What is a clinical research study?
A clinical research study is a medical study designed to answer questions about the safety and effectiveness of potential new treatments. Without clinical research studies, no new medications would be developed and few medical advances would be made. Choosing to take part in a clinical research study is an important personal decision for you and your family.
This brochure contains information that may help you decide whether you would like to take part in a clinical research study looking at a possible new treatment for degenerative disc disease. You may find it helpful to speak with your family doctor or pain specialist (if you have one) about the study.
What is degenerative disc disease?
Degenerative disc disease is a painful condition of the spine caused by damage to the discs that lie between the bones of the spine. The condition may occur as a result of normal aging or trauma. In degenerative disc disease, small tears or cracks appear in the strong outer layer of the disc, allowing the fluid inside the disc to leak out. This makes the disc thinner, or it may cause the disc to bulge or break open, leading to pain. Although degenerative disc disease can affect any part of the spine, it most often occurs in the lower back (lumbar region) or neck (cervical region).
Current treatments for degenerative disc disease include painkillers, physical therapy, exercises to strengthen and stretch the back, and alternative treatments such as chiropractic therapy and acupuncture. Doctors may prescribe strong painkillers called opioids or other types of medication. For some patients, injections (such as epidural steroid injections) and surgery may be recommended.
What is the CASCADE Study?
The CASCADE Study is looking at a potential new treatment (an investigational product) for people with degenerative disc disease. The investigational product is made from a certain type of adult stem cell. Stem cells are immature cells produced by the human body that have the ability to develop into many different types of cells.
The stem cells being looked at in this study are called mesenchymal precursor cells. The cells being used in the study have been carefully collected from bone marrow samples from healthy human adult donors and grown in a laboratory under strict conditions.
The CASCADE Study will involve approximately 330 adults with degenerative disc disease. The main study will last about 1 year; however, study participants will be asked to be followed up for a total of 3 years.
Everyone who takes part in the study will receive a single injection into their painful disc of either:
- the investigational product
- the investigational product combined with a carrier material called hyaluronic acid, or
- a saline solution, which looks like the investigational medication but contains no active ingredient.
There is a two in three chance of receiving the investigational product and a one in three chance of receiving a saline solution. The injections will be assigned randomly (like flipping a coin) and neither the study participant nor study doctors performing the follow-up assessments will know who is receiving what
What will happen during the study?
This study is designed in three main phases, as shown below.
Everyone who completes the 1-year study will be asked to join a long-term extension study that checks each participant at 2 and 3 years after their injection.
Who can take part in this research study?
You may be able to join this study if you:
- are 18 years of age or older
- have a diagnosis of degenerative disc disease
- have had chronic low back pain for at least 6 months
- are still experiencing low back pain, despite trying other treatments for at least 3 months.
A study doctor would need to review your medical and surgical history and carry out some additional assessments before deciding whether this study is right for you.
Everyone taking part in the study will be monitored closely by the staff at their doctor’s office. Costs related to your spinal injection procedure(s) will be paid for by the sponsor of the study. You may or may not benefit from the study; however, what we learn from the study may help to improve the treatment of degenerative disc disease in the future.
Want to know more?
To learn more about this study and discuss your eligibility to join, please contact your doctor’s office using the details below. We look forward to hearing from you.