Five Costly Misconceptions about Stem Cells for Osteoarthritis By Nathan Wei, MD, FACP Clinical Director Arthritis

Treatment Center Frederick, Maryland 21702 (301) 694 5800 www.arthritistreatmentcenter.com 2nd Opinion Commentary by: Ann Marie Balkanski M.D. Director of Patient Services Stem MD 123 NW 13th ST suite# 206 Boca Raton, FL 33432 561.394.5550 www.stem.md Dr. Nathan Wei: Now, here are a few misconceptions: Misconception #1: You should wait as long as possible before having a stem cell procedure. No. As osteoarthritis progresses, not only is there loss of cartilage but there is progressive disruption of ligaments and tendons that support the joint making the joint biomechanically unstable. Every step you take makes the situation worse. Stem cells inside an arthritic joint already face a struggle to survive but putting them at a biomechanical disadvantage makes this hostile environment even worse. The chances for a good outcome diminish. Dr. Ann Marie Balkanski: Misconception #1) I agree with him on many things he says here, although one thing he did not point out about why you should not wait is the longer you wait the less viable your cells are. This therapy can be compared to why parents save cord blood or use placenta stem cells, so that is in the unforeseen case their child has a "untreatable" disease as an adult they will have these more immature cells from their birth that are more viable. What Dr. Wei is explaining is that the more destruction the harder the stem cells have to work, and I agree, but I disagree that this means they will not work. We are highly concentrating your fluid to get a potent stem cells mix. As I informed you before we cannot guarantee but it is rare that it will not work, especially if you continue our recommended treatment plan. To explain more about why are cells decrease viability with age I will try to explain. All of our cells have our DNA imprint in them. On our DNA there is a region called Telomere which are repeats of protein. These repeats of protein are decreased as we age and scientists believe this is the cause of ageing and this is the reason why cells decrease their viability with age. You can read or do some research on telomeres to learn more and find plenty of peer reviewed articles about it. Dr. Nathan Wei: Misconception #2: Joint replacement surgery is the only option. A good stem cell procedure will postpone the need for joint replacement. It will also save you from having to face the many complications that can occur with a joint replacement. Relief of pain, and restoration of function often occur much faster than with a joint replacement. And there is no foreign hardware that could go bad inside your body. Studies have shown

that many of the joint replacements used today shed micro particles that cause inflammation and lead to abnormal antibody responses to the replacement. Almost like rejection with an organ transplant. (Wooley J, et al. J Bone Joint Surg [Br] 73:25-28, 1970) In addition, as you may know, loosening of the prosthesis can occur more frequently than realized. This often requires a repeat surgery in order to replace the part. Not so bad if youre a 75 or 80- year- old in good health. Not so good if youre 55 and an active athlete. Dr. Ann Marie Balkanski: Misconception #2) Everything he says here I agree with, although I am confused what he means by "not so bad if you're a 75 or 80 year old in good health". I think any repeat surgery is a very detrimental and bad thing compared to the many side effects. This is why we always recommend any alternative before going under a knife. Dr. Nathan Wei: Misconception #3: One method of stem cell treatment is as good as another. No. A number of centers offer stem cell procedures. Many people think that a stem cell procedure involves just a simple jab of stem cells. While some places do this, it is not recommended and I will explain why. You can choose from three primary methods that are offered. First, I'll explain the simple injection. Stem cells are obtained from either bone marrow or fat. Then theyre injected into the affected joint. Thats it. Very simple and also very ineffective. The second method is where the cells from the bone marrow or fat are processed. Theyre mixed with growth factors outside the body. However, the FDA in the United States has strict requirements that cells, when removed from the body not be subjected to treatment with growth factors and other chemicals. This is because of two reasons: the first is potential contamination; the second is the possible introduction of factors that permit unrestricted cell multiplication in other words, cancer. The third method is the guided layering method. With this procedure, imaging techniques like ultrasound are used to mark out the areas for extraction of bone marrow and fat. Specific amounts of two materials, bone marrow and fat, are then carefully removed and processed immediately. Stem cells are isolated and protected from the surrounding environment until they are ready to be used. Ultrasound and miniarthroscopy are then employed to directly visualize the area where the cartilage has been worn away. This is the area that stem cells need to be told to home in on. Special instruments create a specific area of injury in that area of bare bone that tells the stem cells where to go. In addition, bone spurs are removed and the joint is prepared for its new arrivals. This of course requires a sterile environment and a specially trained and coordinated team. While this type of procedure is much more involved, it offers the patient the best hope for a good outcome. This procedure takes into consideration the hostile environment of an arthritic joint. Stem cells have a finite time in which they can multiply and divide. Unless an area of injury is prepared for them to migrate to, and the joint specially prepared for their survival, then the procedure will not work. Dr. Ann Marie Balkanski: Misconception #3) we do NOT simply take out bone marrow and fat and reinject. We DO process it and concentrate the stem cells by putting in a centrifuge. Our process is under a IRB study which, all IRB are approved and regulated by FDA. All our processing is done in a sterile environment to prevent any infections

