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

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