VIA Disc NP for Degenerative Disc Disease

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen byDouglas Beall, MD

Age: 18+

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, a tissue injection for repairing damaged spine discs, in adults whose condition hasn't improved with usual treatments. The injection aims to support and heal the damaged discs, potentially reducing pain and improving function.

Eligibility Criteria

This trial is for adults over 18 with chronic lower back pain due to moderate disc degeneration in the lumbar spine, who haven't improved after trying at least two conservative treatments like pain meds or physical therapy. Participants should have a BMI under 35 and be able to follow the study's procedures for its duration.

Inclusion Criteria

Your body mass index (BMI) is less than 35.

I have tried at least 2 treatments for my back pain without success in the last 3 months.

My eligibility is based on my overall health and specific cancer details.

+20 more

Exclusion Criteria

I have no allergies or conditions that prevent me from receiving sedation or anesthesia.

You have certain spinal conditions, received specific treatments, have certain medical conditions, or are undergoing certain treatments that prevent you from participating in the study.

I am allergic to VIA Disc NP, Gentamicin, or Vancomycin.

+1 more

Participant Groups

VIA Disc NP, an allograft supplementing nucleus pulposus tissue in degenerated discs, is being tested. The goal is to see if it can help alleviate symptoms of degenerative disc disease by providing additional support within the spinal structure.

1Treatment groups

Experimental Treatment

Group I: VIA Disc Nucleus Pulposus AllograftExperimental Treatment1 Intervention

A single dose, intradiscal injection of 100mg of VIA Disc NP mixed with 2ml sterile saline administered to the affected 1 or 2 levels, L1-S1.