Clinical Trial Information

Wayne State University Physicians Group and the Department of Neurological Surgery are seeking volunteers for a clinical research study to evaluate the safety and effectiveness of the investigational drug SI-6603. The investigational drug (SI-6603) is an alternative to laminectomy, which is the current standard surgical treatment for lumbar (lower back) disc herniation in the United States.

• Patients between the ages of 30-70 with a diagnoses of mild to moderate lumbar disc herination and have not responded to non-operative conservative treatment may be candidates for the study.
  
  
• The investigational drug (SI-6603) is injected into the center of the herniated disc in the hopes of decreasing the size of the herniation and therefore minimizing and/or resolving the symptoms and possibly avoiding surgery; the patients will be followed for 52 weeks and will be evaluated by MRI and X-ray to determine if the herniation size has decreased.
  
  
• The study drug (SI-6603) is investigational which means that is has been approved by the Food and Drug Administration to be used in ths clinical trail.
  
  
• There will be no additional costs to the patient for participation in the study.
  
  
• Those that qualify will receive compensation for their time and expenses.
  
  

For further information please contact:
Dr.Hazem Eltahawy, M.D., Primary Investigator
Kelly Forcucci, R.N., Clinical Research Coordinator
(313) 966-8118
E-mail:kforcucc@med.wayne.edu