VIA Disc NP Allograft for Degenerative Disc Disease

Not currently recruiting at 11 trial locations

Overseen By Nomen Azeem, MD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Vivex Biomedical, Inc.

Must not be taking: Antidepressants, Antipsychotics, Long-acting opioids

Disqualifiers: Radicular pain, Allergies, Severe diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests VIA Disc NP, a non-surgical treatment for degenerative disc disease, which causes chronic low back pain. The goal is to determine if this treatment can improve disc health in the spine by supplementing the nucleus pulposus, the gel-like substance at the center of the discs. Individuals who have experienced chronic low back pain for at least six months, worsened by activities like coughing or sneezing, and have not found relief through other treatments might be suitable candidates. As an unphased trial, it provides an opportunity to explore a new treatment option for chronic low back pain.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on long-acting opioids, you may need to wean off them before enrolling. Short-acting opioids can be continued but will be monitored after treatment.

What prior data suggests that VIA Disc NP is safe for treating degenerative disc disease?

Research shows that VIA Disc NP, a treatment for degenerative disc disease, is safe. Studies have found that this non-surgical treatment, which helps repair worn-out spinal discs, is generally well-tolerated. One study found that most people did not experience serious side effects, indicating a good safety record.

Another study reported that patients experienced less pain and improved movement a year after receiving VIA Disc NP, suggesting it is not only safe but also effective. For those considering joining a trial for VIA Disc NP, current research supports its safety in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for degenerative disc disease, which often include pain medications, physical therapy, or even surgery, VIA Disc NP offers a novel approach. This treatment uses a nucleus pulposus allograft, which involves transplanting healthy disc tissue into the damaged disc. Researchers are excited because this could potentially restore the disc's natural cushioning ability, offering a more regenerative solution rather than just symptom management. This approach is particularly promising as it aims to address the root cause of the degeneration, potentially leading to long-lasting relief and improved spinal health.

What evidence suggests that VIA Disc NP is effective for degenerative disc disease?

Research has shown that VIA Disc NP, a non-surgical treatment under study in this trial, can help people with degenerative disc disease. Studies found that 64% of patients experienced more than a 50% reduction in back pain after receiving this treatment. This relief lasted for at least 24 months, offering promising long-term comfort. The treatment adds new tissue to the spine's discs, which often wear down with this condition. Overall, VIA Disc NP is considered safe for patients. ^{1 2 3 6 7}

Who Is on the Research Team?

Nomen Azeem, MD

Principal Investigator

Florida Spine & Pain Specialists

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My lower back pain is moderate to severe.

Be able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study

I currently do not have any signs or symptoms of an infection.

Exclusion Criteria

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

You have medical devices that are not safe for MRI scans or that are still working inside your body.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one injection per affected level and are evaluated for efficacy and safety

6 months

Baseline visit, followed by evaluations at 1, 3, and 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• VIA Disc NP
• VIA Disc Nucleus Pulposus Allograft

Trial Overview

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.

How Is the Trial Designed?

Group I: VIA Disc NP Experimental Treatment 1 Intervention

HCT/P: VIA Disc Nucleus Pulposus Allograft

Who Is Running the Clinical Trial?

Vivex Biomedical, Inc.

Lead Sponsor

Trials

6

Recruited

390+

VIVEX Biologics, Inc.

Lead Sponsor

Trials

10

Recruited

1,100+

Published Research Related to This Trial

A new preclinical ovine model for studying intervertebral disc degeneration (IDD) was developed, which allows for testing regenerative strategies while keeping the annulus fibrosus intact, thus avoiding damage during the process.

The model demonstrated varying degrees of degeneration based on different surgical treatments, providing a structured way to evaluate the safety and efficacy of new therapies for nucleus pulposus regeneration, with clear grading similar to established systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel stepwise model of intervertebral disc degeneration with intact annulus fibrosus to test regeneration strategies. Vadalà, G., Russo, F., De Strobel, F., et al.[2019]

In a study involving eight rabbits with experimentally induced disc degeneration, it was found that the annulus fibrosus (AF) showed a significant decrease in resistance to delamination, being 27% lower compared to nonpunctured discs from the same animals.

The results indicate that treatments for degenerative disc disease should focus not only on rehydrating or regenerating the nucleus pulposus (NP) but also on repairing and strengthening the AF to maintain its integrity and ability to contain the NP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disc degeneration reduces the delamination strength of the annulus fibrosus in the rabbit annular disc puncture model. Gregory, DE., Bae, WC., Sah, RL., et al.[2021]

The NeuDisc nucleus replacement implant demonstrated superior resistance to bulging and maintained its mechanical properties after extensive fatigue testing, indicating its potential effectiveness as a substitute for the degenerated nucleus pulposus in treating discogenic pain.

In cadaveric tests, the NeuDisc implant showed strong performance under various loading conditions, with high resistance to failure, suggesting it could safely withstand the stresses experienced in the spine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanical testing of a novel hydrogel nucleus replacement implant. Bertagnoli, R., Sabatino, CT., Edwards, JT., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12044970/

Supplemental nucleus pulposus allograft in patients with ...

The results of this study provide additional evidence that supplementation of the degenerated intervertebral disc with intradiscally delivered ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06778447

Study Details | NCT06778447 | Clinical Trial Evaluating the ...

Study Overview. VIA Disc NP is a non-surgical intervention intended to supplement nucleus pulposus tissue in degenerated intervertebral discs.

3.

viadiscnp.com

viadiscnp.com/wp-content/uploads/2024/12/24-133-Block-PROOF.pdf

Nucleus Pulposus Allograft Supplementation in Patients ...

Conclusions: These pilot findings demonstrate the feasibility of treating patients with symptomatic lumbar disc degeneration with a single intradiscal injection ...

4.

viadiscnp.com

viadiscnp.com/data-driven-results/

Data Driven Results

NRS: 64% of participants achieved a substantial clinical benefit (SCB) with >50% improvement in back pain at 24 months (p<0.001).

5.

ijssurgery.com

ijssurgery.com/content/early/2025/10/28/8808

Safety Evaluation of Intradiscal Delivery of Nucleus ...

Conclusions Intradiscal NP allograft supplementation for symptomatic degenerative disc disease demonstrates a favorable safety profile.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7188098/

VAST Clinical Trial: Safely Supplementing Tissue Lost to ...

This study is supported by data demonstrating that improved pain and function at 12 months can be attained with a supplemental viable disc matrix.

7.

trialfinder.panfoundation.org

trialfinder.panfoundation.org/en-US/trial/listing/536542

ASCEND: A Clinical Trial to Evaluate the Safety and ...

VIA Disc NP is an off-the-shelf minimally processed human nucleus pulposus tissue allograft intended to supplement degenerated ...