Safety and Efficacy Study of Rexlemestrocel-L in Subjects With Chronic Discogenic Lumbar Back Pain (MSB-DR003)
The Ainsworth Institute of Pain Management has been selected to join a phase 3 clinical trial studying the safety and efficacy of mesenchymal stems for the treatment of back pain. This study is being conducted in several cities around the country; we are the only cite in the tri-state area!
Stem cell therapy is being investigated to treat everything from Parkinson’s Disease to heart disease. There are several different types of stem cell therapy – some that use the bodies on cells to regrow damaged tissue and heal it, while others focus on using pre-grown stem cells that can used like medication to repair the body,
Each of the bones in the spine is cushioned from one and other by intervertebral discs. These discs can become damaged in a variety of ways: a car accident, playing golf, bending down to pick up something heavy, etc. This damage commonly presents as a herniation, aka “a slipped disc.” This will cause the disc to push out into the spinal cord or a nearby nerve root causing a characteristic pain like sciatica. Other times, the disc can develop small tear from the inside causing it to become acutely tender causing pain in and around that disc in the low back – we call this discogenic pain. Over time, damaged discs will lose the nature water contained inside them give them the ability to provide cushion to the spine – this is called degenerative disc disease.
Traditionally, the only way to treat a damaged and painful disc is:
The above treatments can only treat the pain, not repair the damage. Once a disc becomes damaged, it will stay that way…indefinitely. Currently, there is nothing known to man that has been proven to cause a damaged disc to go back to the way it was before the injury.
The scientists at Mesoblast have developed a line of stem cells that can be used “off the shelf” and injected into damaged discs of of the spine. This clinical trial is a prospective, multi center study focusing on whether or not these cells are effective in repairing damaged discs in the spine, potentially eliminating low back pain.
Low Back Pain
Nine out of 10 Americans will experience back pain in their lives and it is the 5th most common cause for a visit to the doctor. Severe back pain can become so debilitating that simple tasks such as bending down to pick something up or walking to the store can become next to impossible. Luckily, there are many treatment options available to help you get back to feeling more like you.
Platelet Rich Plasma (PRP)
PRP is a revolutionary treatment that takes advantage of the natural regenerative properties of the platelets in your blood. In it, the platelets are harvested from your blood and reintroduced into the area you are experiencing pain. PRP has been shown to offer relief from the pain associated with osteoarthritis, tendonitis, rotator cuff and labral tears, and a variety of sports injuries.
Can I Participate in this Study?
Details of the Study
Patients who qualify for the study will be randomized to receive either a single injection of rexlemestrocel-L into a damaged disc, an injection of rexlemestrocel-L plus hyaluronic acid, or an injection of saline. Patients will then be followed for 12 months.
Study Enrollment Form
Official Protocol Name: 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 Discogenic Lumbar Back Pain Through 12 Months
Get Answers to Your Questions at the Ainsworth Institute
The key to finding the proper treatment for any type of pain is getting a proper diagnosis. Not all types of pain respond to the same treatments and the window for improvement can be limited. The experts at Ainsworth Institute offer the most advanced pain management treatments available today, including advanced clinical trials that aren’t yet available to the general public. Call us today for an appointment so we can get you started on your road to recovery.