VIA Disc NP Allograft for Degenerative Disc Disease

Recruiting in Palo Alto (17 mi)

+11 other locations

Overseen byNomen Azeem, MD

Age: 65+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Vivex Biomedical, Inc.

No Placebo Group

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.

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.

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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.

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Treatment Details

Interventions

VIA Disc NP (Biologic Implant)
VIA Disc Nucleus Pulposus Allograft (Biologic Implant)

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