What side effects are associated with this type of intervention?

Common treatments for Degenerative Disc Disease that involve supplementation of nucleus pulposus tissue, such as intradiscal injections and other interventional therapies, can have several side effects. These may include increased pain, transient lower limb numbness, paraesthesias, and superficial burns. Additionally, there is a risk of infection, bleeding, and nerve damage associated with any invasive procedure. While these treatments aim to alleviate pain and improve function, the adverse events reported in clinical trials highlight the importance of careful patient selection and monitoring.

What prior FDA approvals exist?

The FDA has approved several treatments for Degenerative Disc Disease, primarily focusing on pain management and surgical interventions. Traditional treatments include non-steroidal anti-inflammatory drugs (NSAIDs), physical therapy, and surgical options like spinal fusion and artificial disc replacement. More recently, regenerative approaches such as intradiscal injections of biologic agents, including stem cells and growth factors, have been explored, although these are still largely in experimental stages. The VIA Disc NP trial, which involves the supplementation of nucleus pulposus tissue, represents a novel approach in this category, aiming to restore the disc's natural function and alleviate symptoms.

What other types of research exist?

Promising novel alternatives to VIA Disc NP for Degenerative Disc Disease include: <ol> <li>Intradiscal methylene blue injection, which has shown potential in reducing discogenic pain.</li> <li></li> </ol> Radiofrequency denervation techniques, such as percutaneous intradiscal radiofrequency thermocoagulation, which have been studied for their efficacy in managing chronic discogenic back pain. 3. Intradiscal electrothermal therapy (IDET), which involves applying heat to the affected disc to reduce pain and improve function. 4. Stem cell therapy, particularly the use of mesenchymal stem cells, which are being investigated for their regenerative potential in disc repair.

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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

Must not have

Contraindications to the proposed sedation/anesthetic protocol

Contained disc protrusion >5 mm or disc extrusion, or spondylolisthesis >5 mm, seronegative spondyloarthropathy, symptomatic spinal stenosis, chronic facet syndrome, spondylodiscitis, bilateral spondylolysis, current or history of osteoporotic or tumor-related vertebral body compression fracture, previous lumbar spine fusion surgery or disc arthroplasty, history of sacroiliac (SI) joint pain/injections during the past 3 months or SI joint fusion within the past two years, received chemonucleolysis or percutaneous treatment of the affected disc prior to the study, history of epidural steroid injections within 1 week prior to study treatment, received any lumbar intradiscal treatment injection or procedure, been a recipient of prior stem cell/progenitor cell therapy or other biological intervention, severe motor deficit or cauda equina disorder, diagnosis of any traumatic neurological disorders, severe diseases of any other major body system, demonstrate 3 or more Waddell's signs of Inorganic Behavior, any mental instability, compensated injuries or ongoing litigation regarding back pain/injury, if female and of child-bearing potential, are pregnant or breastfeeding or a plan to become pregnant or breastfeed in the first 12 months post-treatment, any medical condition that impairs follow-up, evidence of substance abuse, currently receiving treatment with radiation, chemotherapy, immunosuppression, or chronic steroid therapy, active implantable devices, bilateral spondylolysis at any level, fracture of the spine, previous lumbar spine surgery or previous treatment of the target disc

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-6 months

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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 below

Select...

I am 18 years old or older.

Select...

I have had lower back pain for 6 months or more.

Select...

My back pain significantly limits my daily activities.

Select...

I've tried at least 2 treatments like pain meds, physical therapy, or injections for my condition without success in the last 3 months.

Select...

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

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.

Select...

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

Select...

I have had severe leg pain or nerve issues more than back pain in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3-6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Magnetic Resonance Imaging

Neurological status change

Numeric Rating Scale change

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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.

0 / 16Eligibility criteria met

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.