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Biologic Implant

VIA Disc NP Allograft for Degenerative Disc Disease

N/A
Recruiting
Led By Nomen Azeem, MD
Research Sponsored by Vivex Biomedical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Low back pain of Baseline Numeric Rating Scale (NRS) score of ≥ 5 on the 11-point scale
Discogenic low back pain diagnosis based on history and physical exam criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1, 3 and 6 months
Awards & highlights

Study Summary

This trial is testing a new, non-surgical way to treat degenerated intervertebral discs.

Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
While specific side effects are not listed here, similar procedures may include risks such as infection at the injection site, allergic reactions to materials used in the allograft or mild discomfort following the procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lower back pain is moderate to severe.
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I have been diagnosed with discogenic low back pain.
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I currently do not have any signs or symptoms of an infection.
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I have tried at least 2 non-surgical treatments for 6 months without success.
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My back pain affects my daily life but I'm not completely disabled.
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I cannot sit comfortably for long periods.
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My spine issue affects 1 to 3 levels between L1 and S1.
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I have had lower back pain for 6 months or more.
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I have moderate back pain due to disc degeneration in up to 3 discs between L1 and S1.
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I am between 65 and 80 years old.
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I have had lower back pain for 6 months or more.
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I experience pain when I bend over while sitting or standing.
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I have low back pain that worsens with coughing, sneezing, or sitting.
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I've tried at least 2 treatments without surgery for 6 months without success.
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I have received epidural steroid injections or nerve blocks for pain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1, 3 and 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1, 3 and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Patient self-reporting of Functional Efficacy with no change in neurological status using the Oswestry Disability Index (ODI)
Review of all Adverse Events for Safety of treatment and product
Secondary outcome measures
Magnetic Resonance Imaging (MRI) review to determine disc health changes
Morphine Milligram Equivalents (MME) change
Neurological status change
+6 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: VIA Disc NPExperimental Treatment1 Intervention
HCT/P: VIA Disc Nucleus Pulposus Allograft

Find a Location

Who is running the clinical trial?

Vivex Biomedical, Inc.Lead Sponsor
5 Previous Clinical Trials
10,285 Total Patients Enrolled
VIVEX Biologics, Inc.Lead Sponsor
7 Previous Clinical Trials
10,785 Total Patients Enrolled
Nomen Azeem, MDPrincipal InvestigatorFlorida Spine & Pain Specialists

Media Library

VIA Disc NP (Biologic Implant) Clinical Trial Eligibility Overview. Trial Name: NCT05412277 — N/A
Degenerative Disc Disease Research Study Groups: VIA Disc NP
Degenerative Disc Disease Clinical Trial 2023: VIA Disc NP Highlights & Side Effects. Trial Name: NCT05412277 — N/A
VIA Disc NP (Biologic Implant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05412277 — N/A
Degenerative Disc Disease Patient Testimony for trial: Trial Name: NCT05412277 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total number of people taking part in this research?

"Researchers conducting this clinical trial need 35 participants that match the pre-determined inclusion criteria. The study is being conducted at Southern Pain and Spine Associates in Newnan, Georgia as well as the Center for Clinical Research in Winston-Salem, North carolina."

Answered by AI

Are there any vacancies in this clinical trial for prospective participants?

"This clinical trial, as reflected on clinicaltrials.gov, is still looking for participants. The study was originally posted on December 15th 2022 and the last update was November 15th of the same year."

Answered by AI

Who meets the requirements for participation in this research study?

"This study seeks to enroll 35 patients that suffer from intervertebral disc degeneration and are between the ages of 65 and 75. In order to qualify, applicants must meet the following requirements: Be aged 65 years to 75 years old; have a Body mass index (BMI) ≤ 35; have moderate radiographic degeneration of up to 3 intervertebral discs from L1 to S1, with chronic low back pain suspected to be associated;; have Chronic LBP for ≥ 6 months; have a history including low back pain aggravated with coughing, sneezing, and increase of abdominal pressure OR physical exam pain with"

Answered by AI

Can people who are middle-aged participate in this research?

"The age parameters for this study state that eligible participants must be between 65 and 75 years old."

Answered by AI

Are many research facilities participating in this trial throughout the US?

"There are 10 sites running this study, such as Southern Pain and Spine Associates in Newnan, Center for Clinical Research in Winston-Salem, and OMNI Pain & Precision Medicine in Utica."

Answered by AI

What are the main goals of this trial?

"The sponsor of this clinical trial, Vivex Biomedical, Inc., reports that the primary outcome will be pain self-reporting using the NRS (Numerical Rating Scale) over a 3-month period. Additionally, the study will measure secondary outcomes including pain self-reporting (Changes in Numeric Rating Scale scores), ODI score change, and Morphine milligram change."

Answered by AI

Who else is applying?

What state do they live in?
Wisconsin
Louisiana
North Carolina
Other
How old are they?
65+
What site did they apply to?
OMNI Pain & Precision Medicine
The Center for Clinical Research
Rush University
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
0
2
3+

Why did patients apply to this trial?

I am looking for some kind of non invasive treatment for addressing disc issue.
PatientReceived 2+ prior treatments
I feel like treatment to date has not been effective in treating my lower back pain.
PatientReceived 1 prior treatment
scheduled for surgery. but did not have it because the pain was less the day prior to surgery.
PatientReceived 2+ prior treatments
I have tried numerous medications, physical therapy and injection but have not obtained relieve.
PatientReceived 1 prior treatment
I have had 3 RFA's and a BVN ablasion as well as having tried several medications without reliefl.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

How long does screening take and everything about this clinical trial? Can you reach out to my DO for necessary records? Also, when does the trial begin?
PatientReceived 2+ prior treatments

How responsive is this trial?

Most responsive sites:
  1. Rush University: < 48 hours
Typically responds via
Email
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Via Disc Nucleus Pulposus Older Patients Pilot
2023. "Via Disc Nucleus Pulposus Older Patients Pilot". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05412277.
All > Low Back Pain > Degenerative Disc Disease
~8 spots leftby Aug 2024
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