CASCADE Study – Stem Cell Treatment for Disc Pain
This study is currently closed to enrollment. Thank you for your interest and please check back for new study opportunities!
A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of a Single Injection of rexlemestrocel-L Alone or Combined with Hyaluronic Acid (HA) in Subjects with Chronic Low Back Pain
Principle Investigator: J. Scott Bainbridge, MD
Sub-Investigators: Drew Trainor, DO; Jadon Redington, PA-C; Sophie Baxter, PA-C
Sponsor: Mesoblast, Ltd.
Condition: Chronic Low Back Pain
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 chronic low back pain caused by degenerative disc disease. The investigational product is called rexlemestrocel-l and is made from a certain type of adult stem cell. 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.
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 rexlemestrocel-L?
Rexlemestrocel-L is a type of adult stem cell therapy that is being evaluated as a possible treatment for degenerative disc disease. Stem cells are unspecialized cells that can turn into various specialized cell types. The stem cells used in making rexlemestrocel-L are called mesenchymal precursor cells (MPCs). The MPCs in rexlemestrocel-L have been carefully collected from bone marrow samples taken from healthy human adult donors and grown in a laboratory under very strict conditions.
Here is a link to an article from Mesoblast on the science of stem cells and their use in the treatment of low back pain related to degenerated lumbar discs.
What is the CASCADE Study?
The CASCADE Study is a medical research study looking at the effectiveness and safety of a potential new treatment (an investigational product) for chronic lower back pain. The study will involve approximately 360 patients who are at least 18 years of age.
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.
Those taking part in the CASCADE study have met the following criteria:
- 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.
Thank you for your interest in this research.
J. Scott Bainbridge, M.D.
The CASCADE Study Team at Denver Back Pain Specialists
Phone: 303-327-5511 ext 319