Clinical trial NCT05412277: VIA Disc Nucleus Pulposus Older Patients Pilot
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Degenerative Disc Disease
Low Back Pain
Disc Degeneration
Keywords: low back pain
degenerative disc disease
Lead sponsor: VIVEX Biologics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-06-09
Enrollment: 21
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Up to 35 patients at up to 15 sites will receive treatment.
Primary purpose: TREATMENT

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

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)

Primary outcomes:
measure: Patient self-reporting of Functional Efficacy with no change in neurological status using the Oswestry Disability Index (ODI)
timeFrame: baseline to 3 months
measure: Review of all Adverse Events for Safety of treatment and product
timeFrame: baseline to 6 months
measure: Patient self-reporting of Pain
timeFrame: baseline and 3 months
Secondary outcomes:
measure: Patient self-reporting of Function
timeFrame: 3-6 months
measure: Patient self-reporting of Pain
timeFrame: 3-6 months
measure: Patient self-reporting of Pain in low back
timeFrame: 3-6 months
measure: Oswestry Disability Index (ODI) score change
timeFrame: baseline and 6 months
measure: Numeric Rating Scale change
timeFrame: baseline, and 6 months
measure: Neurological status change
timeFrame: baseline, 1, 3 and 6 months
measure: Magnetic Resonance Imaging (MRI) review to determine disc health changes
timeFrame: baseline - 6 months
measure: Morphine Milligram Equivalents (MME) change
timeFrame: baseline, 1, 3 and 6 months
measure: PROMIS-29 change
timeFrame: baseline, 3 and 6 months
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Florida Spine & Pain Specialists
state: Florida
city: Newnan
country: United States
facility: Southern Pain and Spine Associates
state: Georgia
city: Slidell
country: United States
facility: Paradigm Spine Care & Interventional Pain
state: Louisiana
city: Winston-Salem
country: United States
facility: Center for Clinical Research
state: North Carolina
city: Tyler
country: United States
facility: Precision Spine Care
state: Texas
Study officials:
affiliation: Florida Spine & Pain Specialists
name: Nomen Azeem, MD
role: PRINCIPAL_INVESTIGATOR
References: