KL surgeon’s technology part of historic FDA study
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KUALA LUMPUR, May 15 — The technology developed by a Malaysian orthopaedic surgeon will soon be part of a historic study to evaluate the use of stem cells to regenerate knee cartilage.
Kuala Lumpur Sports Medicine Centre’s Dr Saw Khay Yong began a randomised controlled trial on this technology, and when completed in 2011, the study was published in medical journals the following year.
His research efforts attracted the attention of the Andrews Institute for Orthopaedic and Sports Medicine in Gulf Breeze in Florida, United States, who invited Dr Saw to the research facility.
On Wednesday, Dr Saw visited the institute and also its Regenerative Medicine Centre, where stem cell research had been conducted for the past three years.
Following Dr Saw’s research, the new research study, headed by the institute’s orthopaedic surgeon and sports medicine specialist, Dr Adam W. Anz, will be done in collaboration with KLSMC in Jalan Dungun, Bukit Damansara.
It will be observed by the US Food and Drug Administration, which will evaluate its efficacy.
Dr Saw said if the technology is approved, it would provide globally recognised credibility.
“Without a FDA trial you cannot start doing these procedures in the United States. While an FDA trial is very expensive, it provides more evidence that the treatment works,” he said in a statement.
Dr Saw also thanked the Malaysian government for helping to kickstart the study by providing funding.
He explained the trial study in the US is something he provides on a daily basis at the KLSMC, with over 700 cases to date.
Most of Dr Saw’s patients come from the US, Canada and Europe since the treatment is unavailable in their home countries.
“This is about taking steps to provide the evidence so that patients worldwide have an option for better treatment,” he said.
“It is a matter of sharing knowledge and seeing how this technology can move on to the rest of the world.”
The FDA-observed clinical research study may take up to six years, but it could end earlier if enough statistical evidence is present in an analysis of the results.
* Editor's note: The print version of this story had an error which has since been corrected here.