BROOMFIELD, Colo.–(BUSINESS WIRE)–The Interventional Orthopedics Foundation (IOF), a 501c3 non-profit dedicated to providing education about regenerative orthopedic medicine, recently announced the results of independent lab tests showing an absence of live stem cells contained within placental tissue-derived products. Based on the findings of their research, many physicians are defrauding consumers by claiming that they are injecting “amniotic stem cells,” but are in fact injecting dead tissue. A growing number of physicians nation-wide are claiming that these procedures can provide a cure for everything from arthritis to other areas of chronic pain.
The testing by the IOF looked at the viability of several placental tissue-derived products to determine whether stem cells were actually present. While the products tested are all FDA regulated tissues being sold by many orthopedic sales representatives directly to physician practices, none are registered as live stem cell products, and none actually contained any living tissue in IOF lab tests. Despite this, many physician websites bill the tissues as stem cell therapy.
“Having interacted with many physicians and amniotic stem cell vendors, the disconnect seems to start with overly-aggressive sales representatives who inform physicians verbally, and in writing, that the tissues contain stem cells,” said Christopher Centeno, M.D., and member of the IOF Board of Directors. “The sales reps, neither being physicians nor scientists, confuse research showing that live amniotic tissues do contain small amounts of stem cells with the frozen products that they sell, which once shock thawed at a doctor’s office, contain no living tissue. Unsuspecting patients are being exploited by physicians who then take this limited information and advertise that they are performing stem cell therapy by injecting this dead tissue.”
The absence of stem cells in the products tested was investigated using two approaches. First, the contents of multiple placental tissue-derived products were plated for tissue culture, supplemented with stem cell culture media, and placed into an ideal environment to promote cell growth. Cultures were continuously examined for the presence of stem cells using phase contrast microscopy over a multi-day growth period. No living cells were detected. Second, the products were analyzed using a flow cytometer and the contents were compared against cultured stem cells and a mixed population of bone marrow cells. Again, no clearly defined population of cells were detected within these products.
Interestingly, the amniotic products tested did have a weak growth factor effect, similar but less robust than platelet rich plasma (PRP), a commonly injected substance that helps to promote tissue repair. “This may be the reason some patients report improvement with these amniotic tissue injections,” said Dr. Centeno. “However, if all these products offer are growth factors that can be obtained with a much less expensive PRP shot, it’s unknown why doctors are charging 3-10 times as much for these amniotic “stem cell” injections,” concluded Centeno.
The IOF continues to support physician use of legitimate biologic therapies for orthopedic uses, such as platelet rich plasma and bone marrow concentrate. For more information on the testing, or for more information on the IOF, please visit us at www.interventionalorthopedics.org.
About the Interventional Orthopedics Foundation
The Interventional Orthopedics Foundation was created as a not-for-profit (501)C(3) organization on January 27, 2015. The Foundation’s primary function is to educate and serve as a resource to physicians and the public who seek to understand the growing field of interventional orthopedics, which includes the development and availability of regenerative medicine therapies. For more information on Interventional Orthopedics Foundation, visit: www.interventionalorthopedics.org.