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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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Degenerative Disc Disease (DDD) include physical therapy, pain management with medications, and surgical interventions such as spinal fusion or disc replacement. Physical therapy aims to strengthen the muscles around the spine, reducing stress on the discs.
Pain management often involves NSAIDs or corticosteroid injections to reduce inflammation and pain. Surgical options like spinal fusion stabilize the spine, while disc replacement aims to maintain spinal mobility.
Treatments like VIA Disc NP, which supplement the nucleus pulposus tissue, focus on restoring the disc's cushioning properties, potentially reducing pain and improving function. This is crucial for DDD patients as it addresses the root cause of pain and degeneration, offering a more targeted and potentially effective treatment option.
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Who is running the clinical trial?
Vivex Biomedical, Inc.Lead Sponsor
5 Previous Clinical Trials
354 Total Patients Enrolled
VIVEX Biologics, Inc.Lead Sponsor
7 Previous Clinical Trials
854 Total Patients Enrolled
MCRAIndustry Sponsor
33 Previous Clinical Trials
9,331 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
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