Source Healthcare is proud to announce its involvement in a pivotal Phase III clinical trial for VIVEX‘s investigational therapy, VIA Disc NP. This innovative treatment aims to provide lasting relief for patients suffering from chronic low back pain caused by degenerative disc disease, a condition that affects millions and limits daily functioning.
VIVEX - A Phase III Clinical Trial Using Donor Nucleus Pulposus Tissue for Degenerative Disc Disease
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Overview of the VIA Disc NP Clinical Trial
The VIA Disc NP Phase III clinical trial is a groundbreaking study that aims to evaluate the safety and effectiveness of an innovative regenerative therapy for chronic low back pain caused by degenerative disc disease. VIA Disc NP is processed from donated cadaveric nucleus pulposus tissue that is lyophilized and ground into particles that are ≤106 µm in size. These particles are aliquoted into a volume size of 100mg (+/- 10%), then reconstituted with saline in a fully closed mixing system. A single dose of 100 mg VIA Disc NP mixed with saline is injected into up to two affected disc level(s). This groundbreaking treatment aims to achieve a minimal clinically important difference in back pain scores in comparison to the sham procedure.
Participants in the trial will undergo a structured program, including an initial screening phase, a single treatment injection, and follow-up visits over 24 months. For participants randomized to the control procedure (sham), a cross-over option will be available at the 12-month point post-procedure. The study is a step in offering a minimally invasive alternative for patients who have not found relief through conventional therapies, providing hope for long-term pain management and improved quality of life.
Study Design and Visit Requirements
The VIVEX – Phase III clinical trial is a structured program that aims to assess the efficacy and safety of VIA Disc NP. Participants will engage in the study over 24 months, with a minimum of 6 visits to the research site. These visits are divided into three distinct phases: screening, treatment, and follow-up. Here’s what you can expect during each phase.
Screening Phase
Before beginning the trial, you will undergo a thorough screening to determine your eligibility. This includes a medical history review, diagnostic tests, and discussions with our clinical team about your health and pain history. The goal is to confirm that you meet all the criteria for participation, ensuring the trial is suitable for your condition and will deliver meaningful results.
Treatment Phase
Once enrolled, you will receive an injection of VIA Disc NP (the investigational treatment) or a placebo (sham injection) as part of the study’s control group. This single outpatient procedure is minimally invasive and administered directly into the affected spinal disc. The treatment targets inflammation and supports tissue repair to relieve pain.
Follow-Up Phase
After the injection, you will participate in regular follow-up visits over 24 months. These visits allow our team to monitor your progress, assess your response to the treatment, and ensure your overall health. You’ll undergo physical exams, pain assessments, and functional evaluations. This phase is critical for understanding the long-term benefits of the drug.
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Potential Benefits of Participation:
- Access to a state-of-the-art regenerative therapy that could alleviate chronic back pain.
- All treatments, assessments, and diagnostics are covered at no cost to you or your insurance.
- Participants will receive compensation for their time and travel associated with the study.
Cost and Compensation for Participation
Participating in the VIA Disc NP clinical trial comes at no cost to you. All treatments, diagnostic procedures, and assessments required for the study are fully covered by the trial sponsor. Additionally, you will receive compensation for your time and travel to each of the follow up visits over the 24-month study period. This ensures you can focus on your health and participation without financial burden.
You May Be Eligible to Participate in the Study if:
- You are 22-85 years of age
- You have experienced chronic low back pain for at least six months
- You have been diagnosed with degenerative disc disease
- You have not found relief from conservative treatments over the past six months
- You are not pregnant or planning to become pregnant during the 24-month study period
How to Enroll in the Vivex - A Phase III Clinical Trial
If you are interested in participating or would like more information about the Mesoblast Phase III Clinical Trial, we invite you to contact our research team.
Phone: Call 310-564-5820 ext. 3
