Three Questions To Ask About Stem Cell Therapy :
By: Edward G. Loniewski, DO, FACOS, FAOAO
#1- What type of cells are used?
#2- What is the pre and post treatment plans?
#3- How much experience do you have and what are your compiled results?
Stem cell clinics and stem cell experts are filling the internet and the airwaves at a surprisingly rapid rate of growth. Once, these treatments were only available at tertiary medical centers or obscure medical clinics in Europe. Today, almost any medium sized city in the United States has a clinic offering some sort of cell therapy for anything from hair loss to multiple sclerosis. The lack of government control in this burgeoning field of medicine ,and the allure of a “cure” for cash paying patients has made this area of medicine fertile ground for shysters and charlatans ready to take money from desperate patients. A recent study published in the Journal of Knee Surgery in July of 2018 conducted by Dr. Puizzi at the Cleveland Clinic evaluated over 317 clinics in the US advertising stem cell therapy for arthritis of the knee. They were able to contact over 273 of these clinics over the phone and pose as a 57 yo man with knee arthritis. When they asked about the clinics success rates and costs, the answers tended to vary showing that there is little consensus in this field on the costs and results. Furthermore, the cost of the procedure had no correlation to the outcomes reported. So, you did not get what you paid for.
With these wide variations in costs and treatment options for stem cell therapy, it may be helpful to provide the consumer with some standard questions to ask any physician or clinician about stem cell therapy. I have broken these down to three basic questions which should help sort out clinics and clinicians totally dedicated to this area of medicine from those just trying to capitalize on uneducated patients.
What Type of Cells are Used?
Stem cells come from many different sources. In fact, every organ of our bodies produces stem cells. Researchers can isolate stem cells from anywhere in our body or the bodies of other people. Cells can be harvested from fat, bone, skin, synovial tissue, and even blood from menstruation. In addition, stem cells can be obtained from fetal tissue, amniotic fluid and other adults. However, whatever a clinic claims, the FDA has put out some helpful guidelines to determine what type of stem cells are safe and allowed by the FDA for use in the treatment of arthritis. In November of 2017, the FDA put together a document entitled “Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue Based Products: Minimal Manipulation and Homologous Use Guidance for Industry and Food and Drug Administration Staff“ and you can read this whole document by clicking here:
This document helped the FDA navigate this tricky area of medicine while still providing physicians the freedom of providing their “practice of medicine” without overburdening government regulation. The contents of this document outline what the FDA feels is safe and within the guidelines of the “practice of medicine.” They clearly outlined definitions of what they feel fits within these parameters and clearly stated that certain forms of stem cell therapy would now be classified as a drug and were thus held to much higher standards for administration to humans. This document stated that any form of cell therapy other than bone marrow derived was considered a drug. In addition, the FDA issued a warning to clinics and physicians administering stem cells from other sources such as fat and umbilical or amniotic tissue (from babies). However, they provided them with a two year grace period till November of 2019 before they would issue written warnings. Thus, watch out for centers or physician offices offering stem cell therapy from unapproved sources. A physician may use other sources, but only for registered and monitored clinical trials called an IND (Investigational New Drug). In summary, you want to ask what type of stem cell they are using and if they are using anything other than bone marrow, ask if they have FDA approval for research. If they say no, go to another clinic.
Bone marrow is a great source of healing cells because it is the the complete package of mesenchymal stem cells, plasma proteins and growth factors wrapped up in perfect ratios and without the risk of rejection or adverse reactions. These are your own cells for your own healing. What else could be more perfect?
What is your pre and post procedure treatment plans?
Almost any leading researcher and/or physician claiming to be a specialist in a specific therapy will have specific pre and post procedure treatment plans. Stem cells and other cell based therapies are no exception to this rule. Stem cells can be used for a many orthopedic conditions such as arthritis, tendonitis and bursitis, but it only addresses the biochemical issues involved in these conditions. Stem cells are only that...cells. They are not bone, tendon or muscle. They are only cells. They do not straighten crooked bones, strengthen muscles, or replace torn ligaments. However, they help conduct a beautiful symphony of cell to cell communication; reduce harmful chemicals ;and restore the natural balance between cell damage and repair. Thus, it is very important for the clinic or physician to provide you with a comprehensive treatment plan. Muscle weakness, mal-aligned joints, and stiffness need to be addressed with simple treatments such as bracing, heel-wedges, home exercises and even specific therapies. If they just want to provide you with an injection and ask for your credit card, this is a clinic that has not properly prepared to offer these therapies. All of the deficiencies and issues affecting your joints need to be addressed including accessing the joints above and below as well as your spine. Remember the old song that your hip bone is connected to your knee bone. The more areas that are addressed by a thorough physical exam and careful history by a physician skilled in evaluating musculoskeletal issues, the better chance you have of a positive outcome. If they do not offer a comprehensive exam and they are not a board certified specialists in musculoskeletal problems such as an orthopedic surgeon, physical medicine and rehabilitation (PMR) or sports medicine specialists, they may not have the proper training and expertise to perform these exams and you might be better off seeking someone who has these skills. You can quickly find out their credentials and skill set by looking on their website for a biography sometimes called a curriculum vitae. They should have their training listed near the top of this document and also look for a board certification.
What is your experience and your results?
Stem cell therapy has been around since Chernobyl (1986), but it is not something taught as part of a medical school curriculum and very few residency training programs have any structured training programs for this therapy. This may change in the near future, but currently, there is no certifying board or official training program. Thus, training varies greatly, and not everyone who claims they are a stem cell expert is actually an expert. Many clinicians who claim to be an expert only completed a weekend course and may have performed this on a handful of patients without knowing their outcome. Thus, the most reliable training for this procedure is based on the number of procedures and the length of their experience with this therapy. In addition, clinicians need to conduct careful follow up of their outcomes to constantly adjust and improve the techniques and therapies. Clinicians and researchers truly dedicated to this area of medicine are just like artists. They need constant feedback on how they are doing to improve their craft. If the clinician is not using some form of validation testing, they are not dedicated to improving this area of science and you may be better off looking for a clinician who is passionate about constant feedback and improvement. In orthopedics, studies have been performed to identify when a surgeon is considered to be an “expert” or “skilled” in a specific procedure such as joint replacement or hip fracture fixation. There is strong evidence that the number of complications reduce and the outcomes improve when a surgeon performs more than 50 of the same procedures in the same year and the real experts require well over 1,000 procedures to be called an expert. So, don’t be afraid to ask how many procedures the clinician has performed. Experience does count. The number of cells harvested and delivered to a patient are highly dependent upon the skill of the clinician. Cell harvesting numbers can vary well over 300% if the clinician uses the wrong technique.
In summary, this newer area of medicine requires that the consumer take charge and ask the right questions to ensure that they are receiving a true stem cell therapy. This starts with understanding what type of cells are going to be provided. Bone marrow stem cells are the only cells allowed by the FDA and have the safest and most effective results. True stem cell therapy is not just the injection of cells, but the comprehensive evaluation and treatment of the entire person. Finally, the clinician who claims to be an expert must demonstrate that they are really an expert by providing the number of procedures performed and their outcomes of these procedures. These three basic questions will not only help patients choose the best clinician for this form of therapy, but also help keep this specialty in medicine a true specialty.
Edward Loniewski, DO, FACOS, FAOAO is a board certified orthopedic surgeon based in Brighton, Michigan and has vast experience with cell based therapies with over 4,000 procedures performed since 2005 . He evaluates each patient very carefully to ensure they receive the best therapy possible. Not all patients will benefit from cell therapy, and we will be honest and ethical in our evaluation to match the best treatment plan to fit your diagnosis as well as your personal and social goals. We are constantly evaluating and improving our process to provide our patients with the highest quality cell based therapy as we participate in multiple clinical trials and train physicians from all over the country in our techniques. We are passionate about providing the best therapy for the best outcome. If you are interested in a comprehensive evaluation and treatment plan, please contact us by calling 810-299-8552 or visiting us at CellularHealing.net or click HERE.
The Stem-Cell Market for the Treatment of Knee Osteoarthritis: A Patient Perspective.
Piuzzi NS, Ng M, Chughtai M, Khlopas A, Ng K, Mont MA, Muschler GF.
J Knee Surg. 2018 Jul;31(6):551-556. doi: 10.1055/s-0037-1604443. Epub 2017 Jul 24.
PubMed [citation]
PMID: 28738432