Treatment for Intervertebral Disc Degeneration

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
OMNI Pain & Precision Medicine, Utica, NY
Intervertebral Disc Degeneration+3 More
Eligibility
65+
All Sexes
What conditions do you have?
Select

Study Summary

VIA Disc NP is a non-surgical intervention intended to replace nucleus tissue in degenerated intervertebral discs.

Eligible Conditions

  • Intervertebral Disc Degeneration
  • Low Back Pain
  • Disc Degeneration

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Other trials for Intervertebral Disc Degeneration

Study Objectives

3 Primary · 9 Secondary · Reporting Duration: baseline, 1, 3 and 6 months

3-6 months
Patient self-reporting of Function
Patient self-reporting of Pain
Patient self-reporting of Pain in low back
baseline - 6 months
Magnetic Resonance Imaging (MRI) review to determine disc health changes
Promis-29 score change
baseline and 6 months
Oswestry Disability Index (ODI) score change
baseline to 3 months
Patient self-reporting of Functional Efficacy with no change in neurological status using the Oswestry Disability Index (ODI)
Patient self-reporting of pain measured by Numerical Rating Scale (NRS)
baseline to 6 months
Review of all Adverse Events for Safety of treatment and product
Month 6
Neurological status change
Month 6
Numeric Rating Scale change
baseline-6 months
Morphine milligram change

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Intervertebral Disc Degeneration

Trial Design

0 Treatment Group

35 Total Participants · 0 Treatment Group

Primary Treatment: Treatment · No Placebo Group · Phase 4

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 1, 3 and 6 months
Closest Location: OMNI Pain & Precision Medicine · Utica, NY
Photo of new york 1Photo of new york 2Photo of new york 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Intervertebral Disc Degeneration
0 CompletedClinical Trials

Who is running the clinical trial?

Vivex Biomedical, Inc.Lead Sponsor
5 Previous Clinical Trials
1,303 Total Patients Enrolled
2 Trials studying Intervertebral Disc Degeneration
253 Patients Enrolled for Intervertebral Disc Degeneration
VIVEX Biologics, Inc.Lead Sponsor
6 Previous Clinical Trials
1,303 Total Patients Enrolled
2 Trials studying Intervertebral Disc Degeneration
253 Patients Enrolled for Intervertebral Disc Degeneration
Nomen Azeem, MDPrincipal InvestigatorFlorida Spine & Pain Specialists

Eligibility Criteria

Age 65+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a documented diagnosis of moderate radiographic degeneration of up to 3 intervertebral discs from L1 to S1, with a suspected associated discogenic chronic low back pain.
You have low back pain aggravated by coughing, sneezing, and increase of abdominal pressure
Epidural steroid injections and/or facet injections/selective nerve blocks.
The spinal cord is involved at one or more vertebral levels.
You have a modified Grade 3-7 of the Pfirrmann scale.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.