CASCADE Study (Stem Cells for Lumbar Discs)

 CASCADE Study

Our center is currently taking part in a medical research study called the CASCADE Study. The study is looking at a potential new treatment (an investigational product) for degenerative disc disease. The investigational product is made from a certain type of adult stem cell and has already produced promising results in a smaller, preliminary study. The main CASCADE Study will involve about 330 adults and will last approximately 3 years. 

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. Although degenerative disc disease can affect any part of the spine, it most often occurs in the lower back and neck. A range of treatment options for the condition exist, however, at the moment, surgery is the only way of preventing its progression.

What is the CASCADE Study?

The CASCADE Study is looking at a potential new adult stem cell therapy. The stem cells being looked at in this study are produced in the human body by the bone marrow. They have been carefully collected from bone marrow samples from healthy adult human donors and grown in a laboratory.

Everyone taking part in the CASCADE Study will receive an injection into the painful disc of either the investigational product, the investigational product in combination with a carrier material called hyaluronic acid or a saline solution (which contains no active ingredients). Treatment will be assigned at random (like flipping a coin) and neither the study participant nor the study staff performing the follow-up assessments will know who is receiving which type of injection. There is a two in three chance of receiving the investigational product and a one in three chance of receiving a saline solution.

Visits to the study center for study assessments will be required before the injection, on the day of the injection, and 1, 3, 6, 12, 18, 24, and 36 months after the injection.

You may be able to take part in the CASCADE Study if you:

  •   are 18 years of age or older
  •   have a documented diagnosis of moderate radiographic degeneration of an intervertebral disc from L1-S1
  •   have had chronic low back pain for at least 6 months,
  •   are still experiencing low back pain, despite trying other treatments for at least 6 months (including physical therapy and medication)
  • Contributing to medical research: People who take part in studies like the CASCADE Study make an important contribution to medical research and have helped improve the treatment of many different illnesses. Although we cannot guarantee that you will benefit directly from taking part in the study, you will be helping doctors understand more about stem cell therapy and degenerative disc disease, which may benefit other people in the future.
  • To learn more about taking part and to discuss whether this study is right for you, please contact me or a member of the study team using the details below.
  • Thank you for your interest in this research.
  • Sincerely,
  • J. Scott Bainbridge, M.D.
  • Principal Investigator
  • The CASCADE Study Team at Denver Back Pain Specialists
  • Call: 303-327-5511