[Andrews Institute] Dr. Khay Yong Saw Visits Andrews Institute to Oversee Start of Seminal Research Study
GULF BREEZE, Fla. (May 10, 2017) Years of preparation, including the construction of a specialized facility, have paid off at the Andrews Institute for Orthopaedics & Sports Medicine. Today marks the start of an United States Food and Drug Administration (FDA) observed study evaluating the use of stem cells to regenerate knee cartilage. This clinical research study at the Andrews Institute, led by Adam W. Anz, M.D., orthopaedic surgeon and sports medicine specialist, will be conducted in conjunction with the Kuala Lumpur Sports Medicine Center (KLSMC) in Kuala Lumpur, Malaysia, as well as Stanford University, in Palo Alto, California. The study is investigating a cartilage repair technology developed by Dr. Khay Yong Saw, an orthopaedic surgeon who practices at KLSMC.
Dr. Saw recently visited Gulf Breeze, Florida, to oversee final preparations and witness the historic start of the study. The research conducted at the Regenerative Medicine Center through the Andrews Research & Education Foundation will not only be in parallel with research at KLSMC, but will also attempt to replicate clinical treatments already available to patients in Malaysia at KLSMC.
What we are doing for this trial is something we are providing to patient s day in and day out in Malaysia, said Dr. Saw. To date we have done more than 700 cases. A lot of our patients are coming from the Unites States, Canada and Europe to Malaysia because these treatments are not available in their country. The purpose of what we are starting today is to bring this treatment through the FDA to patients in the United States.
While these procedures have resulted in very positive outcomes for Dr. Saw s patients at the KLSMC, the upcoming research study at Andrews Institute will attempt to prove to the FDA that this clinical application is safe and effective, which is the developmental processes for treatments in the United States, and the pathway to offer the treatment to patients in the United States.
Without a FDA trial you cannot start doing these procedures in the United States, said Dr. Saw. We need to go through the FDA pathway, and it is the best way of doing it. While an FDA trial is very expensive, it provides more evidence that the treatment works. We have managed to get the Malaysian government involved and they have helped fund this project. We are very grateful to the Malaysian government, because if we did not have their support, we would not be able to get this started.
Dr. Saw feels that this next step with the FDA will help make this available to patients not only in the United States, but also all around the world. In many instances, the world medical community looks to the FDA for leadership on the approval of medical treatments.
FDA approval provides credibility all over the world, said Dr. Saw. What we are doing here is about taking steps to provide the evidence so that patients all over the world can have the option for a better treatment. It s a matter of sharing knowledge and seeing how this technology can move to the rest of the world. It s important to share knowledge. Individuals must have the desire to push the frontier of medicine. The whole concept of regenerating cartilage is totally different from what s being used now to treat damaged cartilage.
Dr. Anz has been to Malaysia six times to learn about the process and to make preparations to bring this research to the United States. While the two tried and would have preferred to start the research in the Unites States after Dr. Anz s first visit in 2009, it has taken years and incremental preparations at the Andrews Institute to create a solid platform to perform this research.
In Malaysia, Dr. Saw started a randomized, controlled trial on this cartilage repair technology that he finished in 2011 and published in the medical literature in 2012, said Dr. Anz. We took the findings of that study as well as his findings in patients he has treated in Malaysia outside of that study and approached the FDA. Along that same timeline we started building the Regenerative Medicine Center here at the Andrews Institute, and over the past thee years we have conducted research to make sure this facility is ready. Additionally, we are collaborating and making preparations this year with Stanford in California. So although it seems like it has taken us a long time, we have been making a lot of progress along the way.
While this upcoming research study will focus on the regeneration of cartilage, Dr. Saw feels the future application of regenerative medicine procedures in treating a number of orthopaedic problems is limitless.
The stem cell work we are doing is not just designed for the knee, said Dr. Saw. It has the potential of helping all types of tissues; that is the beauty of stem cells. This technology has been used over the last 20 to 30 years by hematologists for bone marrow transplant. We are using it in orthopaedic regenerative medicine to regenerate and repair orthopaedic problems that we currently do not have good solutions.
This clinical research study could take up to six years; however, there may be a possibility to stop the trial earlier if there is a statistical significance present based upon an early analysis of the results.Leave a reply