc implant showed strong performance under various loading conditions, with high resistance to failure, suggesting it could safely withstand the stresses experienced in the spine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanical testing of a novel hydrogel nucleus replacement implant.Bertagnoli, R., Sabatino, CT., Edwards, JT., et al.[2022]

In a study involving eight rabbits with experimentally induced disc degeneration, it was found that the annulus fibrosus (AF) showed a significant decrease in resistance to delamination, being 27% lower compared to nonpunctured discs from the same animals.

The results indicate that treatments for degenerative disc disease should focus not only on rehydrating or regenerating the nucleus pulposus (NP) but also on repairing and strengthening the AF to maintain its integrity and ability to contain the NP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disc degeneration reduces the delamination strength of the annulus fibrosus in the rabbit annular disc puncture model.Gregory, DE., Bae, WC., Sah, RL., et al.[2021]