A Study to Evaluate Safety and Exploratory Efficacy of KTP-001 in Subjects With Lumbar Disc Herniation

• Status: Completed
• Trial end date: 2018-10-16
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and exploratory efficacy of KTP-001 in subjects with lumbar disc herniation.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Teijin America, Inc.

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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