VIA Disc NP for Degenerative Disc Disease
(RESTORE Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: VIVEX Biologics, Inc.
Must not be taking: Antidepressants, Antipsychotics, Long-acting opioids
Disqualifiers: Lumbar surgery, Uncontrolled diabetes, Substance abuse, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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).
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are using prescribed extended-release narcotics, you may need to wean off them before enrolling. Short-acting opiates may be allowed, but their use will be monitored after treatment.
Is VIA Disc NP safe for humans?
The safety data from a clinical trial on a similar treatment, NOVOCART Disk plus, showed that it was generally safe with no significant immune reactions or harmful effects observed. The rate of adverse events was similar to what is expected after elective disk surgery, indicating a relatively low risk.
12345How is the VIA Disc NP treatment different from other treatments for degenerative disc disease?
VIA Disc NP is unique because it focuses on the biological regrowth of the nucleus pulposus (the soft center of the disc), which is different from traditional treatments like fusion surgery that aim to stabilize the spine. This approach may help restore the disc's natural function and reduce stress on adjacent discs, potentially preventing further degeneration.
36789Eligibility Criteria
This trial is for adults aged 22-85 with early to moderate degenerative disc disease causing chronic low-back pain, unresponsive to at least 3 months of conservative care. Participants must have specific levels of pain and disability, be intolerant to sitting for over 30 minutes, and commit to the study's duration with a life expectancy over 2 years.Inclusion Criteria
I have had chronic lower back pain for over 6 months, not relieved by 3 months of standard treatment.
I am between 22 and 85 years old.
ODI score of ≥ 40 to ≤ 80
+6 more
Exclusion Criteria
Evidence of dynamic instability on lumbar flexion-extension radiographs
Non-MRI compatible devices and active implantable devices such as spinal cord stimulators, intrathecal pumps, etc.
Received VIA Disc NP previously
+27 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive a single dose, intradiscal delivery of 100mg of VIA Disc NP to each affected level
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
24 months
Multiple visits over 24 months
Participant Groups
VIA Disc NP is being tested as a non-surgical treatment for lumbar discogenic pain due to intervertebral disc degeneration. This single-arm study involves one treatment per affected level (up to two) in subjects who meet the criteria.
1Treatment groups
Experimental Treatment
Group I: VIA Disc NPExperimental Treatment1 Intervention
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Premier Spine and Pain InstituteThornton, CO
Spine Institute of LouisianaShreveport, LA
Loading ...
Who Is Running the Clinical Trial?
VIVEX Biologics, Inc.Lead Sponsor
References
Screening for nuclear replacement candidates in patients with lumbar degenerative disc disease. [2020]Nuclear replacement is an emerging surgical treatment for degenerative disc disease (DDD) and low back pain (LBP). While clinical experience is most extensive with the prosthetic disc nucleus PDN (Raymedica, Minneapolis, Minnesota), strict indications apply for the implantation of this device. The purpose of this study was to ascertain what percentage of patients treated surgically for degenerative disc disease with other surgical procedures would have been candidates for nuclear replacement implantation.
Novel stepwise model of intervertebral disc degeneration with intact annulus fibrosus to test regeneration strategies. [2019]Novel preclinical models that do not damage the annulus fibrosus (AF) of the intervertebral disc are required to study the efficacy of new regenerative strategies for the nucleus pulposus (NP). The aim of the study was to characterize a preclinical ovine model of intervertebral disc degeneration (IDD) induced by endplate (EP) damage and repair via the transpedicular approach, with or without partial nucleotomy, while keeping the AF intact. Twelve adult sheep were used. By the transpedicular approach, a 2 mm tunnel was drilled to the NP through the EP. A partial-nucleotomy was performed. The tunnel was sealed using a polyurethane scaffold. Lumbar discs were assigned to different groups: L1-2: nucleotomy; L2-3: EP tunnel; L3-4: nucleotomy + EP repair; L4-5: EP tunnel + repair; L5-6: control. X-Ray and MRI were performed at 0, 1, 3, and 6 months after surgery. Disc height and MRI indexes were calculated. Macro- and micro-morphology were analyzed. Pfirrmann and Thompson grades were assigned. The treated discs exhibited a progressive decrease in NP signal intensity and MRI index, displaying specific grades of degeneration based on the surgical treatment. According to Pfirrmann and Thompson grades different procedures were staged as: EP tunnel + repair: grade-II; EP tunnel: grade-III, nucleotomy + EP repair: grade-IV; nucleotomy: grade-V. A new stepwise model of IDD to study and test safety and efficacy of novel strategies for NP regeneration has been characterized. The different degrees of IDD have been observed similar to Pfirrmann and Thompson grading system. The intact AF allows for loading studies and eliminating the need for AF closure. © 2018 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 36:2460-2468, 2018.
