Thursday, 27 June 2013

New clinical study to be launched to evaluate cartilage regeneration using stem cells

InGeneron, Inc., an innovator in cell-based technologies for healthcare and veterinary medicine, announced today a study to assess the use of adult adipose derived regenerative cells to enhance cartilage healing after knee surgery. The study will utilize InGeneron’s patented Transpose RTTM system to prepare regenerative cells from the patient’s own fat tissue. Qualified patients are being recruited through the Fondren Orthopedic Group in Houston. Adults age 18 to 68 in the Houston area are invited to apply for enrollment.

According to the American Orthopaedic Society for Sports Medicine, more than 4 million knee arthroscopies are performed worldwide each year. Damaged knee cartilage is difficult to treat and can lead to chronic pain and disability. Dr. Robert Burke, the Principal Investigator of the clinical study and an orthopedic surgeon with Fondren Orthopedic Group in Houston, Texas, thinks using stem cells taken from the patient’s own fat may enhance cartilage healing.

Dr. Burke recently began the study to add patient-derived regenerative cells to the knee during arthroscopic surgery for some patients, while a separate group of patients will have only the surgery. The surgical procedure is one that is commonly used for treating cartilage damage and will be the same for all patients. The group of patients receiving regenerative cells is decided randomly. Dr. Burke will monitor both groups for 12 months after surgery to assess if adding cells improved cartilage healing.

“Articular cartilage, the smooth surface covering the joints at the ends of bones, has no good way of healing on its own,” says Burke. “The body doesn’t create enough new cartilage of the same type to repair the damage.” He explains that better treatments would use ways to help the body make new cartilage. “Stem cells and other regenerative cells that we can obtain from fat have the potential to do that.”

Such regenerative cells can divide and mature to form several types of cells and tissues. These cells are found in multiple places in the body, but fat just below the skin is one of the easiest places to obtain them. A small amount of fat is removed and processed using the InGeneron Transpose RT™ System to separate out the regenerative cells. The separated cells are then immediately placed into the area of damaged cartilage during knee surgery. Once inside the knee, these cells may divide to make new cartilage cells.

While this biological activity has been seen in laboratory studies and veterinary medicine, the study will be one of the first to test the technology in humans for treating cartilage damage. Like other types of stem and regenerative cell therapies, the treatment is not currently licensed for human use in the United States but is registered and used in Europe, Mexico, and other countries. Following the Texas Medical Board’s rules about using adult stem cells for treatment, the study is under the supervision of the research review board at Texas Orthopedic Hospital, where all of the surgeries will occur.

How to enroll
Interested adults age 18 to 68 in the Houston area are encouraged to apply. Certain criteria have to be met to qualify for participation. All those who qualify and want to participate will be enrolled in the study. To apply, contact Dr. Burke by phone 713-436-3488 (office) or email: mc104@fondren.com.

“While it will take two years to complete, we believe we are going to learn something important that will have a positive impact on the future of knee surgery and regenerative medicine.” concludes Burke

About InGeneron
Based in Houston, Texas, InGeneron, Inc. is a leading innovator in cell-based technologies for healthcare, veterinary and life science research. InGeneron’s advanced cell separation technologies enable preparation of adipose-derived regenerative cells, including stem cells, which have the potential to aid physicians and veterinarians in the treatment of a number of diseases, orthopedic injuries and cosmetic procedures. For more information visit http://www.ingeneron.com.

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