A Clinical Study Evaluating the Safety and Effectiveness of VIA Disc NP in Subjects With Symptomatic Disc Degeneration (RESTORE)

Vivex Biomedical

Status: Enrolling

Conditions: Degenerative Disc Disease; Lumbar Discogenic Pain; Disc Degeneration

Treatments: Other: VIA Disc NP

Study type: Interventional

Funder types: Industry

Identifiers

NCT06778447

VIA-2024-002

Details and patient eligibility

About

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

This is a prospective, multi-center, single arm, open label study in which subjects with lumbar discogenic pain associated with intervertebral disc degeneration will receive 1 VIA-Disc NP treatment to each affected level (up to 2 levels).

Enrollment: 60 estimated patients

Sex: All

Ages: 22 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 22 to 85 years old
• Diagnosis of early to moderate degenerative disc disease (DDD), Modified Pfirrmann Grade 3-7
• Chronic axial midline low-back pain with or without referred non-radicular leg pain for at least 6 months prior to screening; unresponsive to at least 3 months of conservative care
• Low-back pain severity score of ≥ 40 to ≤ 90 mm on the VAS
• ODI score of ≥ 40 to ≤ 80
• Positive sustained hip flexion test as confirmed with the Neurologic Exam indicating positive provocation with sustained hip flexion at the time of screening
• Demonstrated intolerance to sitting for more than 30 minutes at a time based on self-report or assessed by a qualified healthcare professional at the screening visit
• Able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study
• 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
• Involvement of more than two lumbar discs
• 3 or more discs with a Modified Pfirrmann grade of 3 or greater
• Disc height of less than 4mm for any disc between L1-S1
• Fracture of the lumbar spine, previous lumbar spine surgery or previous surgical treatment of the target disc
• History of sacroiliac (SI) joint pain/injections during the past 1 month 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) or any nerve ablation procedures at the same or adjacent level (e.g., Basivertebral nerve ablation, dorsal ramus or sinuvertebral nerve ablations); discography and anesthetic discography may be performed but must be done at least 2 weeks or more prior to the VIA Disc NP procedure
• History of lumbar facet joint steroid injections within 4 weeks of procedure
• History of lumbar radiofrequency ablation within 8 weeks of procedure
• Received prior stem cell/progenitor cell therapy or other biological intervention (e.g., PRP) to repair the target intervertebral disc
• Evidence of dynamic instability on lumbar flexion-extension radiographs
• Grade 2 or higher spondylolisthesis at the target disc, lumbar spondylitis or other undifferentiated spondyloarthropathy, or Type III Modic changes around the target disc
• Clinical suspicion of a full thickness annular tear at the target disc or other abnormal disc morphology
• Clinical suspicion of facet pain as primary pain generator
• A systemic condition or disease not stabilized or judged by the Investigator to be incompatible with participation in the study (e.g. current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, history of myocardial infarction, uncontrolled diabetes (>7.0% HbA1C), etc.)
• Received VIA Disc NP previously.
• Deemed unsuitable for clinical study participation by the Investigator
• 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 and 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
• Opioid use of more than 90 MME/day
• 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)
• Metal or ceramic implants in the lumbar spine region
• Non-MRI compatible devices and active implantable devices such as spinal cord stimulators, intrathecal pumps, etc.
• Compensated injuries or ongoing litigation regarding back pain/injury, or financial or other incentives to remain impaired
• 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
• Diagnosis of any traumatic neurological disorders
• Women who are pregnant or breastfeeding at the time of enrollment and/or plan to become pregnant during the study; pregnancy is confirmed by:
• a positive pregnancy test during the screening visit
• self-reported pregnancy
• Women of childbearing potential (WOCBP) who are not using a reliable form of contraception (as determined by the Investigator)
• Received any experimental drug or device used within 30 days prior to the screening visit or during the course of the clinical trial.
• Other persistent pain/nerve issues including, for example, radiculopathy, leg pain, cauda equine syndrome, etc.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

VIA Disc NP

Experimental group

Description:

A single dose, intradiscal delivery of 100mg of VIA Disc NP mixed with sterile saline according to product Instructions for Use (IFU) and administered at up to two affected levels, L1-S1.

Treatment:

Other: VIA Disc NP