Denver Back Pain Specialists (CO, USA) announces commencement of nationwide FDA-cleared Phase III study of mesenchymal precursor cells for chronic low back pain associated with degenerative disc disease
Denver Back Pain Specialists (CO, USA) announced that it has enrolled its first patient in a nationwide FDA-cleared Phase III adult stem cell study to test a 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 USA suffer from back pain. Degenerative disc disease is the most common cause of low-back pain, which develops with the gradual loss of proteoglycan, a material known to cushion the bones of the spine and enabling normal motion.
Existing therapies consist of medications, physiotherapy and in advanced cases, patients resort to artificial disc replacement or spinal fusion (removal of the degenerated discs and the fusion of the bones of the spine). However, these surgeries are not always entirely effective. This minimally invasive stem cell procedure, if successful, may offer improvement to patients with chronic pain from degenerative disc disease.
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J Scott Bainbridge, the study leader, 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,” explained Scott Bainbridge.
The current Phase III 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 USA. All patients will be followed up 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 6 months and whose condition has not responded to current conventional treatments.
Once enrolled, patients are randomly assigned to one of three treatment groups:
- One third 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 will receive a 6 million cell dose of MPCs alone;
- One third 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 also be assessed in each patient.
Additional information on the clinical trial can be found via the www.clinicaltrials.gov study identifier number NCT02412735.
Source: Denver Back Pain Specialists press release: http://www.denverbackpainspecialists.com/denver-back-pain-specialists-physicians-begin-enrollment-in-stem-cell-therapy-study-in-subjects-with-chronic-back-pain/