What is the CASCADE Study?
The CASCADE Study is a Phase III clinical research study investigating whether a potential new treatment is safe and effective for treating low back pain associated with degenerative changes of a spinal disc. The investigational product is a type of adult stem cell therapy that will be given alone or mixed with a carrier material (hyaluronic acid), and will be compared with placebo (which does not contain any active medication).
The study will recruit from study centers in the United States and Australia, and the study will last about 3 years.
What is the investigational product?
The investigational product is given as an injection into the center of the damaged spinal disc that is causing back pain. The investigational product has been developed from a type of adult stem cell that has been taken from bone marrow samples of healthy human donors and grown in a laboratory.
Eligible patients will be randomly assigned (like flipping a coin) to one of three groups: stem cells alone, stem cells mixed with a carrier material, or saline placebo (which looks like the investigational product but contains no active ingredient). There is a 2 in 3 chance of being assigned to one of the two groups that will receive the stem cells.
Why is the CASCADE Study important?
Current therapies treat the pain associated with degenerative changes of a spinal disc rather than targeting the cause of the pain. This means that the disc continues to degenerate until the pain can no longer be managed and activities are impaired. In severe disease, surgical intervention is sometimes considered as this is currently the only means to have stopped the progression of degenerative changes of a spinal disc.
The information from this study may help to advance our knowledge of the investigational product, and may benefit other people with degenerative changes of a spinal disc in the future.
You may be eligible to participate in the CASCADE Study if you:
- are 18 years of age or older
- have degenerative changes of a disc
- have had low back pain for at least 6 months
- have received unsuccessful treatment for your back pain for at least 6 months.
Click here to answer a few simple questions to find out whether you may be eligible to participate in the CASCADE Study.
Thank you for your interest in the CASCADE Study.