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Tests treatment safety and results for Degenerative Disc Disease
Official title Clinical Trial Evaluating the Safety and Efficacy of Nucleus Pulposus Allograft in Participants With Degenerative Disc Disease
ClinicalTrials.gov ID: NCT06778447
What this study is testing
- What it's testing
- VIA Disc NP is a non-surgical intervention intended to supplement nucleus pulposus tissue in degenerated intervertebral discs. This is a randomized, sham-controlled, multi-center, double-blind clinical trial with an open label roll-in period of one participant per site in which participants with lumbar discogenic pain associated with DDD will receive one VIA Disc NP treatment to each affected level (up to 2 levels).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 85
You may be able to join if
- Age 22 to 85 years old
- Diagnosis of moderate to severe DDD on MRI, Modified Pfirrmann Grade 3-7
- Chronic axial midline low-back pain in the absence of lower extremity motor/sensory/reflex changes with or without referred non-radicular leg pain...
- Low-back pain severity score of ≥ 40 to ≤ 90 mm on the VAS
- ODI score of ≥ 40 to ≤ 80
You likely can't join if
- Contraindications to the proposed sedation/anesthetic protocol
- Involvement of more than two lumbar discs as evidenced by 3 or more discs with Modified Pfirrmann grade of 3 or greater
- Disc height of less than 4mm for any disc between L1-S1
- Symptomatic vertebral compression fracture
- Previous surgical treatment of the lumbar spine
- History of sacroiliac (SI) joint fusion within the past six months
See the full eligibility criteria
Who can join
- Age 22 to 85 years old
- Diagnosis of moderate to severe DDD on MRI, Modified Pfirrmann Grade 3-7
- Chronic axial midline low-back pain in the absence of lower extremity motor/sensory/reflex changes with or without referred non-radicular leg pain for at least 6 months prior to screening; unresponsive to at least 3...
- Low-back pain severity score of ≥ 40 to ≤ 90 mm on the VAS
- ODI score of ≥ 40 to ≤ 80
- Positive sustained hip flexion test
- Demonstrated intolerance to sitting
- 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
What rules you out
- Contraindications to the proposed sedation/anesthetic protocol
- Involvement of more than two lumbar discs as evidenced by 3 or more discs with Modified Pfirrmann grade of 3 or greater
- Disc height of less than 4mm for any disc between L1-S1
- Symptomatic vertebral compression fracture
- Previous surgical treatment of the lumbar spine
- History of sacroiliac (SI) joint fusion within the past six months
- Received lumbar epidural or intradiscal steroid injection, lumbar facet joint steroid injection, lumbar radiofrequency ablation, provocative or anesthetic discography, SI joint pain injection, injection of methylene...
- Received intraosseous radiofrequency nerve ablation procedure at the same or adjacent level (e.g., Basivertebral nerve ablation or sinuvertebral nerve ablations)
- Received prior intradiscal stem cell/progenitor cell therapy or other biological intervention (e.g., MSC, PRP) at the target level within 12 months of the Day 0 procedure
- Evidence of dynamic instability on lumbar flexion-extension radiographs (\>3 mm)
- Grade 2 or higher spondylolisthesis at the target level, lumbar spondylitis or other undifferentiated spondyloarthropathy, or Type III Modic changes adjacent to the target disc
- Radiographic evidence 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...
- Received VIA Disc NP previously.
- Deemed unsuitable for clinical study participation by the Investigator
- Evidence of substance abuse (including marijuana); note: people using prescribed extended-release narcotics (e.g., fentanyl patch, MS Contin, oxycontin) within the 3 months prior to screening and people on long-acting...
- 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, or inhalation steroids for asthma is allowed)
- Metal or ceramic implants in the lumbar spine region
- Contraindications to MRI, including non-MRI compatible devices and active implantable devices such as spinal cord stimulators, intrathecal pumps, etc.
- Involved in ongoing or closed (within 6 months of screening visit) litigation related to their back pain condition
- Any mental instability, unstable bipolar disorders, unmanaged post-traumatic stress disorder (PTSD) or uncontrolled anxiety/depression and/or require new or changed anti-depressants or anti-psychotic medications within...
- Diagnosis of any traumatic neurological disorders that may impact the study as per the judgement of the Investigator
- 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 to treat the same condition used within 6 months 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.
The study team makes the final eligibility decision.
Where it's taking place
- Napa, California, United States
- Santa Monica, California, United States
- Thornton, Colorado, United States
- Gainesville, Florida, United States
- Woodstock, Georgia, United States
- New Castle, Indiana, United States
- Kansas City, Kansas, United States
- Lexington, Kentucky, United States
- New Orleans, Louisiana, United States
- Shreveport, Louisiana, United States
- Slidell, Louisiana, United States
- Reno, Nevada, United States
- Shrewsbury, New Jersey, United States
- New York, New York, United States
- New Bern, North Carolina, United States
- Eugene, Oregon, United States
- Shenandoah, Texas, United States
- Tyler, Texas, United States
- Charleston, West Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Napa, California, United States; Santa Monica, California, United States; Thornton, Colorado, United States; Gainesville, Florida, United States; Woodstock, Georgia, United States; New Castle, Indiana, United States and 13 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.