VIA Disc NP Pilot for Patients With Symptomatic Degenerated Discs

NCT ID: NCT05201287

Last Updated: 2024-04-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-30
• Study Completion Date: 2024-12-27

Brief Summary

VIA Disc NP is an allograft intended to supplement the nucleus pulposus tissue in degenerated intervertebral discs.

Detailed Description

The study will include adult subjects, ages 18 years or older, with symptomatic lumbar intervertebral disc degeneration that is not adequately resolved by non-surgical standard care. For the purpose of the primary analysis, subjects are considered enrolled in the study once they have signed the informed consent.

Each subject will receive one injection per level (max of 2 levels) and be evaluated for efficacy and safety during the up to 24 month observation period. The study is expected to be completed within 26 months, inclusive of enrollment and follow-up for all subjects.

Subjects will be evaluated at baseline and followed through up to 24 months to establish safety and efficacy of the treatment. The expected duration of subject participation from screening/enrollment through final follow-up is 104 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 Nucleus Pulposus Allograft

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.

Group Type: EXPERIMENTAL

VIA Disc NP

Intervention Type: OTHER

VIA Disc NP is processed from donated cadaveric disc tissue, lyophilized, and micronized to particles.

Interventions

VIA Disc NP

VIA Disc NP is processed from donated cadaveric disc tissue, lyophilized, and micronized to particles.

Intervention Type: OTHER

Other Intervention Names

VIA Disc Nucleus Pulposus Allograft

Eligibility Criteria

Inclusion Criteria

1. Age 18 years or older;

2. Body mass index (BMI) < 35;

3. Documented diagnosis of moderate radiographic degeneration of up to 2 intervertebral discs from L1 to S1, with a suspected associated discogenic chronic low back pain;

4. Chronic LBP for ≥ 6 months;

5. Failed conservative care over the past 3 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, and

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

6. An MRI demonstrating:

1. 1 to 2 vertebral level involvement L1-S1;

2. Modified Pfirrmann Grade 3-7;

3. No modic changes or if changes ≤ 2;

7. Oswestry Disability Index (ODI) score at time of evaluation of ≥ 40 and ≤ 80 points;

8. Low back pain of Baseline Numeric Rating Scale (NRS) score of ≥ 6 on the 11-point scale;

9. No signs or symptoms of current infection;

10. Be able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study;

11. 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

1. Known allergies to Gentamicin, Vancomycin;

2. Contraindications to the proposed sedation/anesthetic protocol;

3. Radicular pain greater than back pain by history or evidence of radicular pain or neurological deficit within the past 6 months. Radicular pain is defined as nerve pain following a dermatomal distribution and that correlates with nerve compression on imaging. Somatic referred pain is allowed;

4. 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;

5. History of sacroiliac (SI) joint pain/injections during the past 3 months or SI joint fusion within the past two years;

6. Received chemonucleolysis or percutaneous treatment of the affected disc prior to the study;

7. History of epidural steroid injections within 1 week prior to study treatment;

8. 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 anaesthetic discography may be performed but must be done at least 2 weeks or more prior to the injection procedure;

9. Been a recipient of prior stem cell/progenitor cell therapy or other biological intervention (e.g., PRP) to repair the target intervertebral disc;

10. Severe motor deficit or cauda equina disorder based on investigator determination;

11. Diagnosis of any traumatic neurological disorders;

12. 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;

13. Demonstrate 3 or more Waddell's signs of Inorganic Behavior;

14. 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;

15. Compensated injuries or ongoing litigation regarding back pain/injury, or financial or other incentives to remain impaired;

16. If female and of child-bearing potential, are pregnant or breastfeeding or a plan to become pregnant or breastfeed in the first 12 months post-treatment;

17. Any medical condition that impairs follow-up (i.e., fibromyalgia, rheumatoid arthritis, chronic regional pain syndrome, reflex sympathetic dystrophy);

18. 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;

19. 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);

20. Active implantable devices, such as cardiac pacemakers, spinal cord stimulators, intrathecal pumps, etc.

21. Bilateral spondylolysis at any level;

22. Fracture of the spine, previous lumbar spine surgery or previous treatment of the target disc.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MCRA

INDUSTRY

Sponsor Role: collaborator

VIVEX Biologics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Douglas Beall, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Radiology of Oklahoma

Locations

California Orthopedics and Spine

Larkspur, California, United States

Source Health

Santa Monica, California, United States

IPM Medical Group

Walnut Creek, California, United States

Cleveland Clinic

Cleveland, Ohio, United States

Clinical Investigations, LLC

Edmond, Oklahoma, United States

Virginia iSpine

Richmond, Virginia, United States

Countries

United States

References

Beall DP, Davis TT, Amirdelfan K, Naidu RK, DePalma MJ, Costandi S, Yoon ES, Fleming JW, Block JE, Mekhail N. Supplemental nucleus pulposus allograft in patients with lumbar discogenic pain: results of a prospective feasibility study. BMC Musculoskelet Disord. 2025 May 1;26(1):437. doi: 10.1186/s12891-025-08701-0.

Reference Type: DERIVED

PMID: 40312677 (View on PubMed)

Other Identifiers

VIA-2021-001

Identifier Type: -

Identifier Source: org_study_id