By Ted Swing, Ph.D
The most common type of chronic pain is low back pain. This has several possible causes, such as degeneration of the facet joints in the back or pressure on the spinal cord or branches of nerves which can result from misalignment of the levels of the spine, bulging of the spinal discs, or thickening of bones or ligaments. Another common cause of low back pain is degeneration of the intervertebral discs, a condition known as degenerative disc disease (DDD). This can result from an injury, but sometimes there isn’t a clear cause. Unfortunately, DDD often gets progressively worse and can cause years of chronic pain.
Chronic pain from DDD can be managed with conservative care (chiropractic care, physical therapy) and medications. In some cases, patients undergo surgical procedures such as lumbar fusion, however this is an invasive procedure and in many cases does not resolve the pain. Given the limited treatment options for treating the condition, doctors are excited about the potential to treat DDD with regenerative treatments, such as stem cell injections.
The human body contains stem cells throughout its lifespan, particularly in certain reservoirs such as bone marrow or fat. These adult stem cells are limited in their ability to help the tissues in an intervertebral disc due to the lack of blood flow to the disc. The hope is that by concentrating stem cells and injecting them into a disc affected by DDD, this can delay the degeneration or even restore the healthy structure of the disc.
Mesoblast, an Australian stem cell company, has developed a patented process for harvesting stem cells from the bone marrow of healthy, young adult donors and greatly expanding their numbers in the lab. This allows one donor to produce enough stem cells to treat hundreds of patients. For the past four years, we’ve been working with Mesoblast on a phase II clinical trial to test the safety and efficacy of injecting these stem cells for DDD. We enrolled 11 patients out of 100 across more than a dozen sites in the U.S. and Australia. These patients were followed up for 36 months, and the final visits for this study were recently completed. So far, an interim analysis of patients followed up 12 months after injection showed promising results, including reductions in pain and improved daily functioning among patients treated with stem cells.
We are now working with Mesoblast on the Phase III study of this treatment, testing the efficacy of the treatment in a larger number of patients (330 patients at more than two dozen sites around the US and Australia). When Phase III clinical trials obtain good results, the treatment typically receives FDA approval. Recruitment for this study is ongoing.
In order to qualify for this study, patients must have moderate to severe chronic low back pain from DDD. A number of other potential causes of low back pain, such as facet joint pain or bulging discs, must be ruled out through screening. Additionally, patients who have previously had back surgery may be ruled out. Those who are unable to undergo MRI due to an implanted device are not eligible.
If you are interested in learning more about this stem cell study and whether this may be right for you, you can discuss this study with your pain management providers. For additional information about this study you can contact me directly at TedS@arizonapain.com.
Ted Swing has more than 11 years of research experience in psychology and pain medicine and four years of teaching experience, has published in top psychology and medical journals, and has presented his research at major conferences. He received his Ph.D. in Social Psychology from Iowa State University and has been the Research Director at Arizona Pain since May 2012.
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