VIA Disc NP for Degenerative Disc Disease

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

35 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

Is VIA Disc NP safe for humans?

The safety data from a clinical trial for a similar treatment, NOVOCART Disk plus, showed that it was generally safe with no significant immune reactions or harmful effects observed. The trial reported a low rate of adverse events, similar to those expected after elective disk surgery, suggesting a relatively low risk for patients. ^{1 2 3 4 5}

How does the VIA Disc NP treatment differ from other treatments for degenerative disc disease?

VIA Disc NP is unique because it focuses on the biological regrowth of the nucleus pulposus (the soft center of the disc), which is different from traditional treatments that often involve fusion or mechanical stabilization. This approach aims to restore the disc's natural function and integrity, potentially offering a more natural and less invasive solution compared to surgical options. ^{1 6 7 8 9}

Research Team

Douglas Beall, MD

Principal Investigator

Clinical Radiology of Oklahoma

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The biomechanics of a multilevel lumbar spine hybrid using nucleus replacement in conjunction with fusion. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

Mechanical testing of a novel hydrogel nucleus replacement implant. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Screening for nuclear replacement candidates in patients with lumbar degenerative disc disease. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Novel stepwise model of intervertebral disc degeneration with intact annulus fibrosus to test regeneration strategies. [2019]

5. Germany 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Disc degeneration reduces the delamination strength of the annulus fibrosus in the rabbit annular disc puncture model. [2021]

7. Korea (South) pubmed.ncbi.nlm.nih.gov

Clinical Efficacy of Selective Focal Ablation by Navigable Percutaneous Disc Decompression Device in Patients With Cervical Herniated Nucleus Pulposus. [2020]

8. Czech Republic pubmed.ncbi.nlm.nih.gov

[Dynamic neutralization using the Dynesys system for treatment of degenerative disc disease of the lumbar spine]. [2016]

9. Germany pubmed.ncbi.nlm.nih.gov

Plain film evaluation of degenerative disk disease at the lumbosacral junction. [2022]