Dr. Chris Centeno recently had a reporter ask for an interview with him about Sports Medicine. Dr. Centeno, communicated with him by e-mail and did not grant an interview. He has allowed me to post some of his comments to this reporter (see below). In case anyone hasn't noticed, there is a renewed campaign by the ISSCR as well as some in academia to push for stricter FDA regulation and guidelines. Here's one example: http://www.stemcellpioneers.com/showthread.php?8932-NFL-athletes-are-seeking-unproven-stem-cell-treatments). This is all part of their self preservation program. Stem cell therapy as a practice of medicine is not going to generate grant money or designer type off the shelf products which can be patented.
Dr. Centeno has collected more data on orthopedic stem cell use than any other human being on earth and has sponsored 4 randomised controlled trials he has paid well over a million dollars to complete.
“The issue that you’re struggling with can be boiled down to a simple concept: Is it in society’s best interest to only support medical innovation through the university-pharma pathway where high levels of evidence are required before use or is it better to also support physician based innovation where observation of efficacy followed by increasing levels of evidence are the norm? On the one hand, the university approach has the obvious advantage of evidence first, but the obvious problem of a glacially slow and hyper-expensive process to translate therapies to patients. On the other hand, physician driven innovation has the advantage of much faster clinical translation that’s focused on addressing real world clinical needs and the disadvantage that sometimes the evidence base fails to support the care.
You’re also beginning with the thesis that it’s the norm in sports medicine is to only use therapies that have high levels of evidence, yet this isn’t the case. For example, we have no high levels of evidence to support almost all common orthopedic surgical procedures used in sports medicine including menisectomy, arthroscopic micro fracture, rotator cuff repair, Tommy John elbow surgery, foot/ankle ligament reconstruction surgery, ACL repair, etc… While these procedures have been observed by physicians to work, they lack the type of evidence you want for stem cells. Despite that, all of these procedures are used in your own MIT health plan (or that of your publisher). Stem cells in orthopedics have been following that same medical innovation pathway since the 90s when the first papers were published by Hernigou. Where is the evidence base right now for something like knee arthritis? About the same place it is for knee micro fracture. Our self-funded RCTs should hopefully take that level of evidence up a few notches. However, while the concept that level 1 evidence is required before a therapy is used may be a widely held university belief, it’s clearly not a widely held belief in the community of physicians treating orthopedic injuries. Take for example Allan Mishra at Stanford, who has published in the use of biologics (his focus is PRP). Allan used PRP injections in his clinical practice at Stanford long before there was good evidence to support its use, based on observation of efficacy and that this was less invasive than the planned surgery that didn’t have evidence to support it worked.
In summary, it would be misleading and lack balance to claim only the university point of view on the adoption of new technology. For example, a readers own orthopedic physician is unlikely to share that point of view, given that none of his surgical options are supported by high levels of evidence.”
Dr. Centeno has collected more data on orthopedic stem cell use than any other human being on earth and has sponsored 4 randomised controlled trials he has paid well over a million dollars to complete.
“The issue that you’re struggling with can be boiled down to a simple concept: Is it in society’s best interest to only support medical innovation through the university-pharma pathway where high levels of evidence are required before use or is it better to also support physician based innovation where observation of efficacy followed by increasing levels of evidence are the norm? On the one hand, the university approach has the obvious advantage of evidence first, but the obvious problem of a glacially slow and hyper-expensive process to translate therapies to patients. On the other hand, physician driven innovation has the advantage of much faster clinical translation that’s focused on addressing real world clinical needs and the disadvantage that sometimes the evidence base fails to support the care.
You’re also beginning with the thesis that it’s the norm in sports medicine is to only use therapies that have high levels of evidence, yet this isn’t the case. For example, we have no high levels of evidence to support almost all common orthopedic surgical procedures used in sports medicine including menisectomy, arthroscopic micro fracture, rotator cuff repair, Tommy John elbow surgery, foot/ankle ligament reconstruction surgery, ACL repair, etc… While these procedures have been observed by physicians to work, they lack the type of evidence you want for stem cells. Despite that, all of these procedures are used in your own MIT health plan (or that of your publisher). Stem cells in orthopedics have been following that same medical innovation pathway since the 90s when the first papers were published by Hernigou. Where is the evidence base right now for something like knee arthritis? About the same place it is for knee micro fracture. Our self-funded RCTs should hopefully take that level of evidence up a few notches. However, while the concept that level 1 evidence is required before a therapy is used may be a widely held university belief, it’s clearly not a widely held belief in the community of physicians treating orthopedic injuries. Take for example Allan Mishra at Stanford, who has published in the use of biologics (his focus is PRP). Allan used PRP injections in his clinical practice at Stanford long before there was good evidence to support its use, based on observation of efficacy and that this was less invasive than the planned surgery that didn’t have evidence to support it worked.
In summary, it would be misleading and lack balance to claim only the university point of view on the adoption of new technology. For example, a readers own orthopedic physician is unlikely to share that point of view, given that none of his surgical options are supported by high levels of evidence.”