Scottsdale, AZ. (PRWEB) February 03, 2014
The team at Arizona Pain (arizonapain.com), has received approval to announce the much anticipated Phase II results of a potential medical breakthrough on the use of stem cells for chronic low back pain. The study, which first garnered international attention two years ago as one of the first trials of its kind in the U.S., has produced positive, promising results.
"We are pleased to report that a clinical study has indicated that a single injection of adult, donor marrow stem cells into degenerating intervertebral discs has reduced low back pain and improved function in trial participants for at least 12 months,” says Dr. Paul Lynch, M.D., Arizona Pain Co-Founder and double-board certified Pain Management physician. “The results of this study, if confirmed, could change the way we treat low back pain.”
Arizona Pain was the first clinic in the U.S. to have been selected for an FDA-cleared study on this advanced treatment. Since then, 100 qualified patients were offered an opportunity to participate in a controlled, double-blind study that monitored any changes in the patients’ degenerative lumbar discs throughout the trial. The stem cells were taken from the bone marrow of a young healthy adult donor, were culture expanded and were administered through a minimally invasive, single injection. Trial participants remained unaware of whether or not they received injections with stem cells or one of the control treatments.
Key findings at 12 months in the trial were reported as follows: improvement in chronic low back pain with reduction in mean pain score; increased proportion of patients achieving 50% reduction in pain score; increased proportion of patients achieving minimal residual back pain; reduced opioid use for pain relief; and reduced need for additional surgical and non-surgical interventions for persistent pain.
“Arizona Pain is incredibly proud to have partnered with the trial sponsor – Mesoblast, a world leader in regenerative medicine (http://www.mesoblast.com) on this sentinel research study,” says Dr. Lynch. “The results are promising and we are hopeful that these findings will be confirmed in a Phase III trial beginning this year."
On January 29, 2014, Mesoblast announced “positive 12 month outcome results from the 100-patient Phase II clinical trial of its proprietary allogeneic, or ‘off-the-shelf’, Mesenchymal Precursor Cells (MPCs) in patients with chronic moderate to severe discogenic low back pain. The results showed that a single injection of MPCs into degenerating intervertebral discs reduced low back pain and improved function for at least 12 months. When compared with controls, MPC-treated patients used less opioids for pain relief, had greater radiographically-determined disc stability, and underwent less additional surgical and non-surgical treatment interventions. MPC treatments also appeared to be well tolerated during the study.”
Mesoblast Chief Executive Silviu Itescu said, “On the basis of these positive results, Mesoblast plans to meet shortly with regulatory authorities in major jurisdictions, including the United States Food and Drug Administration, to discuss product registration trials for the potential treatment of disc degeneration."
More than 6 million patients in the United States alone are currently dealing with chronic back pain that has persisted for at least three months, with around 3.5 million people affected by moderate or severe degenerative intervertebral disc disease. The United States Centers for Disease Control and Prevention’s National Center for Health Statistics reported in 2010 that low back pain was the leading cause of pain, affecting 28% of American adults, and the second most common cause of disability in American adults.
“This study shows we are progressing toward major advances in pain medicine,” says Dr. Tory McJunkin, M.D., co-founder of Arizona Pain and PainDoctor.com. “Stem cell therapy focuses on addressing the source of the pain, rather than just the symptoms. We truly hope this will unlock a vital solution for people suffering from debilitating low back pain,” says Dr. McJunkin.
About Arizona Pain:
The team at Arizona Pain works together to provide relief for various types of chronic pain – including back, neck, facial, joint, hip, and cancer pain, as well as other ailments. These specialists work with one mission in mind: “To change lives by delivering world-class pain management care that we would want for our own mom and dad.” Dr. Tory McJunkin and Dr. Paul Lynch founded Arizona Pain to specialize in pain medicine after a close family member battled severe pain. Arizona Pain remains passionate about treating those who suffer from chronic pain – with the ultimate goal of providing hope and restoring life.
For more information on Arizona Pain’s stem cell study, please contact Kristen Wesley-Lavoie, (kristenw(at)arizonapain(dot)com).