New Orleans, LANCT06778447Now EnrollingIRB Ready

Degenerative Disc Disease Clinical Trial in New Orleans, LA

Access cutting-edge degenerative disc disease treatment through this clinical trial at a research site in New Orleans. Study-provided care at no cost to qualified participants.

Sponsored by VIVEX Biologics, Inc.

Quick Self-Assessment

See if you qualify for this New Orleans location

Preparing your pre-screening questions…

Expert Care in New Orleans

Access degenerative disc disease specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related degenerative disc disease treatment provided free

Apply for This New Orleans Location

Check if you qualify for this degenerative disc disease clinical trial in New Orleans, LA

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to New Orleans

    Convenient for LA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit New Orleans site if eligible
  4. 4Begin participation

About This Degenerative Disc Disease Study in New Orleans

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). Participants enrolled after the roll-in stage will be randomized on a 2:1 basis to receive either a single VIA Disc NP intradiscal injection at 1 or 2 levels or the sham procedure at 1 or 2 levels. At 12 months, participants in the sham arm with continued symptoms may cross-over, receive VIA Disc NP, and will restart the study visit schedule, completing an additional 12 months of follow-up post-cross-over.

Sponsor: VIVEX Biologics, Inc.

Who Can Participate

Inclusion Criteria

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 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
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

Exclusion Criteria

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 blue, dextrose, glucosamine, and chondroitin sulfate, or biacuplasty within 3 months of the Day 0 procedure
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 immunodeficiency disease, recent 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, 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 3 months of enrollment
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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in New Orleans?

Yes, this clinical trial (NCT06778447) has an active research site in New Orleans, LA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Degenerative Disc Disease Treatment Options in New Orleans, LA

If you're searching for degenerative disc disease treatment options in New Orleans, LA, this clinical trial (NCT06778447) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our New Orleans research site is actively enrolling participants for this clinical trial. You'll receive care from experienced degenerative disc disease specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all degenerative disc disease clinical trials near you to find additional studies recruiting in your area.

More Rheumatoid Arthritis Trials in New Orleans, LA

See all rheumatoid arthritis clinical trials recruiting in New Orleans — not just this study.

Browse Rheumatoid Arthritis Trials in New Orleans →

Browse More Trials by Condition

Rheumatoid Arthritis TrialsAnkylosing Spondylitis TrialsAll Conditions →

Ready to Join in New Orleans?

Take the first step toward participating in this groundbreaking clinical trial

Secure · Expert Care · New Orleans, LA