Platelet Lysate vs Saline for Lumbosacral Radiculopathy

Eligibility 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 2 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. Have significant leg pain, numbness, or tingling that causes the patient to alter or change activities.
• 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
• 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.