Status:
COMPLETED
STA363 in the Treatment of Lumbar Disc Herniation
Lead Sponsor:
Stayble Therapeutics
Collaborating Sponsors:
Cromsource
Antaros Medical
Conditions:
Lumbar Disc Herniation
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
The goal of this clinical trial is to establish safety and tolerability of STA363 injected into a herniated intervertebral disc in patients with sciatica due to disc herniation. The main questions the...
Detailed Description
The study will include 24 patients, recruited at 4 different sites, suffering from radiculopathy due to lumbar disc herniation (LDH). Patients will be screened for symptoms, disease history and magnet...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Signed informed consent prior to any study-related procedures
- Patient has a single subligamentous posteriolateral lumbar disc herniation (protrusion or extrusion) of any lumbar disc below L1/L2 diagnosed by clinical symptoms and/or physical findings and confirmed by MRI
- Patient has symptoms and/or physical findings consistent with a unilateral radiculopathy affecting one nerve root (L2-L5)
- Patient has leg pain of the dermatome consistent with the nerve root affected by the herniation
- The herniated disc is 3 or lower on the Pfirrmann scale (grade 1-5)
- Patient has experienced symptoms of a herniated disc for at least 6 weeks prior to randomisation without sufficient relief with pain medications and other conservative therapies
- Ability to understand the written and verbal information about the study
- Male and female patients 18 years or older but 50 years or younger
- Women of childbearing potential eligible if using effective contraceptives
- Patient has a body mass index (BMI) of ≥18 to ≤35 kg/m2
- Patients who meet all the following NRS selection criteria for radicular leg pain:
- Presence of at least 5 pain NRS assessments (entries) for 7 consecutive days
- NRS daily pain scores between 3-9
- Not more than 2 NRS scores of "3"
- Exclusion criteria:
- Treatment with any investigational product within 3 months prior to the screening visit
- Patient has a sequestered lumbar disc herniation or transligamentous/ herniation confirmed by MRI
- Patient has a bulging disc
- Patient has experienced symptoms of lumbar disc herniation for more than 6 months
- Patient has 2 or more symptomatic lumbar disc herniations (presence of non-symptomatic herniations in addition to the symptomatic herniation is allowed)
- Patient has cauda equina syndrome
- Previous intradiscal therapeutic intervention of the index disc or has had any lumbar spine surgery
- Presence of lumbar spine disease and/or clinically significant deformity other than a lumbar disc herniation which, in the opinion of the investigator, will affect evaluation of safety and/or efficacy
- Untreated, ongoing active infection and/or discitis
- Current infection or prior history of spinal infection (e.g., discitis, septic arthritis, epidural abscess) or an active systemic infection.
- Evidence of prior lumbar vertebral body fracture or trauma.
- Spondylolisthesis or retrolisthesis grade 2 and above or spondylolysis at the index or adjacent level(s).
- Lumbar spondylitis or other undifferentiated spondyloarthropathy affecting the index disc.
- Patients previously included in the study.
- Patients suffering from psychosomatic pain in the opinion of the Investigator.
- Patients requiring continuous treatment with warfarin or other anticoagulant therapy.
- Known alcohol and/or drug abuse.
- Pregnant or lactating females, or intention to become pregnant within the study period.
- Known allergy or intolerance to the contrast agent Omnipaque®.
- Known opioid allergy or intolerance.
- Any other condition that, in the opinion of the Investigator, precludes the patient from taking part in this study.
- Any specific contraindication for MRI such as claustrophobia, intracranial clips or pacemakers.
Exclusion
Key Trial Info
Start Date :
July 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2024
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06022263
Start Date
July 25 2023
End Date
September 1 2024
Last Update
December 10 2025
Active Locations (1)
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1
Samodzielny Publiczny Szpital Kliniczny nr 4, Klinika Ortopedii i Rehabilitacji
Lublin, Lublin Voivodeship, Poland, 20-002