Posts Tagged ‘multicenter trial of stem cell therapy for osteoarthritis’

Emory Sports Medicine Center Searching for Relief from Osteoarthritis in the Knee

osteoarthritis of the kneeAnyone who suffers from painful osteoarthritis of the knee knows how debilitating the condition can be. Joint stiffness, swelling and pain progress over time as cartilage wears away. Eventually, simple activities, like walking or kneeling, become intensely painful. Lifestyle modification, medication and steroid injections may help alleviate symptoms for some people, but these treatments also carry some risk. Many patients, short of a total knee replacement, are out of options. To address the problem, researchers at Emory Healthcare’s Emory Sports Medicine Center have begun a study to investigate ways in which various cellular therapies may provide relief for this ever-growing population.

The idea behind stem cell therapy is that live cells can be transferred to a patient in hopes of improving symptoms or lessening a disease process. While there have been patients in the past who have experienced positive outcomes, the science has not been refined enough to predictably replicate consistent results.

“Stem cell therapies hold great promise in sports medicine but very little has been proven,” said Ken Mautner, MD, associate professor and director of Primary Care Sports Medicine at Emory Sports Medicine Center. “We want to change that.”

Clinical Trial

Dr. Mautner is the principal investigator at Emory Sports Medicine for the Multicenter Trial of Stem Cell Therapy for Osteoarthritis, or “MILES.” It is the first of its kind and focuses on the basic science of stem cells to treat patients with chronic osteoarthritis of the knee. Researchers will treat and monitor people enrolled in the trial over the course of one year. They hope a combination of patient-reported outcomes, cellular and joint fluid analysis, and MRI reviews will help identify ways to alleviate symptoms and stop the progression of arthritis in order to avoid or delay the need for knee replacement.

Study subjects will be randomly chosen to receive one of four treatments and will not know if they are getting the actual stem cells or a simple corticosteroid injection. Corticosteroids are the current gold standard in treating osteoarthritis. Therefore, this group will act as a barometer for success as results of the stem cell treatments take shape.

Other subjects will be assigned to one of three groups that will each receive a specific type of stem cell injection periodically throughout the year. One injection will be derived from a subject’s own bone marrow, another from their abdominal fat, and a third from donated human umbilical cord tissue cells. All treatments for people enrolled at Emory Healthcare will be conducted at the Emory Sports Medicine Complex in Brookhaven with a local numbing medication.

After each treatment, study subjects will be asked to complete questionnaires to describe how they are feeling, document pain levels, and chronicle any changes in functionality of the knee. Meanwhile, doctors will review MRIs (patients will have three over the course of the year) to see if there are any changes or improvements in the cartilage. Plus, researchers will look at eight different markers in the subjects’ knee fluid. They will analyze the cells and note any positive responses over the course of treatment.

“We aren’t promising subjects any specific result,” Dr. Mautner said. “We need to test all of the different treatments to see if we can identify a superior source of stem cells for the treatment of osteoarthritis and validate its advantages over corticosteroid injections.”

While Emory Healthcare initiated the MILES clinical trial, several other institutions will play a role in its success, including Duke University, Sanford Health, Georgia Tech, and Andrews Institute. The Marcus Foundation announced last year it will fund the study with a $13 million grant.

Clinical Trial Participation

Anyone interested in participating in the study is encouraged to enroll for a pre-screening process to see if he/she qualifies for enrollment. To learn more, visit emoryhealthcare.org/miles or contact Tiffany Dumas, clinical research coordinator with Emory Sports Medicine Center, at 404-778-7881 or tdumas2@emory.edu.