VIA Disc Nucleus Pulposus Older Patients Pilot

Low Back Pain Clinical Trial

Official title:

A Pilot Study Evaluating the Safety and Clinical Effectiveness of Nucleus Pulposus Allograft for Supplementation of Nucleus Pulposus Tissue in Older Patients With Symptomatic Degenerated Discs

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05412277
• Other study ID #: VIA-2022-001
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 17, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: VIVEX Biologics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 21
• Est. completion date: December 31, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Back Pain
• Degenerative Disc Disease
• Disc Degeneration
• Intervertebral Disc Degeneration
• Low Back Pain

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Southern Pain and Spine Associates	Newnan	Georgia
United States	Paradigm Spine Care & Interventional Pain	Slidell	Louisiana
United States	Florida Spine & Pain Specialists	Tampa	Florida
United States	Precision Spine Care	Tyler	Texas
United States	Center for Clinical Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
VIVEX Biologics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Patient self-reporting of Function	Oswestry Disability Index (ODI) is measured 0 (minimal disability) to 100 (maximal disability). This index is comprised of ten categories of function to quantify disability due to low back pain. Functional responder analysis at 3 and 6 months measured as subjects meeting functional improvement of = 10, 15 and 20 points in ODI scores.	3-6 months
Secondary	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 and 6 months measured as subjects meeting lower back pain NRS improvement of 50%.	3-6 months
Secondary	Patient self-reporting of Pain in low back	Changes in Numeric Rating Scale (NRS) scores. Eleven-point pain scale used for patient to self-report level of back pain, which ranges from 0 (no pain) to 10 (the worst pain imaginable). Analysis at 3 and 6 months measured as subjects meeting lower back pain NRS improvement of =30%.	3-6 months
Secondary	Oswestry Disability Index (ODI) score change	Change from baseline in ODI scores at 6 months. Ten category index comprising of function to quantify due to low back pain. ODI is measured 0 (minimal disability) to 100 (maximal disability).	baseline and 6 months
Secondary	Numeric Rating Scale change	Changes from baseline in Numeric Rating Scale (NRS) score at 6 months. Eleven-point pain scale used for patient self-reporting of pain, which ranges from 0 (no pain) to 10 (the worst pain imaginable).	baseline, and 6 months
Secondary	Neurological status change	Change from baseline in motor function (graded 0 - no movement to 4 - active movement against resistance), reflexes (0 - absence to 4 - abnormal/hyperactive) and sensory status (graded normal or abnormal) based on physician's physical exam at 1, 3, and 6 months.	baseline, 1, 3 and 6 months
Secondary	Magnetic Resonance Imaging (MRI) review to determine disc health changes	Magnetic Resonance Imaging (MRI) taken at baseline compared to 6 months reviewing changes in treated disc levels (disc height, volume hydration of disc and Modified Pfirrman grade)	baseline - 6 months
Secondary	Morphine Milligram Equivalents (MME) change	Changes from baseline in morphine milligram equivalents use at 3 and 6 months.	baseline, 1, 3 and 6 months
Secondary	PROMIS-29 change	Change from baseline in pain intensity at 3 and 6 months. Questionnaire with 29 questions using a since 0-10 numeric rating item and sevel health domains (physical function, pain interference, fatigue depressive symptoms, anxiety, ability to participate in activities and sleep) utilizing four questions per domain.	baseline, 3 and 6 months