The biomechanics of a multilevel lumbar spine hybrid using nucleus replacement in conjunction with fusion. [2013]Degenerative disc disease is commonly a multilevel pathology with varying deterioration severity. The use of fusion on multiple levels can significantly affect functionality and has been linked to persistent adjacent disc degeneration. A hybrid approach of fusion and nucleus replacement (NR) has been suggested as a solution for mildly degenerated yet painful levels adjacent to fusion.
A prospective randomized multicenter phase I/II clinical trial to evaluate safety and efficacy of NOVOCART disk plus autologous disk chondrocyte transplantation in the treatment of nucleotomized and degenerative lumbar disks to avoid secondary disease: safety results of Phase I-a short report. [2022]NOVOCART® Disk plus, an autologous cell compound for autologous disk chondrocyte transplantation, was developed to reduce the degenerative sequel after lumbar disk surgery or to prophylactically avoid degeneration in adjacent disks, if present. The NDisc trial is an ongoing multi-center, randomized study with a sequential phase I study within the combined phase I/II trial with close monitoring of tolerability and safety. Twenty-four adult patients were randomized and treated with the investigational medicinal product NDisc plus or the carrier material only. Rates of adverse events in Phase I of this trial were comparable with those expected in the early time course after elective disk surgery. There was one reherniation 7 months after transplantation, which corresponds to an expected reherniation rate. Immunological markers like CRP and IL-6 were not significantly elevated and there were no imaging abnormalities. No indications of harmful material extrusion or immunological consequences due to the investigational medicinal product NDplus were observed. Therefore, the study appears to be safe and feasible. Safety analyses of Phase I of this trial indicate a relatively low risk considering the benefits that patients with debilitating degenerative disk disease may gain.
Mechanical testing of a novel hydrogel nucleus replacement implant. [2022]Both total disc and nucleus replacement arthroplastic approaches are emerging as viable treatment modalities for discogenic pain resulting from degenerative disc disease. The results of the testing in this investigation show that this novel nucleus replacement implant exhibits physical and mechanical properties which make it uniquely suitable as a replacement to the degenerated nucleus pulposus.
Disc degeneration reduces the delamination strength of the annulus fibrosus in the rabbit annular disc puncture model. [2021]Degenerative disc disease is a common pathologic disorder accompanied by both structural and biochemical changes. Changes in stress distribution across the disc can lead to annulus fibrosus (AF) damage that can affect the strength and integrity of the disc. Given that some present degeneration therapies incorporate biological regrowth of the nucleus pulposus (NP), it is crucial that the AF remains capable of containing this newly grown material.
Plain film evaluation of degenerative disk disease at the lumbosacral junction. [2022]Diagnosing degenerative disk disease (DDD) at the lumbosacral junction (LSJ) on plain films is often difficult, compared with other disk levels. The purpose of this study was to determine whether criteria for diagnosis of DDD at the LSJ can be established for plain films.
Fusion surgery for lumbar degenerative disc disease: still more questions than answers. [2022]Yoshihara H, Yoneoka D. National trends in the surgical treatment for lumbar degenerative disc disease: United States, 2000 to 2009. Spine J 2015;15:265-71 (in this issue).
[Dynamic neutralization using the Dynesys system for treatment of degenerative disc disease of the lumbar spine]. [2016]Degenerative disc disease (DDD) is a spinal condition resulting from degeneration of the intervertebral discs. It is associated with symptoms of sciatica, back pain and leg weakness and also with degenerative instability of the spine. To arrest the degenerative cascade of disc disease, and taking into consideration stress placed on the adjacent discs managed by decompression and stabilisation by instrumented fusion, the lumbar spine was treated by dynamic posterior stabilisation of the segments affected. Based on the classification described by Dubois et al., the Dynesys system was used. The aim of this study was to evaluate the mid-term results of this method in DDD patients.