Low Back Pain Due to Degenerative Disc Disease (DDD)
A Phase 1, First-in Human, Randomized, Double-Blind, Vehicle and Placebo Controlled Study in Subjects with Single Level, Symptomatic Lumbar Intervertebral Disc Degeneration
Do you suffer from Chronic Low Back Pain?
A research study may be an option for you. Why are we doing this research? The purpose of this research is to study a new investigational cell-based treatment for degenerative disc disease (DDD), which is a common cause of low back pain. DDD is a chronic and progressive disease that is characterized by inflammation and tissue breakdown of the intervertebral disc, which is located between the vertebral bones in the spine.
- Be between the ages of 18 and 75 years of age
- Have been experiencing chronic low-back pain for at least 6 months
- Have had low back pain that is unresponsive to at least 3 months of conservative (non-operative) care
Have a disc that is degenerating
(other qualification parameters apply)
Frequently Asked Questions
What will happen in the study?
You, as a participant will be given a consent form that thoroughly explains all of the details of the study.
What is involved:
- Screening procedures will be done to determine if you are eligible to participate in the study. This period can take up to 30 days in duration, however all screening tests and procedures will be completed in one visit.
- A one-time injection of the study drug into the painful disc
- Your participation in the study will include a total of 8 study visits, over approximately 2 years
Will being in the study help me?
This study is being done to see if the investigational product is safe and effective in reducing low back pain. The investigational product may help your DDD, but there is no guarantee that being in this study will help you. Information from this study might help researchers to come up with new tests or treatments to help others in the future.
Physicians’ Research Options (PRO) is an experienced Clinical Research Company dedicated to the performance of Phase II, III and IV Pharmaceutical and Pilot/Pivotal Medical Device clinical trials. Our staff experience totals over 60 years in Clinical / Medical Research.
Our staff recruits for and manages studies in Utah, Nevada, and Colorado.