The purpose of this study is to evaluate the safety and exploratory efficacy of KTP-001 in
subjects with lumbar disc herniation.
- Trial ID:
- Timothy Peppers
- Subject has had a single contained or noncontained (extruded) lumbar disc herniation (L3-L4, L4-L5 or L5-S1) diagnosed by clinical symptoms and/or physical findings and confirmed by MRI.
- Subject has leg pain with a documented positive straight leg raise (SLR) test or femoral stretch test (FST).
- Subject has experiences herniated disc symptoms for at least 6 weeks prior to the study without relief with pain medications and other therapies.
- Subject has a BMI of 18 to 35 kg/m2
- Subject has a sequestered lumbar disc herniation or intrathecal herniation confirmed by MRI
- Subject has two or more symptomatic lumbar disc herniations
- Previous intradiscal therapeutic intervention or has had any lumbar surgery
- Presence of lumbar spine disease and/or deformity other than a lumbar disc herniation
- Active smoker or is unable to abstain from tobacco use for 2 weeks prior to study injection
- Subject has a history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease