Safe, Effective and FDA Allowed Cell Therapy at AOS
Recent news articles in the Wall Street Journal and radio and TV reports of FDA issuing warnings to illegal stem cell clinics have generated a well deserved concern from the public and the media regarding unfounded and potentially unsafe stem cell treatments in the United States. The warnings were issued to unscrupulous and unregulated stem cell clinics in California and Florida. These stem cell therapies have nothing to do with the current therapies available at Advanced Orthopedic Specialists. We are, and always have been compliant with the FDA definitions of regulated cells. This is why we only offer bone marrow derived products as outlined by the FDA Code of Federal Regulations, Title 21, Volume 8 and recently revised as of April 1, 2017. Within this code under section 1271.3, paragraph D and section 4, bone marrow is permitted for use of cellular products. This ruling can be reviewed by clicking onto: FDA Ruling. Thus, our goal of providing safe, effective, ethical therapy to our patients is within full compliance with the FDA. We have been extremely careful and cautious in offering these therapies only to patients who may benefit from these treatments and have tried to provide the safest and most effective protocols to ensure the safe harvesting, processing and delivery of this therapy. We make no wild claims and only treat conditions that may benefit from this therapy. The result is a treatment where over 82.5% of our patients improve with most receiving over 50% improvements from baseline. This still means there are some patients who do not respond, and we try our hardest to identify these patients and recommend another form of treatment. However, we strive to provide all of our patients with the safest, most effective and compliant therapies. As we continue to improve these therapies, we are hopeful that this will provide relief to our patients suffering from bone and joint disease. But, we will always do this in a safe and compliant manner.