Platelet Lysate vs Saline for Lumbosacral Radiculopathy

Launched by REGENEXX, LLC · Apr 4, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating two different treatments for a painful condition known as lumbosacral radiculopathy, often referred to as sciatica. Specifically, the trial will compare the effects of an injection made from platelet lysate, a substance derived from your own blood that may help healing, against a saline solution, which is a simple saltwater solution. Both treatments will be given through an injection in the lower back to see which one helps reduce pain and improve function better.

To be eligible for this trial, participants need to be between 18 and 65 years old and must have moderate to severe pain that radiates down the leg, along with imaging (like an MRI) confirming the source of the problem. They should also have tried other treatments, like medications or physical therapy, without sufficient relief. Participants can expect to receive one of the two treatments and will have follow-up visits to assess their pain and overall condition. It’s important to note that certain conditions, such as bleeding disorders or recent surgeries for back pain, would exclude someone from participating to ensure safety during the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Must be 18-65 years of age, inclusive, at time of signing informed consent
• • 2. At least moderate pain at screening using Patient Global Impression of Severity (PGIS)
• • 3. Diagnosis of lumbosacral radiculopathy (LSR) radiating to or below the knee in a single dermatomal pattern (L4, L5, or S1) with onset of clinical symptoms less than 1 year prior to screening visit
• • 4. Presence of one of the following: a radicular pattern (L4, L5, or S1) of sensory, reflex or strength changes
• • 5. Presence of persistent unilateral radicular pain. For participants with both leg and back pain, the leg pain must be worse than the back pain.
• • 6. LSR pain with inadequate response to conservative care (non-operative); participants must have tried at least one anti-inflammatory or analgesic medication (for at least 2 weeks at adequate doses) and at least one of the following: Physical therapy, bed rest, chiropractic manipulations, home directed lumbar and/or exercise programs.
• • 7. Lumbar spine MRI images are available after the onset of clinical symptoms and correlate with localization of clinical symptoms. CT is acceptable for patients with contraindication for MRI.
• • 8. Is independent, ambulatory, and can comply with post-treatment evaluations and visits.
• • 9. Voluntary signature of the IRB approved Informed Consent
• Exclusion Criteria:
• • 1. Untreated underlying psychological conditions (e.g. depression, chronic pain syndrome, etc.) as a contributor of pain
• • 2. Bleeding disorders
• • 3. Currently taking anticoagulant or immunosuppressive medication
• • 4. Evidence on MRI or CT of recent vertebral fracture or segmental instability (spondylolisthesis)
• • 5. Inflammatory or auto-immune based pathology (e.g. rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, polymyalgia, polymyositis, gout, pseudogout, etc.)
• • 6. Co-existing hip or knee pain localized to the joint structures that may interfere with the participant's ability to participate in the study or interfere with pain assessments
• • 7. Any central canal stenosis with neurogenic claudication (not including foraminal stenosis) with pain present mostly during walking and signs of lumbar stenosis on lumbar spine MRI/CT
• • 8. Has undergone a surgical procedure for back pain (e.g. discectomy, artificial disc replacement, fusion, etc)
• • 9. Presence of spinal cord stimulator
• • 10. Received epidural steroid injection or nerve blocks within the last 2 months
• • 11. Use of chronic opioids
• • 12. Documented history of drug abuse within the last 6 months
• • 13. Use of immunosuppressants, oral or intravenous steroids in the last 3 months
• • 14. Is pregnant
• • 15. Allergy or intolerance to study medication (e.g. lidocaine, etc.)
• • 16. Condition represents a worker's comp case and/or is involved in health-related litigation
• • 17. Presence of clinically significant disease that may interfere with the evaluation of safety and other clinical outcomes in the study
• • 18. Any other condition, that in the opinion of the investigator, would preclude the patient from enrollment.