By Pat Anson, Editor
Enrollment has begun in a clinical study of an experimental stem cell therapy that could – if proven successful – revolutionize the treatment of low back pain caused by degenerative disc disease.
About 330 adults with chronic low back pain who have not responded to conventional therapy will be enrolled in the Phase III “Cascade” study at over two dozen medical centers in the United States. Participants will be injected in the lumbar disc with millions of Mesenchymal Precursor Cells (MPCs) – adult stem cells derived from donated bone marrow.
An earlier Phase II study showed that a single injection of a 6 million cell dose of MPCs reduced low back pain and improved function for at least 12 months. Participants also used fewer opioids for pain relief and required less treatment.
“If you look at the study as a whole, people who received the 6 million stem cell injection into the disc, 70 percent of them had a reduction of their pain of 50% or greater. These were clinically relevant changes,” said J. Scott Bainbridge, MD, lead investigator at Denver Back Pain Specialists, one of the clinics participating in the Cascade study.
"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."
Bainbridge says the stem cell injection takes up to two months to stop the pain and inflammation triggered by degenerative disc disease.
“It takes time for the stems cells to normalize the inflammatory condition,” Bainbridge told Pain News Network. “You’re taking a disc that is on a degenerative cascade or path. The stem cells regulate that, they change it from an inflammatory stage to an anti-inflammatory, homeostatic state. It turns on the engine, if you will, to start building and producing some of the things that will help the disc become hydrated and build back some of its structural integrity.”
Degenerative disc disease is the most common cause of low back pain, which develops with the gradual loss of proteoglycan, a substance that cushions the bones of the spine and enables normal motion.
Conventional treatment includes pain medication, physical therapy or surgical intervention such as a spinal fusion. Bainbridge says stem cell injections have the potential to become a frontline treatment, to be used before a riskier treatment such as surgery.
The Cascade study is sponsored by Mesoblast Limited, an Australian company focused on cell-based regenerative medicine. Mesoblast is also developing stem cell treatments for rheumatoid arthritis and diabetic neuropathy, using “off-the-shelf” stem cells from healthy adult donors that do not require tissue matching.
“(There) is compelling evidence that Mesoblast’s stem cell technology has the potential to change the treatment of spinal disease from focusing on surgical reconstruction to biologic regeneration. Physicians and patients are seeking access to a new modality to treat patients with this highly debilitating disease for whom there are limited options,” said Hyun Bae, MD, Medical Director at the Cedars-Sinai Spine Center in Los Angeles, which participated in the Phase II study.
Unfortunately, it could take years for the therapy to win approval from the U.S. Food and Drug Administration. The Cascade study alone is expected to take about three years. For further information about the study and a list of the 25 clinics that are recruiting participants, click here.