Peek Inside Arizona Pain’s New Stem Cell Study
Therapy for Back Pain Tested.
At Pain Doctor, we are committed to bringing you cutting edge research. One of our partners, Arizona Pain Specialists (APS) has been selected as one of four pain practices nationally to be part of an FDA-approved regenerative medicine study examining chronic back pain. using a single stem cell – gathered through donor marrow stem cells – physicians at APS will use an experimental therapy to treat chronic back pain. it is estimated 15% of Americans have lived with back pain for more than six months.
“Stem cell research within the disc is very exciting. it focuses on addressing the source of the pain, rather than solely the treatment,” says McJunkin. “As an interventional pain doctor i have seen incredible advances in the specialty during the past 10 years – and this study shows we are still at the tip of the iceberg for major advances in pain medicine.”
Mesoblast Limited, an Australian research firm, is sponsoring the trial. Mesoblast is known in the industry for their work with reversing degenerative processes and regenerating disc material in animal studies. The company is well respected for being at the front of regenerative medicine and quality of life research.
“Pain is difficult, and we believe in an aggressive, minimally invasive approach to pain management that incorporates various treatment modalities,” says Dr. Paul Lynch. “The opportunity to research this therapy gives me hope that patients who suffer from conditions like degenerative disc disease may find successful relief.”
APS researchers and others nationally hope to find a new treatment for chronic, debilitating back pain lasting more than six months. Patients with degenerative discs may find long-term relief without being hospitalized for back surgery. Donor marrow stem cells, not to be confused with embryonic stem cells, may reverse damage to the spine seen in degenerative disc disease and other discogenic conditions.
Ryan Tapscott, PhD and director of research at APS, says there are specific criteria for patients who may be included in the study.
“Some 100 patients will be enrolled in the clinical trial nationally,” he says. “We have an expectation to enroll 25 patients. However, we hope to exceed that number. There are a number of inclusion and exclusion criteria that must be met for an individual to participate – the most significant being that participants must have chronic lumbar back pain for greater than 6 months due to degenerative disc(s). Patients can be male or female, 18 years or older, and must have failed at least 3 months of conservative low back pain treatment.”
Tapscott says he is eager for the research to begin because preclinical studies have shown great results.
“Although there is no direct hypothesis, previous study results using animal models have shown that the intradiscal injection of stem cells can help the body’s own cells to help repair the damaged discs of the spine,” he says. “if results of this clinical trial show that this minimally invasive treatment is successful in helping repair the damaged discs of the spine, it could go a long way to replacing the more invasive, complicated surgeries (e.g., spinal fusion) normally used to repair damaged discs. This would only happen with replication from other future clinical trials, but the current trial would serve as the first evidence that this treatment works on humans and opens up a whole new world of potential treatment options.”
Tapscott’s role in the study is considerable, and his enthusiasm is palpable.
“It will be my job to identify and enroll patients, develop specific study logistics so that all study assessments and procedures are completed by each patient enrolled in the study, store and manage all materials needed for study, track each patient throughout the study during the 36 months it lasts, including monitoring their responses to treatment, and acting as liaison between APS and study sponsor, Mesoblast.”
While APS has long participated in studies with vendors, such as St. Jude, this is the first long-term clinical trial for the practice. The notion that information will be gathered at APS that may ultimately create a long-term solution for back pain for people worldwide has the entire staff notably animated.
“Being involved in a study of this caliber, that is so cutting edge, really shows the commitment and dedication of APS to be leaders in pain management,” says Tapscott. “This includes being at the forefront of new, exciting treatments that could benefit our patients and improve their quality of life.”