Denver Back Pain Specialists today announced that it has enrolled its first patient in a nationwide FDA- cleared adult stem cell study (phase 3) testing an investigational treatment for chronic low back pain associated with degenerative disc disease. The study will test the use of Mesenchymal Precursor Cells (MPCs) – adult stem cells derived from bone marrow that will be directly injected into the lumbar disc.
An estimated 30 million people in the United States suffer from back pain. Degenerative disc disease is the most common cause of low-back pain, which develops with the gradual loss of a material called proteoglycan, which cushions the bones of the spine and enables normal motion.
Most patients with low back pain respond to physical therapy and medications, but in advanced cases, artificial disc replacement or spinal fusion – removal of the degenerated discs and the fusion of the bones of the spine – may be performed. However, these surgeries often are not entirely effective.This minimally invasive stem cell procedure, if successful, may offer improvement to patients with chronic pain from degenerative disc disease.
J. Scott Bainbridge M.D. is Denver Back Pain Specialists’ principal investigator for this study and is leading a team of researchers. He sees the critical need for a minimally invasive solution to a common, debilitating condition. “The clinical program is the first of its kind in the United States and we are very excited by the potential of these adult stem cells to provide a novel therapeutic approach,” Dr. Bainbridge said.
The current Phase 3 study will enroll approximately 330 study participants. Up to 20 participants will be enrolled at the Denver site and the rest at multiple other medical centers throughout the United States. Patients will be followed for 12 months post-treatment.
Denver Back Pain Specialists is enrolling study participants suffering from moderate to severe low-back pain for a minimum of six months and whose condition has not responded to conventional treatments.
Once enrolled, patients are randomly assigned to one of three treatment groups:
- One third (1/3) will receive a 6 million cell dose of MPCs, plus hyaluronic acid, a substance that facilitates the localization and retention of the stem cells;
- One third (1/3) will receive a 6 million cell dose of MPCs alone;
- One third (1/3) will receive only the saline solution.
In an outpatient procedure, patients will receive a single injection of the assigned test agent, MPCs, directly into the center of the target spinal disc and will be monitored for safety and efficacy. Patients will also be monitored using imaging to identify any changes in their disease condition or disease progression. Use of pain medications, self-reports of pain, subsequent surgical interventions and assessments of disability, quality of life, productivity and activity will be evaluated. Repair of the discs, function and reduction of chronic back pain will be assessed in each patient.
Dr Bainbridge took part in the preceding phase 2 clinical trial, which found that the cells were well tolerated. The 6 million cell dose resulted in a greater proportion of patients achieving reduced back pain compared to patients who did not receive the cells.
This study is sponsored by Mesoblast Limited, a world leader in cell-based regenerative medicine. Mesoblast has the worldwide exclusive rights to a series of patents and technologies developed over more than 10 years relating to the identification, extraction, culture and uses of MPCs.
For more information, go to www.denverbackpainspecialists.com or call 303-522-5219.
For additional information on the clinical trial, please see the listing on www.clinicaltrials.gov study identifier number NCT02412735.