for people ages 30-70 (full criteria)
at Sacramento, California and other locations
study started
estimated completion



This study is to evaluate the effectiveness of a single-dose intervertebral disc injection of SI-6603 in subjects with lumbar disc herniation (LDH)

Official Title

A Multicenter, Randomized, Double-blind, Sham-controlled, Comparative Study of SI-6603 in Subjects With Lumbar Disc Herniation (Phase 3)


Lumbar Disc Herniation Radiculopathy Sciatica Intradiscal injection Chemonucleolysis Hernia


You can join if…

Open to people ages 30-70

  • Subjects with single-level LDH (L4-L5 or L5-S1 (or L5-L6)) with clear, demonstrable nerve root impingement as assessed by magnetic resonance imaging (MRI) and clinical symptoms corresponding to position of the impaired nerve root.
  • Subjects with radiculopathy/radicular leg pain in the unilateral leg for 6 weeks or more but 1 year or less.
  • Subjects with positive result of Straight Leg Raise (SLR) test (≤70°) only on the ipsilateral leg having chief complaint of radiculopathy
  • Subjects with inadequate improvement in pain caused by LDH despite 6 weeks or more of conservative treatment.

You CAN'T join if...

  • Subjects who have 2 or more lumbar disc herniations as assessed by MRI.
  • Subjects who have undergone a lumbar operation, lumbar percutaneous nucleotomy, or lumbar intradiscal therapies at the affected level of lumbar spine.
  • Subjects who have received block procedure (e.g., spinal injection, epidural injection or nerve block) for treatment of LDH, oral or injectable corticosteroids within 28 days prior to randomization.
  • Subjects who have received opioids or cannabis by any route of administration, local anesthesia to the back, buttock, or posterior/lateral aspects of the affected leg within 7 days prior to randomization.
  • Subjects with a body mass index (BMI) ≥40.
  • Subjects who are receiving compensation according to the Workers' Compensation Act or are involved in personal injury litigation due to a lumbar-related injury.


  • UC Davis Spine Center accepting new patients
    Sacramento California 95816 United States
  • Allied Clinical Research withdrawn
    Gold River California 95670 United States
  • Neurovations Research withdrawn
    Napa California 94558 United States


accepting new patients
Start Date
Completion Date
Seikagaku Corporation
Study website Sign up for this study
Phase 3
Study Type
Last Updated