Dr. Nathan Wei: Misconception #4: Having the right equipment is all a doctor needs to do a stem cell procedure. Not true. Many centers have the equipment to prepare stem cells, but they dont have the experience and training necessary to use them optimally.

You probably know someone who bought the newest computer on the market -- but didn't learn how to use it for a year or more. The same is true with stem cell procedures. The physician may own good equipment, but may not know how to use it correctly. This is why it's important that you choose your regenerative medicine expert wisely and carefully. The best physicians are board-certified in their specialty and have training in arthritis. Ideally they are certified by the American College of Rheumatology and also have received specific training in diagnostic ultrasound and arthroscopy.

Dr. Ann Marie Balkanski: Misconception #4: I am a little confused what Dr. Wei is trying to say the Best way to go about as he doesn't point it out. We have compared different kit systems and our kits are the best in producing the highest concentration of stem cells and growth factors when we compare with others (this is why we have literally switched and switched back to a system that is better even if it cost us more). One thing I do want to clarify that he talks about it the growth factors, the growth factors we use are in your blood. The platelet rich plasma have growth factors in the platelet we are not mixing "growth factors" as Dr. Wei may says is again FDA regulations. I have to disagree and can explain this even further. The one thing we do add is exosomes and a very small about of human growth hormone. The platelets are the major growth factors used and are actually the activators or stem cells. Dr. Nathan Wei: Misconception #5: The center that offers the lowest price is the center to which you should go. Maybe, if price is the most important consideration. Here are two important points to consider. Point #1: The price you see offered may not be for the services you want performed. Before you select a center, decide what you want to accomplish. If you want the physician to just inject stem cells, and hope for the best, you can choose from many centers. On the other hand, if you want the best chance for restoration of cartilage and return to the activities you enjoy, you need to go to an experienced center with a proven track record. One that uses up-to-date techniques, takes into consideration the scientific principles of regenerative medicine, collects data in an organized manner, and presents this information at scientific meetings and in journals. Essentially, its the difference between choosing Motel 6 or the Four Seasons. You need to decide what it is you feel most comfortable doing and what fits in your price range. So remember that the price you see offered may not be for the services you want performed. Point #2: The price youre given may not be what youre looking for. Remember, arthritis is a chronic condition. Its not like getting your gall bladder taken out. Follow-up, both for symptoms as well as measurement of cartilage thickness, is important in order to know the status of the joint. Its important to know how things are progressing. Sometimes a tune-up is necessary. Other times it is not. But you need to know if you may need one. Also, like any other procedure, a stem cell procedure may not work for everyone. Dr. Ann Marie Balkanski: Misconceptions #5) I believe Dr. Wei is basically trying to say "you get what you pay for" and yes I agree BUT unfortunately there are plenty of "quacks" out there doing "voodoo" and we cannot regulate. When you see our center you will see that it is not the fanciest center nor is it large, BUT it is ALWAYS busy. Majority of our patients come to us as referrals or word of mouth from other patients. You may think of it like that busy private secret bar that is hidden but fantastic because of the services it offers. Dr. Purita wants to expand as demand rises but this is why our price, as of now, is quite competitive compared to most.

Just to reiterate Dr. Purita has been doing this for almost 8 years thus he has a great track record and a large database or patients he has seen. Unfortunately being that he is very busy and sees up to 60 patients a day he is unable to dedicate individual time to write more books and articles. Although all you see on his website and blogs is written by himself. He travels the world to lecture and trains doctors literally all over the world. Dr. Wei talks about a "tune up" and being that your arthritis is quite chronic you will need a tune up which is the "boost" given every 4-6 weeks 3 times after the 1st treatment day. In the past 8 years I would say in those that obtain success, 87%, they come back to us only to treat a different joint and not the same. So for these people after the complete treatment a tune up is not needed.