VIA Disc NP for Degenerative Disc Disease

(RESTORE Trial)

Recruiting at 1 trial location

Overseen By Jasmine Wilson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VIVEX Biologics, Inc.

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

Disqualifiers: Lumbar surgery, Uncontrolled diabetes, Substance abuse, others

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

Compensation: Varies

Number of Visits: 25

Duration: 1 day

496 Participants Needed

Trial Summary

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 using prescribed extended-release narcotics, you may need to wean off them before enrolling. Short-acting opiates may be allowed, but their use will be monitored after treatment.

Is VIA Disc NP safe for humans?

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

How is the VIA Disc NP treatment different 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 like fusion surgery that aim to stabilize the spine. This approach may help restore the disc's natural function and reduce stress on adjacent discs, potentially preventing further degeneration. ^{3 6 7 8 9}

What is the purpose of this trial?

VIA Disc NP is a non-surgical intervention intended to supplement nucleus pulposus tissue in degenerated intervertebral discs. This is a randomized, sham-controlled, multi-center, double-blind clinical trial with an open label roll-in period of one participant per site in which participants with lumbar discogenic pain associated with DDD will receive one VIA Disc NP treatment to each affected level (up to 2 levels). Participants enrolled after the roll-in stage will be randomized on a 2:1 basis to receive either a single VIA Disc NP intradiscal injection at 1 or 2 levels or the sham procedure at 1 or 2 levels. At 12 months, participants in the sham arm with continued symptoms may cross-over, receive VIA Disc NP, and will restart the study visit schedule, completing an additional 12 months of follow-up post-cross-over.

Eligibility Criteria

This trial is for adults aged 22-85 with early to moderate degenerative disc disease causing chronic low-back pain, unresponsive to at least 3 months of conservative care. Participants must have specific levels of pain and disability, be intolerant to sitting for over 30 minutes, and commit to the study's duration with a life expectancy over 2 years.

Inclusion Criteria

I have had chronic lower back pain for over 6 months, not relieved by 3 months of standard treatment.

I am between 22 and 85 years old.

ODI score of ≥ 40 to ≤ 80

Exclusion Criteria

Evidence of dynamic instability on lumbar flexion-extension radiographs

Non-MRI compatible devices and active implantable devices such as spinal cord stimulators, intrathecal pumps, etc.

Received VIA Disc NP previously

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose, intradiscal delivery of 100mg of VIA Disc NP to each affected level

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Multiple visits over 24 months

Treatment Details

Interventions

• VIA Disc NP

Trial Overview VIA Disc NP is being tested as a non-surgical treatment for lumbar discogenic pain due to intervertebral disc degeneration. This single-arm study involves one treatment per affected level (up to two) in subjects who meet the criteria.

Participant Groups

Group I: VIA Disc NP Experimental Treatment 1 Intervention

A single dose, intradiscal delivery of 100mg of VIA Disc NP mixed with sterile saline according to product Instructions for Use (IFU) and administered at up to two affected levels, L1-S1.

Group II: Sham Placebo Group 1 Intervention

The procedure will be identical to the investigational procedure with the following exception: A 20G spinal needle will be carefully inserted through the skin and muscle of the back but WILL NOT penetrate the annulus fibrosus of the intervertebral disc. No saline or VIA Disc NP will be injected.

Who Is Running the Clinical Trial?

VIVEX Biologics, Inc.

Lead Sponsor

Trials

10

Recruited

1,100+

Findings from Research

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]

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 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]

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]

The study analyzed national trends in surgical treatments for lumbar degenerative disc disease in the United States over a 9-year period from 2000 to 2009, highlighting changes in surgical approaches and patient demographics.

Findings indicate a significant increase in surgical interventions during this period, suggesting a growing reliance on surgical options for managing lumbar degenerative disc disease among patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fusion surgery for lumbar degenerative disc disease: still more questions than answers. Deyo, RA.[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]

References

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

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

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

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

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

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

4. 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]

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

Mechanical testing of a novel hydrogel nucleus replacement implant. [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. Germany pubmed.ncbi.nlm.nih.gov

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

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

Fusion surgery for lumbar degenerative disc disease: still more questions than answers. [2022]

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

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