VIA Disc Nucleus Pulposus Older Patients Pilot

NCT05412277 | Active Not Recruiting

• 1 other identifier: VIA-2022-001
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Degenerative Disc Disease; Low Back Pain; Disc Degeneration

Keywords

low back pain; degenerative disc disease

Outcome Measures

Primary Outcomes (3)

• Patient self-reporting of Functional Efficacy with no change in neurological status using the Oswestry Disability Index (ODI)

  Evaluate the change from baseline in functional disability on the Oswestry Disability Index (ODI) measured from 0 (minimal disability) to 100 (maximal disability). The ODI is 10 categories of function to quantify disability due to low back pain.

  baseline to 3 months

• Review of all Adverse Events for Safety of treatment and product

  Evaluate the incidence of related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events from baseline through the final follow-up visit that are related to treatment and product

  baseline to 6 months

• Patient self-reporting of Pain

  Changes in Numeric Rating Scale (NRS) scores. Eleven point pain scale used for patient self-reporting of back pain, which ranges from 0 (no pain) to 10 (the worst pain imaginable). Analysis at 3 months measuring subjects meeting lower back pain NRS improvement.

  baseline and 3 months

Secondary Outcomes (9)

• Patient self-reporting of Function

  3-6 months

• Patient self-reporting of Pain

  3-6 months

• Patient self-reporting of Pain in low back

  3-6 months

• Oswestry Disability Index (ODI) score change

  baseline and 6 months

• Numeric Rating Scale change

  baseline, and 6 months

Study Arms (1)

VIA Disc NP

OTHER

HCT/P: VIA Disc Nucleus Pulposus Allograft

Other: VIA Disc Nucleus Pulposus Allograft

Interventions

VIA Disc Nucleus Pulposus Allograft OTHER

A single dose, intradiscal injection of 100mg of VIA Disc NP mixed with 2ml sterile saline administered to the affected 1 to 3 levels, L1-S1.

VIA Disc NP

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age 65 years or older
• Body mass index (BMI) ≤ 35
• Documented diagnosis of moderate radiographic degeneration of up to 3 intervertebral discs from L1 to S1, with a suspected associated discogenic chronic low back pain
• Chronic LBP for ≥ 6 months
• Discogenic low back pain diagnosis based on:
• History including low back pain aggravated with coughing, sneezing, and increase of abdominal pressure
• Physical exam including pain with flexion (sitting or standing), and/or sitting intolerance
• Failed conservative care over the past 6 months of at least 2 conservative treatments including:
• oral pain medication (analgesics, steroids and/or non-steroidal anti-inflammatory drugs \[NSAIDs\]),
• structured physical therapy or exercise program prescribed by physical therapist, chiropractor provider or physician specifically for the treatment of low back pain
• epidural steroid injections and/or facet injections/selective nerve blocks
• An MRI demonstrating:
• to 3 vertebral level involvement L1-S1
• Modified Pfirrmann Grade 3-7
• No Modic changes or if changes ≤ 2

You may not qualify if:

• Contraindications to the proposed sedation/anesthetic protocol;
• Radicular pain greater than back pain by history within the past 8 weeks. Radicular pain is defined as nerve pain following a dermatomal distribution and that correlates with nerve compression on imaging. Somatic referred pain is allowed;
• Known allergies to Gentamicin or Vancomycin
• Any of the following conditions at the index level:
• Contained disc protrusion \>5 mm or disc extrusion, or spondylolisthesis \>5 mm (lysis and degenerative);
• Seronegative spondyloarthropathy;
• Symptomatic spinal stenosis (moderate to severe in degree);
• Chronic facet syndrome;
• Spondylodiscitis;
• Bilateral spondylolysis;
• Current or history of osteoporotic or tumor-related vertebral body compression fracture;
• Previous lumbar spine fusion surgery or disc arthroplasty;
• History of sacroiliac (SI) joint pain/injections during the past 1 months or SI joint fusion within the past six months;
• Received chemonucleolysis or percutaneous treatment of the affected disc prior to the study;
• History of lumbar epidural steroid injections within 4 weeks prior to study treatment;

Sponsors & Collaborators

• VIVEX Biologics, Inc.: lead

Study Sites (5)

Florida Spine & Pain Specialists

Tampa, Florida, 33614, United States

Location

Southern Pain and Spine Associates

Newnan, Georgia, 30263, United States

Location

Paradigm Spine Care & Interventional Pain

Slidell, Louisiana, 70458, United States

Location

Center for Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

Precision Spine Care

Tyler, Texas, 75701, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Low Back Pain

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nomen Azeem, MD

  Florida Spine & Pain Specialists

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Up to 35 patients at up to 15 sites will receive treatment.

Study Record Dates

• First Submitted: June 6, 2022
• First Posted: June 9, 2022
• Study Start: October 17, 2022
• Primary Completion: August 30, 2024
• Study Completion: December 31, 2024
• Last Updated: April 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)