STA363 in the Treatment of Lumbar Disc Herniation

Inclusion Criteria:

1. Signed informed consent prior to any study-related procedures
2. Patient has a single subligamentous posteriolateral lumbar disc herniation (protrusionor extrusion) of any lumbar disc below L1/L2 diagnosed by clinical symptoms and/orphysical findings and confirmed by MRI
3. Patient has symptoms and/or physical findings consistent with a unilateralradiculopathy affecting one nerve root (L2-L5)
4. Patient has leg pain of the dermatome consistent with the nerve root affected by theherniation
5. The herniated disc is 3 or lower on the Pfirrmann scale (grade 1-5)
6. Patient has experienced symptoms of a herniated disc for at least 6 weeks prior torandomisation without sufficient relief with pain medications and other conservativetherapies
7. Ability to understand the written and verbal information about the study
8. Male and female patients 18 years or older but 50 years or younger
9. Women of childbearing potential eligible if using effective contraceptives
10. Patient has a body mass index (BMI) of ≥18 to ≤35 kg/m2
11. Patients who meet all the following NRS selection criteria for radicular leg pain:
12. Presence of at least 5 pain NRS assessments (entries) for 7 consecutive days
13. NRS daily pain scores between 3-9
14. Not more than 2 NRS scores of "3"

Exclusion criteria:

1. Treatment with any investigational product within 3 months prior to the screeningvisit
2. Patient has a sequestered lumbar disc herniation or transligamentous/ herniationconfirmed by MRI
3. Patient has a bulging disc
4. Patient has experienced symptoms of lumbar disc herniation for more than 6 months
5. Patient has 2 or more symptomatic lumbar disc herniations (presence of non-symptomaticherniations in addition to the symptomatic herniation is allowed)
6. Patient has cauda equina syndrome
7. Previous intradiscal therapeutic intervention of the index disc or has had any lumbarspine surgery
8. Presence of lumbar spine disease and/or clinically significant deformity other than alumbar disc herniation which, in the opinion of the investigator, will affectevaluation of safety and/or efficacy
9. Untreated, ongoing active infection and/or discitis
10. Current infection or prior history of spinal infection (e.g., discitis, septicarthritis, epidural abscess) or an active systemic infection.
11. Evidence of prior lumbar vertebral body fracture or trauma.
12. Spondylolisthesis or retrolisthesis grade 2 and above or spondylolysis at the index oradjacent level(s).
13. Lumbar spondylitis or other undifferentiated spondyloarthropathy affecting the indexdisc.
14. Patients previously included in the study.
15. Patients suffering from psychosomatic pain in the opinion of the Investigator.
16. Patients requiring continuous treatment with warfarin or other anticoagulant therapy.
17. Known alcohol and/or drug abuse.
18. Pregnant or lactating females, or intention to become pregnant within the studyperiod.
19. Known allergy or intolerance to the contrast agent Omnipaque®.
20. Known opioid allergy or intolerance.
21. Any other condition that, in the opinion of the Investigator, precludes the patientfrom taking part in this study.
22. Any specific contraindication for MRI such as claustrophobia, intracranial clips orpacemakers.