Study to Evaluate Safety of C-1101 Versus Sterile Saline in Adults With Chronic Painful Lumbosacral Radiculopathy
Trial Parameters
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of C-1101 administered as a single dose, transforaminal epidural injection compared to sterile saline
Eligibility Criteria
Inclusion Criteria: * Diagnosis of painful LSR (sciatica) radiating to or below the knee, with an inadequate response to conservative care * Body mass index \< 35 kg/m2. Exclusion Criteria: * Presence of clinically significant disease or any other painful condition that may interfere with assessments. * Any condition that currently requires blood or platelet transfusions. * Diagnosed with schizophrenia, bipolar disorder, or major depressive disorder. * Increased risk of bleeding or is taking anticoagulants or platelet aggregation inhibitors. * History or presence of autonomic neuropathy, diabetic neuropathy, or other peripheral neuropathies. * History of myocardial infarction within the last 6 months or congestive heart failure. * The presence of an active malignancy or tumor. * Have undergone a surgical procedure for back pain. * Recent use of immunosuppressants, oral steroids, or intravenous steroids.