Andrews Institute for Orthopaedics & Sports Medicine in Gulf Breeze, Florida, and the Kuala Lumpur Sports Medicine Center in Kuala Lumpur, Malaysia, have partnered to conduct a randomized clinical trial evaluating the use of a patient’s own stem cells to regenerate knee cartilage.
Andrews Institute & Kuala Lumpur Center Partner in Stem Cell Study
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Lead investigator, Adam Anz, M.D., an orthopedic surgeon at Andrews Institute, noted that is the first multicenter Phase II FDA observed trial that will specifically evaluate the use of a patient’s own stem cells to regenerate knee cartilage.
While stem cells are currently being used and studied for their ability to facilitate healing of ligaments and tendons, this is the first time autologous stem cells will be evaluated in a clinical trial to regenerate cartilage in massive knee cartilage injuries, according to Anz.
“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 Anz. “This clinical trial is a monumental step to get an FDA approved stem cell technology to our patients.”
The study is being conducted in conjunction with the Kuala Lumpur Sports Medicine Center 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 Khay-Yong Saw, M.D., an orthopedic surgeon who practices at the sports medicine facility.
“The whole concept of regenerating cartilage is totally different from what’s being used now to treat damaged cartilage,” said Saw. “We are hoping this study will help the FDA evaluate the safety and the effectiveness of this clinical application.” The study is planned to take up to six years; however it could be stopped earlier if the results show promise or statistical significance.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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