Source Healthcare is excited to announce that we are currently recruiting for the Phase II clinical trial of BioRestorative’s investigational stem cell therapy, BRTX-100. This study targets individuals suffering from chronic low back pain associated with degenerative disc disease. It explores the potential of stem cell therapy to provide long-term relief for back pain sufferers by treating the underlying causes of disc degeneration rather than merely managing symptoms.
Overview of the BioRestorative Clinical Trial
The BioRestorative Phase II clinical trial investigates the effects of BRTX-100, an innovative, autologous stem cell therapy. Derived from the patient’s own cells, BRTX-100 involves using Mesenchymal Precursor Cells (MPCs) collected from the bone marrow and then processed in a laboratory. Through a single injection into the affected spinal disc, this therapy aims to reduce pain-related disability and improve the overall function of the degenerative disc.
This study represents a new approach to treating lumbar degenerative disc disease, one of the leading causes of chronic back pain. Traditional treatments like medications, steroid injections, and physical therapy focus primarily on symptom management. By injecting stem cells into the damaged disc, the hope is to stimulate the body’s natural healing process, offering patients a chance to experience true relief and potential disc regeneration.
Study Design and Visit Requirements
If you participate in this clinical trial, you’ll join approximately 100 other adults with degenerative disc disease over a period of about two years. You’ll have a two-in-three chance of receiving either the investigational product (BRTX-100) or a saline solution. If you’re selected for the active treatment, you’ll receive a single injection directly into your painful disc.
Over 24 months, you’ll make around seven visits to our site, where trained professionals will monitor your progress and collect valuable data on how BRTX-100 impacts degenerative disc disease. During the first six months, you’ll have more frequent check-ins to observe your response to the treatment. After this period, visits will be less frequent, focusing on tracking long-term effects and any improvements in pain relief.
SCHEDULE A
CONSULTATION
Potential Benefits of BRTX-100 for Chronic Back Pain
The clinical trial’s investigational drug, BRTX-100, offers an exciting alternative to conventional back pain treatments. Traditional pain treatments tend to focus on temporary pain relief, often leading patients toward invasive surgical interventions, which carry significant risks. BRTX-100, on the other hand, targets the root cause of disc degeneration, potentially alleviating pain while promoting damaged tissue repair and helping patients avoid surgery.
Cost and Compensation for Participation
Participation in the BioRestorative Phase II trial comes at no cost to the patient or their insurance. The study sponsor will cover all necessary diagnostic testing, including any imaging or blood work required for screening and follow-up visits. In addition, participants will receive compensation after completing each of the follow-up visits.
You May Be Eligible to Participate in the Study if:
- You are aged between 18 and 60 years old
- You have had lower back pain for at least six months
- You have been diagnosed with painful lumbar disc degeneration
- You have not found relief from medication, physical therapy, or injections
- You are not pregnant, breastfeeding, or planning to become pregnant during the study period
- You have not undergone lumbosacral spine surgery
- You have refrained from using nicotine products for at least three months
How to Enroll in the BioRestorative Trial
If you are experiencing chronic low back pain and meet the criteria listed above, you may be a candidate for this innovative study. Contact the clinical research office to schedule a screening appointment. A study doctor will review your medical and surgical history and conduct additional assessments to determine if this study suits you. They’ll also provide detailed information about the trial, answer any questions, and discuss the potential risks and benefits.
Taking part in this trial not only gives you access to cutting-edge care but also contributes to vital research that could revolutionize treatment options for degenerative disc disease.
