VIA Disc NP for Degenerative Disc Disease

Not currently recruiting at 4 trial locations

Overseen By Kasra Amirdelfan, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vivex Biomedical, Inc.

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

Disqualifiers: Radicular pain, Osteoporotic fracture, Severe diseases, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called VIA Disc NP, designed to help individuals with chronic low back pain from degenerated spinal discs. VIA Disc NP is injected into the affected discs to potentially relieve pain and improve function. The trial targets individuals who have experienced chronic low back pain for at least six months and have not found relief from treatments such as pain medication or physical therapy. As an unphased trial, it offers patients the opportunity to explore a novel treatment option that might provide relief where other methods have failed.

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 joining the trial. 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 has shown that VIA Disc NP is safe for treating degenerative disc disease. One study found that VIA Disc NP, a tissue graft from a donor, was well-tolerated when injected into the spine. Patients did not report major side effects after receiving the treatment. This treatment helps repair damaged discs, reducing pain and improving movement. Another study found that 64% of participants experienced a significant decrease in back pain within 24 months. These findings suggest that VIA Disc NP is both safe and effective for many patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

VIA Disc NP is unique because it introduces a new approach to treating degenerative disc disease by using a nucleus pulposus allograft. Unlike standard treatments, which often include pain management with medications, physical therapy, or surgical interventions like spinal fusion, VIA Disc NP involves a direct intradiscal injection. This method delivers a single dose of 100mg of VIA Disc NP mixed with sterile saline right into the affected disc levels, which could potentially offer targeted relief and promote disc health. Researchers are excited about this treatment because it directly targets the disc itself, potentially regenerating or repairing the damaged tissue, which could lead to improved outcomes and pain reduction for patients.

What evidence suggests that VIA Disc NP might be an effective treatment for degenerative disc disease?

Research has shown that VIA Disc NP, which participants in this trial will receive, might help treat degenerative disc disease. In previous studies, 64% of participants felt much better, with their back pain reduced by more than half after 24 months. This suggests that the treatment can offer significant benefits for many people. Additionally, the treatment is generally safe. VIA Disc NP works by adding to the nucleus pulposus, the jelly-like center of spinal discs, which may help improve the function of worn-out discs. ^{1 2 4 6 7}

Who Is on the Research Team?

Douglas Beall, MD

Principal Investigator

Clinical Radiology of Oklahoma

Are You a Good Fit for This Trial?

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.

Inclusion 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.

Exclusion Criteria

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

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.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose, intradiscal injection of VIA Disc NP mixed with sterile saline administered to the affected disc levels

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with evaluations at baseline, 3, 6, and up to 24 months

104 weeks

Multiple visits (in-person and virtual)

Observation

Participants are observed for changes in pain, function, and disc health through various assessments including MRI and patient-reported outcomes

6 months

What Are the Treatments Tested in This Trial?

Interventions

• VIA Disc NP

Trial Overview 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.

How Is the Trial Designed?

Group I: VIA Disc Nucleus Pulposus Allograft Experimental Treatment 1 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.

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+

MCRA

Industry Sponsor

Trials

40

Recruited

11,100+

MCRA, LLC

Industry Sponsor

Trials

19

Recruited

7,500+

Published Research Related to This Trial

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]

In a study of 102 patients with degenerative disc disease (DDD) treated with the Dynesys system, significant improvements were observed in pain and functional status over a 36-month follow-up, with average VAS scores decreasing from 7.3 to 4.7 and ODI scores from 54.5 to 39.9.

MRI results indicated that the Dynesys system effectively addressed disc bulging and restored space in the lumbar spinal canal, although it did not promote disc regeneration; nonetheless, it improved the quality of life for patients despite a potential risk of slight disc height reduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Dynamic neutralization using the Dynesys system for treatment of degenerative disc disease of the lumbar spine]. Cienciala, J., Chaloupka, R., Repko, M., et al.[2016]

A study of 100 lumbar MRI scans found that the posterior disk height (PDH) is a reliable measure for diagnosing degenerative disk disease (DDD) at the lumbosacral junction, with specific thresholds indicating the presence or absence of DDD.

Using PDH measurements, a PDH of 5.4 mm or less suggests DDD, while a PDH of 7.7 mm or more indicates no DDD, providing clear diagnostic criteria for radiologists interpreting plain films.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plain film evaluation of degenerative disk disease at the lumbosacral junction. Cohn, EL., Maurer, EJ., Keats, TE., et al.[2022]

In a study of 85 patients with degenerative disc disease, only 40.2% of treated levels were found to have no radiographic contraindications for nuclear replacement, indicating that strict patient selection criteria are necessary for this treatment.

The most common treatment level, L5-S1, had only 21.8% suitability for nuclear replacement, while upper lumbar levels showed higher eligibility, emphasizing the importance of assessing various factors like endplate integrity and BMI before considering this surgical option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening for nuclear replacement candidates in patients with lumbar degenerative disc disease. Pappou, I., Cammisa, F., Papadopoulos, E., et al.[2020]

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]

The study found that a hybrid approach of nucleus replacement (NR) combined with fusion at one level resulted in similar biomechanical performance to a single-level fusion, showing no significant differences in range of motion, stiffness, or intradiscal pressure.

Compared to a traditional two-level fusion, the NR+fusion hybrid allowed for 41.9% more range of motion and produced significantly lower pressures at adjacent levels, suggesting it may lead to fewer complications and more natural spinal function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The biomechanics of a multilevel lumbar spine hybrid using nucleus replacement in conjunction with fusion. Dahl, MC., Ellingson, AM., Mehta, HP., et al.[2013]

The NOVOCART® Disk plus treatment, designed for autologous disk chondrocyte transplantation, has shown to be safe in a Phase I trial with 24 adult patients, as adverse event rates were similar to those expected after standard disk surgery.

No significant immunological issues or harmful effects were observed, indicating that this treatment could be a feasible option for patients with degenerative disk disease, potentially reducing the risk of further degeneration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective randomized multicenter phase I/II clinical trial to evaluate safety and efficacy of NOVOCART disk plus autologous disk chondrocyte transplantation in the treatment of nucleotomized and degenerative lumbar disks to avoid secondary disease: safety results of Phase I-a short report. Tschugg, A., Diepers, M., Simone, S., 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 ...