VIA Disc Nucleus Pulposus Older Patients Pilot

NCT ID: NCT05412277

Last Updated: 2024-04-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-17
• Study Completion Date: 2024-12-31

Brief Summary

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

Detailed Description

The study will include adult subjects, ages 65 years and older, with symptomatic lumbar intervertebral disc degeneration that is not adequately resolved by non-surgical standard care.

Each subject will receive one injection per each affected level (max of 3 levels) and be evaluated for efficacy and safety during the 6 month observation period. The study is expected to be completed within 18 months, inclusive of enrollment and follow-up for all subjects.

Subjects will be evaluated at baseline and followed through 6 months to establish safety and efficacy of the treatment. The expected duration of subject participation from screening/enrollment through final follow-up is 26 weeks

Conditions

Degenerative Disc Disease; Low Back Pain; Disc Degeneration

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VIA Disc NP

HCT/P: VIA Disc Nucleus Pulposus Allograft

Group Type: OTHER

VIA Disc Nucleus Pulposus Allograft

Intervention Type: 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.

Interventions

VIA Disc Nucleus Pulposus Allograft

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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:

1. History including low back pain aggravated with coughing, sneezing, and increase of abdominal pressure

2. 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:

1. oral pain medication (analgesics, steroids and/or non-steroidal anti-inflammatory drugs [NSAIDs]),

2. structured physical therapy or exercise program prescribed by physical therapist, chiropractor provider or physician specifically for the treatment of low back pain

3. epidural steroid injections and/or facet injections/selective nerve blocks

• An MRI demonstrating:

1. 1 to 3 vertebral level involvement L1-S1

2. Modified Pfirrmann Grade 3-7

3. No Modic changes or if changes ≤ 2

• Oswestry Disability Index (ODI) score at time of evaluation of ≥ 21 and ≤ 80 points
• Low back pain of Baseline Numeric Rating Scale (NRS) score of ≥ 5 on the 11-point scale
• No signs or symptoms of current infection
• Be able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study
• Be willing and able to comply with all study procedures and availability for the duration of the study with a life expectancy of > 2 years

Exclusion Criteria

• 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:

1. Contained disc protrusion >5 mm or disc extrusion, or spondylolisthesis >5 mm (lysis and degenerative);

2. Seronegative spondyloarthropathy;

3. Symptomatic spinal stenosis (moderate to severe in degree);

4. Chronic facet syndrome;

5. Spondylodiscitis;

6. Bilateral spondylolysis;

7. Current or history of osteoporotic or tumor-related vertebral body compression fracture;

8. 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;
• Received any lumbar intradiscal treatment injection or procedure (e.g., injection of methylene blue, dextrose, glucosamine, and chondroitin sulfate, or biacuplasty) and any nerve ablation procedures at the same or adjacent level (e.g., Basivertebral nerve ablation, dorsal ramus or sinovertebral nerve ablations). Discography and anesthetic discography may be performed but must be done at least 2 weeks or more prior to the injection procedure;
• History of lumbar facet joint steroid injections within 4 weeks of procedure;
• History of radiofrequency ablation within 8 weeks of procedure;
• Been a recipient of prior stem cell/progenitor cell therapy or other biological intervention (e.g., PRP) to repair the target intervertebral disc;
• Severe motor deficit or cauda equina disorder based on investigator determination;
• Diagnosis of any traumatic neurological disorders;
• Severe diseases of any other major body system as judged by the investigator, including malignant diseases of any solid organ or any hematologic malignancy during the previous 5 years;
• Demonstrate 3 or more Waddell's signs of Inorganic Behavior;
• Any mental instability, bipolar disorders, post-traumatic stress disorder (PTSD) or uncontrolled anxiety/depression and/or require new or changed anti-depressants or anti-psychotic medications within 3 months of enrollment;
• Compensated injuries or ongoing litigation regarding back pain/injury, or financial or other incentives to remain impaired;
• Any medical condition that impairs follow-up (i.e., fibromyalgia, rheumatoid arthritis, chronic regional pain syndrome, reflex sympathetic dystrophy);
• Evidence of substance abuse (including marijuana); Note: subjects using prescribed extended-release narcotics (e.g., fentanyl patch, MS Contin, oxycontin) within the 3 months prior to screening; subjects on long-acting opioids may be given option to wean off opiates before enrollment. Subjects on short-acting opiates (e.g., hydrocodone, oxycodone, tramadol, etc.) may be included and utilization monitored after the treatment;
• Are currently receiving treatment with radiation, chemotherapy, immunosuppression, or chronic steroid therapy (prednisone, or its equivalent, use of up to 5 mg/qd is allowed, as well as inhalation steroids for asthma);
• Non-MRI compatible devices and active implantable devices, such as spinal cord stimulators, intrathecal pumps, etc.
• Bilateral spondylolysis at any level;
• Fracture of the spine, previous lumbar spine surgery or previous treatment of the target disc(s)

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VIVEX Biologics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nomen Azeem, MD

Role: PRINCIPAL_INVESTIGATOR

Florida Spine & Pain Specialists

Locations

Florida Spine & Pain Specialists

Tampa, Florida, United States

Southern Pain and Spine Associates

Newnan, Georgia, United States

Paradigm Spine Care & Interventional Pain

Slidell, Louisiana, United States

Center for Clinical Research

Winston-Salem, North Carolina, United States

Precision Spine Care

Tyler, Texas, United States

Countries

United States

Other Identifiers

VIA-2022-001

Identifier Type: -

Identifier Source: org_study_id