Knee Surgery Information

OrthoIndy Participates in Clinical Trial For Knee Surgery

Indianapolis — The FDA has approved a clinical trial of an investigational therapy called Chondrogen™. The investigational therapy has just begun testing in human clinical trials. The goals of the study are to determine safety and whether a single injection of adult mesenchymal stem cells can facilitate the regeneration of meniscal tissue.

 OrthoIndy knee surgeon, Dr. Jack Farr, II is one of five orthopaedic surgeons in the United States and the only surgeon in Indiana who is acting as a principal investigator for the study. On Wednesday, February 22 at 1:00 p.m., Dr. Farr will perform the first two cases in Indiana and part of the first series in the United States at OrthoIndy’s South Office, 5255 E. Stop 11 Rd.

In the United States alone, approximately 800,000 people each year have surgery to remove a portion of damaged meniscus. The meniscus serves to transmit weight across the knee joint, absorb shock, provide lubrication and stabilize the joint. When torn or damaged, the meniscus typically does not heal on its own, and the damaged portion is removed and not replaced during a procedure called a partial meniscectomy.

Most patients respond well to this treatment in the short term, but often develop recurrent symptoms. In addition, over time, arthritic changes not infrequently occur in the joint, due to altered stress in the joint. In preclinical studies, Chondrogenâ„¢ has demonstrated the potential to regenerate the excised meniscus, as well as prevent the typical progression to osteoarthritis associated with this procedure.

THE ADULT MESENCHYMAL STEM CELLS AID IN THE REPAIR OF MENISCAL TISSUE TO REGENERATE THE MENISCUS.

This study, sponsored by Osiris Therapeutics, Inc., is designed to compare the outcome of patients who receive the stem cell injection to patients who receive the current treatment of partial meniscectomy. “We are honored to be working with an investigator of such high caliber as Dr. Farr,” said C. Randal Mills, Ph.D., President and CEO of Osiris. “With his clinical expertise and Osiris’ technology, this study will serve as the foundation for the future pivotal trial and eventual product launch.”

Patients between 18 and 60 years old with pre-operative MRI suggesting the presence of a possible medial meniscal tear may be eligible upon meeting all other inclusion and exclusion criteria. Patients who meet all the entrance criteria will be enrolled in the study after signing an informed consent form that is approved by the IRB (Institutional Review Board) and after the eligible meniscal tear is evaluated during a routine arthroscopy. In addition to standard of care following partial meniscectomy, patients will receive an injection of either the investigational agent (cells) or placebo.

All patients will be followed for a minimum period of 24 months to determine if there is any difference in the function of the knee between those receiving the stem cell injection and those who did not. A person participating in the study can expect to have six study visits in a 24 month period. Subjects participating in this study will be reimbursed for each completed study visit. For further information on this study please contact Vicki Snodgrass, BA, CCRC, Research Coordinator for Dr. Jack Farr, II at (317) 884-5230 or vsnodgrass@OrthoIndy.com

About OrthoIndy – Founded over 40 years ago, OrthoIndy is one of the most highly respected orthopaedic practices in the Midwest. With over 60 physicians providing care to central Indiana residents at twelve locations, OrthoIndy provides leading edge general and sub-specialty orthopaedic care. OrthoIndy physicians also provide care for the Indiana Pacers, Indiana Fever, Indiana Ice, Indianapolis Indians and serve as consultants to the IRL and Champ car circuits. OrthoIndy will open Central Indiana’s only Indiana Orthopaedic Hospital, on March 1, 2005. More information on OrthoIndy can be obtained by visiting www.orthoindy.com.
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