At the forefront of regenerative medicine, Kenneth Pettine, MD, has participated in three FDA biologic studies. He works with Jeffery Donner, MD, at the Colorado Spine Institute . Dr. Pettine is the founder of the Orthopedic Stem Cell Institute, and is a pioneer in the field, with the only Stem Cell methods patent procedure in the nation.
"I'm convinced your body wants to heal itself," says Dr. Pettine. "The problem in orthopedics and spine is there's a paucity of blood supply to the joints or the disc in your back. If you injure your cartilage or disc, it has very little capacity to heal itself."
The key to regenerative medicine in orthopedics and spine lies in the mesenchymal stem cell, because it has the ability to differentiate into osteoblasts, chondroblasts or fibroblasts.
"This may be the most important stem cell in your body," Dr. Pettine explains. "The MSC is the cell that modulates your immune system through its paracrine ability to release numerous growth factors, cytokines, chemokines and inhibitors…It's the conductor and your body is the orchestra."
The use of the MSC to treat orthopedic injuries is standard of care in veterinary medicine, with a good amount of Class 1 data proving safety and efficacy. Dr. Pettine believes humans could also potentially benefit from the use of the MSC to treat orthopedic and spine pathology.
Throughout his career, Dr. Pettine has served as principle investigator for 15 FDA IDE studies focused on non-fusion technology.
He helped with the ISTO Technologies FDA phase one study, which was the first biologic study ever conducted in the human spine in the United States. Using juvenile cartilage cells, the study saw significant reduction in patients' back pain and one-year results have been published.
Dr. Pettine also conducted an IRB study similar to the ISTO trial, utilizing autologous bone marrow concentrated cells to treat discogenic low back pain in 26 patients. This treatment has no FDA issues, as autologous bone marrow concentrated (BMC) cell therapy falls under "the practice of medicine" by the FDA under Section 361 of the Public Health Service Act's provisions.
The 30-minute procedure can be performed in an office or ambulatory surgery center with IV sedation or local anesthetic. Dr. Pettine has published one- and two-year results, and plans to publish three-year follow-up results soon.
The one-year results revealed the cell therapy "significantly reduces lumbar discogenic pain," according to Pettine et.al., Stem Cells 2015; 33:146-156. Out of the 26 patients, only six received surgery 36 months post-injection. Dr. Pettine reported a 72 percent average reduction in Oswestry Disability Index scores and 75 percent average decrease in Visual Analog Scales scores at 36 months.
"It seems to be long lasting," says Dr. Pettine. "We only re-injected two of the 26 patients at three-year follow up."
Of 210 patients with cervical degeneration Dr. Pettine has injected with BMC, about 70 percent reported a 65 percent improvement in pain at one year follow up. Any arthritic joint can be injected with BMC.
Although seeing positive results, Dr. Pettine notes this BMC cell therapy is not intended to replace surgery, but rather serve as a treatment for chronic conditions in patients who want an option prior to surgery. He believes this therapy will become more prevalent in the industry within three years to five years.
"I think it's important for surgeons to be more proactive with [stem cell therapy], because I promise this will not go away," cautions Dr. Pettine. "And if surgeons don't get involved in this, it will be taken over by non-surgeons."