A Phase I/II Multi-Center, Placebo-Controlled, Double-Blind, Randomized, Single Administration Clinical Trial to Evaluate the Safety, Tolerability, and Preliminary Effectiveness of Intradiscal rhGDF-5 for the Treatment of Early Stage Lumbar Disc Degeneration

The purpose of this study is to test the safety and performance of Indradiscal rhGDF-5 as an injectable treatment for degenerative disc disease in the lumbar spine (Low back).

You may be eligible to participate in this study if you:

• Must be at least 18 years of age
• Have persistent low back pain for at least 3 months with at least 3 months of non-surgical treatment
• Have 1 level of disc degeneration confirmed by discogram

You will be excluded from this study if you:

• Are unable to have an MRI, CT, or Discogram
• Have leg pain
• Have had any prior low back surgeries
• Have any instability/spondylolisthesis
• Are on long term steroid therapy for any reason (over 6 months)
• Have any form of cancer or diabetes
• Are involved in any litigation regarding the back pain or have a workmen’s compensation claim filed regarding the back
• Are involved in any other drug or device clinical study

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via e-mail, please include the title of the study in your message.