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.
New Study Proves Benefits of Bone Marrow Stem Cells for Knee Arthritis
By: Edward G. Loniewski, DO, FACOS, FAOAO
A very recent publication in the International Journal of Rheumatic Diseases (Int J Rheum Dis. 2017 Jul 27. doi: 10.1111/1756-185X.13139) revealed that a single dose injection of bone marrow stem cells taken from the pelvis provided statistically significant improvement in function and reduction of pain which continued to improve in greater degrees as time progressed. This was a controlled study meaning that it was compared to a similar group of patients who received another commonly accepted treatment for arthritis and in this study it was compared to acetaminophen otherwise known as Tylenol. What was interesting was the fact that the patients who received the stem cell injection into their knee had improvements in their ability to complete normal activities of daily living such as dressing; exiting a car; shopping and bathing at each measurement point and the differences continued to improve as the study progressed. Thus, a difference was noted early in the study and this difference improved more and more as the study went forward. This response is unlike many other treatments provided in medicine especially when it relates to pain relief. Most of the medications or treatments we provide have a "leveling off" effect, but this treatment seems to have a "progressive " effect. The differences in the two groups started very early at 1 week after treatment and continued to improve at 1 month and 6 months after the treatment. Some of the criticisms of this study is that 6 months is still considered to be short term , and there was a lack of reporting how many of the patients did not respond. In addition, this was not a blinded or placebo controlled meaning that both the patient and the physician or researcher knew who received which treatment. Furthermore, this study utilized a pre-treatment drug designed to stimulate stem cells to move from the bone marrow into the bloodstream. This is known as a Granulocyte Colony Stimulating Factor (G-CSF) sold under the trade name Biofilgran. This same medication is used when a stem cell transplant is used for certain blood born cancers. The patients in this study who received this treatment prior to the stem cell harvest tolerated the treatment well with only some minor and temporary bone pain. Despite some of these criticisms, this study is an honest attempt to demonstrate that a simple treatment of stem cells and bone marrow taken from the same patient can provide statistically significant superior relief of pain and an improvement compared to the use of acetaminophen. This effect continues to improve over a prolonged period of time. Every month, new studies like this one helps justify the use of your own stem cells to help you recover from the pain and disability of arthritis. If you would like to read this study yourself, you can find this at: STEM CELL STUDY
Advanced Orthopedic Specialists offer a similar treatment and Dr. Loniewski is offering a pre and post treatment protocol designed to improve your results. We have the most experience providing these treatments than any other stem cell group in the State of Michigan and have been providing cell based therapy to our patients since 2005. We only offer this to patients who fit specific criteria since no single treatment provides optimal results for every patient. Our goal is to provide you with the best treatment for your condition because not all patients are candidates for cell based therapies. To find out if you may be a candidate please download our stem cell questionnaire at: AM I A CANDIDATE FOR CELL THERAPY
and call our office at 810-299-8550 for a comprehensive evaluation.