What is the mechanism of action of this treatment?

Common treatments for Degenerative Disc Disease (DDD) include physical therapy, pharmacologic treatments, interventional procedures, and surgical options. Physical therapy aims to strengthen the muscles around the spine, improving support and reducing pain. Pharmacologic treatments, such as non-steroidal anti-inflammatory drugs (NSAIDs), reduce inflammation and pain. Interventional procedures like epidural steroid injections provide targeted pain relief. Surgical options, including spinal fusion and disc replacement, aim to stabilize the spine or replace damaged discs. Treatments like VIA Disc NP, which supplement the nucleus pulposus tissue, work by restoring the disc's cushioning properties, potentially reducing pain and improving function. These mechanisms are crucial for DDD patients as they address the underlying issues of disc degeneration, aiming to alleviate pain and improve quality of life.

What side effects are associated with this type of intervention?

Common treatments for Degenerative Disc Disease that involve interventions similar to nucleus pulposus supplementation include intradiscal injections and radiofrequency denervation. Known side effects of these treatments can include increased pain, transient lower limb numbness, paraesthesias, and superficial burns. Additionally, intradiscal injections may lead to short-term pain relief but often do not provide long-term benefits. Radiofrequency denervation, while potentially reducing pain in the short term, has inconsistent long-term efficacy and may also cause similar adverse effects.

What prior FDA approvals exist?

The FDA has approved various treatments for Degenerative Disc Disease, primarily focusing on pain management and surgical interventions. Commonly approved treatments include non-steroidal anti-inflammatory drugs (NSAIDs), muscle relaxants, and opioids for pain relief. Surgical options like spinal fusion and artificial disc replacement have also been approved. However, treatments specifically involving the supplementation of nucleus pulposus tissue, such as the VIA Disc NP being studied, are relatively novel and not widely represented in prior FDA approvals. These newer treatments aim to restore the disc's natural function and structure, potentially offering a less invasive alternative to traditional surgical methods.

What other types of research exist?

Promising novel alternatives to VIA Disc NP for Degenerative Disc Disease patients include: 1) Mesenchymal Stem Cell (MSC) Therapy: Clinical trials have shown MSCs can promote disc regeneration and reduce pain. 2) Intradiscal PRP (Platelet-Rich Plasma) Injections: PRP has anti-inflammatory properties and can promote healing in degenerated discs. 3) Gene Therapy: Emerging research focuses on gene editing techniques to enhance disc cell function and slow degeneration. 4) Biologic Scaffolds: These are designed to support disc regeneration by providing a structure for new tissue growth.

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Biologic Implant

VIA Disc NP Allograft for Degenerative Disc Disease

N/A

Waitlist Available

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

Must not have

Various medical history and conditions including neurological disorders, mental instability, substance abuse, and ongoing treatment with certain medications

Bilateral spondylolysis, fracture of the spine, previous lumbar spine surgery or previous treatment of the target disc

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1, 3 and 6 months

Awards & highlights

Summary

This trial tests VIA Disc NP, an injection to repair damaged spinal discs, in adults aged 65+ with back pain not relieved by other treatments. The injection adds material to the damaged discs to improve function and reduce pain.

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.

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.

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.

Exclusion Criteria

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

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I do not have neurological disorders, mental instability, substance abuse issues, or take specific medications.

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I have had previous issues or treatments on my lower back.

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

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I have had more leg pain than back pain in the last 8 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1, 3 and 6 months

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

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 (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

0 / 19Eligibility 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, pharmacologic treatments, interventional procedures, and surgical options. Physical therapy aims to strengthen the muscles around the spine, improving support and reducing pain. Pharmacologic treatments, such as non-steroidal anti-inflammatory drugs (NSAIDs), reduce inflammation and pain. Interventional procedures like epidural steroid injections provide targeted pain relief. Surgical options, including spinal fusion and disc replacement, aim to stabilize the spine or replace damaged discs. Treatments like VIA Disc NP, which supplement the nucleus pulposus tissue, work by restoring the disc's cushioning properties, potentially reducing pain and improving function. These mechanisms are crucial for DDD patients as they address the underlying issues of disc degeneration, aiming to alleviate pain and improve quality of life.