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Allograft
VIA Disc NP for Degenerative Disc Disease
N/A
Waitlist Available
Led By Douglas Beall, 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
Age 18 years or older
Chronic LBP for ≥ 6 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-6 months
Awards & highlights
Study Summary
This trial is testing a new way to treat degenerated discs without surgery.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include reactions related to implantation such as discomfort at injection site, infection risk, or allergic responses especially if there's a known allergy to components of VIA Disc NP.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I have had lower back pain for 6 months or more.
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My back pain significantly limits my daily activities.
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I've tried at least 2 treatments like pain meds, physical therapy, or injections for my condition without success in the last 3 months.
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My MRI shows 1-2 spinal levels affected between L1-S1 with specific disc conditions.
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I have moderate back pain due to disc degeneration in up to 2 discs between L1 and S1.
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I have moderate back pain due to disc degeneration in my lower spine.
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I have had lower back pain for 6 months or more.
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My lower back pain is severe, scoring 6 or more out of 11.
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I am 18 years old or older.
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I currently have no signs or symptoms of infection.
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I have had lower back pain for 6 months or more.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3-6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-6 months
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
Neurological status change
Numeric Rating Scale change
+5 moreTrial Design
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.
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
MCRAIndustry Sponsor
29 Previous Clinical Trials
9,121 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I am 18 years old or older.I have had lower back pain for 6 months or more.I have no allergies or conditions that prevent me from receiving sedation or anesthesia.My back pain significantly limits my daily activities.I've tried at least 2 treatments like pain meds, physical therapy, or injections for my condition without success in the last 3 months.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.You have a specific type of back pain involving 1 to 2 levels of your spine, with certain MRI findings and a certain level of disability and pain. You are not currently experiencing an infection, and you are able to understand and agree to participate in the study. You are also expected to live for more than 2 years and be available for the study.I have had epidural steroid injections or nerve blocks.My MRI shows 1-2 spinal levels affected between L1-S1 with specific disc conditions.I have moderate back pain due to disc degeneration in up to 2 discs between L1 and S1.I have moderate back pain due to disc degeneration in my lower spine.I am allergic to VIA Disc NP, Gentamicin, or Vancomycin.I have had lower back pain for 6 months or more.My lower back pain is severe, scoring 6 or more out of 11.I am 18 years old or older.Your body mass index (BMI) is less than 35.I currently have no signs or symptoms of infection.I have had severe leg pain or nerve issues more than back pain in the last 6 months.I am taking oral pain medication.I have had lower back pain for 6 months or more.
Research Study Groups:
This trial has the following groups:- Group 1: VIA Disc Nucleus Pulposus Allograft
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Degenerative Disc Disease Patient Testimony for trial: Trial Name: NCT05201287 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this clinical trial currently have open spots for participants?
"According to information shared on clinicaltrials.gov, this trial is no longer looking for participants. First posted in late December 2021 and last edited mid October 2022, the study has ceased recruitment of patients; however, 388 other trials are actively searching for candidates currently."
Answered by AI
What are the anticipated results of this medical investigation?
"As per the protocol set by Vivex Biomedical, Inc., primary outcomes will be gauged from baseline to 3 months and include review of any adverse events incurred. Secondary objectives involve evaluating neurological status changes, return to work rate post-treatment, and patient self-reported pain in the lower back region (measured via an 11 point numeric rating scale running between 0 - no pain up to 10 - worst imaginable)."
Answered by AI
Who else is applying?
What state do they live in?
Texas
Ohio
California
Other
How old are they?
18 - 65
65+
What site did they apply to?
Source Health
Other
California Orthopedics and Spine
Cleveland Clinic
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
2
0
3+
Why did patients apply to this trial?
Disc degeneration shown on MRIs. I'd like to better manage my lower back problems.
PatientReceived 2+ prior treatments
Diclofenac/.homeopathic/essential oils/herbal ..supplements & topical! I've tried PT, oral steroids, pain meds, and injected steroids. No improvement.
PatientReceived 1 prior treatment
Medications, steroidal epidural injections and RF ablation have not been effective.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
How long do screening visits take? What happens afterwards?
PatientReceived no prior treatments
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