July 6, 2017 – A groundbreaking randomized clinical trial (RCT) evaluating the use of a patient’s own stem cells to regenerate knee cartilage is underway at Andrews Institute for Orthopaedics & Sports Medicine in Gulf Breeze, Florida. The study, led by Adam Anz, M.D., an orthopaedic surgeon at Andrews Institute, is the first multicenter Phase II United States Food and Drug Administration (FDA) observed RCT of its kind.
While early regenerative medicine treatment options utilizing stem cells are currently being used and studied at Andrews Institute to facilitate healing of ligaments and tendons, this is the first time stem cells will be evaluated in a clinical trial to regenerate cartilage in massive knee cartilage injuries.
“In the United States, there are currently no proven treatment options that utilize stem cells to regenerate a patient’s knee cartilage once it has deteriorated,” said Dr. Anz. “This clinical trial is a monumental step to get FDA approved stem cell technology to our patients.”
The study is being conducted in conjunction with the Kuala Lumpur Sports Medicine Center (KLSMC) in Kuala Lumpur, Malaysia, and will be funded in part by the Malaysian government. It will attempt to replicate outcomes from clinical treatments currently available to patients in Malaysia using a cartilage regeneration technology developed by Dr. Khay-Yong Saw, an orthopaedic surgeon who practices at KLSMC.
“The whole concept of regenerating cartilage is totally different from what’s being used now to treat damaged cartilage,” said Dr. Saw. “We are hoping this study will help the FDA evaluate the safety and the effectiveness of this clinical application.”
The RCT will be facilitated through the Andrews Research & Education Foundation, an independent 501(c)(3) not-for-profit entity that serves as the research and education wing of Andrews Institute. The study could take up to six years; however, there may be a possibility to stop the RCT earlier if results show statistical significance.
Baptist Health Care opened the Andrews Institute in 2007. Named for internationally renowned orthopaedic surgeon James R. Andrews, M.D., the Andrews Institute has secured northwest Florida as a cradle for musculoskeletal treatments and research.