VIA Disc NP for Back Pain

Recruiting at 22 trial locations

Overseen By Monica Unger

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VIVEX Biologics, Inc.

Disqualifiers: Pregnancy, Previous VIA Disc NP, others

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

Compensation: Varies

Number of Visits: 5

Duration: 1 day

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial observes the effectiveness of the VIA Disc NP treatment, an injection for back issues, in individuals who have already received it. The researchers aim to track outcomes and care patterns to assess the treatment's long-term effects. Participants must have received the VIA Disc NP injection within the last 90 days and be comfortable completing questionnaires. The trial seeks individuals willing to share their experiences. As a Phase 4 trial, this research helps understand how the FDA-approved treatment benefits more patients, offering participants a chance to contribute to broader knowledge.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that VIA Disc NP is safe for patients?

Research shows that VIA Disc NP is designed to help people with damaged spinal discs by adding extra tissue. The tissue used in this treatment comes from donors who undergo careful screening and testing to meet strict safety standards set by the FDA and the American Association of Tissue Banks (AATB), ensuring the donor tissue is safe.

Regarding treatment tolerance, promising evidence exists. One study found that patients reported significant improvement in back function after receiving VIA Disc NP. Initially, 82% of participants had severe back problems, but this dropped to 18% after 24 months.

The treatment uses processed human donor tissue, which may sometimes be exposed to Gentamicin, an antibiotic. However, safety checks ensure it is safe for use. No major safety concerns have been reported, making VIA Disc NP a well-tolerated option for people with back issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for back pain, which often involve medications, physical therapy, or surgery, VIA Disc NP is a novel approach that involves injecting a specially formulated material directly into the affected spinal disc. This treatment is unique because it uses a regenerative medicine technique, aiming to restore and repair the damaged disc tissue rather than just alleviating symptoms. Researchers are excited about VIA Disc NP because it has the potential to provide a minimally invasive solution that addresses the root cause of the pain, offering hope for long-term relief without the need for more invasive procedures.

What evidence suggests that VIA Disc NP is effective for treating patients?

Research has shown that VIA Disc NP, which participants in this trial may receive, may help treat back pain caused by disc wear and tear. One study found that 64% of participants felt much better, with more than half experiencing less back pain over two years. This treatment involves an injection that aims to restore the damaged disc material in the spine. Early studies indicate that this single injection is practical and can help ease symptoms in people with lower back disc issues. These findings suggest that VIA Disc NP could be a good option for those suffering from this type of back pain. ^{1 4 6 7 8}

Who Is on the Research Team?

Jasmine Wilson

Principal Investigator

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Are You a Good Fit for This Trial?

Inclusion Criteria

I am willing and able to follow the study rules and sign the consent form.

I received a VIA Disc NP injection within the last 3 months.

I can read, speak English, and fill out forms by myself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive Vivex VIA Disc NP injection as treatment

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

4 visits (in-person) at 1, 3, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• VIA Disc NP

How Is the Trial Designed?

Group I: VIA Disc NP Experimental Treatment 1 Intervention

Patients meeting study criteria receiving Vivex VIA Disc NP injection as treatment

Who Is Running the Clinical Trial?

VIVEX Biologics, Inc.

Lead Sponsor

Trials

10

Recruited

1,100+

Moxie Clinical

Collaborator

Trials

1

Recruited

500+

Citations

1. 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).

2. 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 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06778447

Study Details | NCT06778447 | Clinical Trial Evaluating the ... VIA Disc NP is a non-surgical intervention intended to supplement nucleus pulposus tissue in degenerated intervertebral discs. This is a randomized, ...

4. 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 ...

5. vivex.com vivex.com/vivex-biologics-inc-completes-subject-enrollment-for-its-ascend-trial-evaluating-via-disc-np-for-symptomatic-disc-degeneration/

Vivex Biologics, Inc. Completes Subject Enrollment for its ... Vivex Biologics, Inc. Completes Subject Enrollment for its ASCEND Trial Evaluating VIA Disc NP™ for Symptomatic Disc Degeneration.

6. viadiscnp.com viadiscnp.com/

VIA Disc NP: HOME The VIA Disc NP procedure is intended for patients who have experienced tissue loss within their lumbar intervertebral discs.

7. vivex.com vivex.com/wp-content/uploads/2021/10/VIA-Disc-NP-Sales-Sheet.pdf

VIA Disc NP Tissue donors are thoroughly screened and tested to meet or exceed safety standards mandated by the FDA and AATB. As with any processed human donor tissue, VIA ...

8. vivex.com vivex.com/wp-content/uploads/2022/10/VIV1300_VIADiscNP_Brochure_Pages_092722.pdf

VIA Disc NP is the first and only nucleus pulposus ( ... Tissue donors are thoroughly screened and tested to meet or exceed safety standards mandated by the FDA and AATB. VIA DISC NP may be exposed to Gentamicin or ...