The FDA & Regenerative Medicine

By Dr. Brian Shiple

In our quarterly articles we have discussed PRP, stem cells from fat, bone marrow and placental tissues claiming to harbor live juvenile stem cells (which they don’t). We’ve talked about treating soft tissue injuries like the rotator cuff and tennis elbow and badly arthritic joints like the knee and hip. We’ve even talked about how we can successfully treat many spinal conditions like a herniated disc and a pinched nerve that can cause sciatica. One question we get frequently from our patients, are these treatments FDA approved? I was recently asked to speak about the FDA stance on the field of Regenerative Medicine at a national conference. After my research, I have a firm handle on the latest updated position that the FDA has on our tools we use in the Regenerative Medicine Field.

The bottom line . . . the FDA considers PRP to be ok and free from strict over sight unlike fat stem cells and placental tissue products. Bone marrow is also approved by the FDA as long as the doctor does not change it too much or over process it. The industry has a three-year period of research to prove any product that is currently considered a “drug” from being strictly enforced and restricted from use in your doctor’s office. The FDA does not want doctors injecting questionable, unproven stem cell products for medicinal reasons like Autism or Parkinson’s disease, unless it is proven to be safe and effective through rigorous research. The FDA’s job is to ensure the safety of drugs and medical devices. They do not approve treatments. This is governed by the Practice Of Medicine Act created by congress to separate the FDA from doctors’ freedom to choose how to use drugs and devices in the treatment of their patients. However, the FDA was given power over our tissues. If they are manipulated and changed more than a little bit, they have determined that they are no longer tissues, but drugs and need to go through the regulatory drug approval process. Hence, fat stem cells and placental tissue products will need to be licensed by the FDA as drugs and the doctor or company will be looked at as a drug manufacturing company. So, if a placental tissue company wants to continue to sell amniotic tissue products, they must prove to the FDA that they are safe and effective to use for an indication like arthritis. These studies will take a few years to complete and about 1 million dollars per 100 patients. So, I expect many of these placental tissue products to disappear after the three-year study period is over.

In our practice, we have used PRP successfully for 10 years as an effective treatment tool for many conditions we encounter affecting our patients joints, muscles, tendons ligaments, nerves and cartilage. The Regenerative Medicine research world has given us new protocols on how to refine PRP for individual conditions. We no longer use the first generation of PRP, its levels of red and white blood cells were too high for most indications. We are now on our 4th generation of PRP products, our PRP can be painless to inject, as well as very potent anti-inflammatory product. One treatment may be able to calm an inflamed joint for over a year. We have products that are safe and effective to use on swollen entrapped nerves, in areas such as the carpal tunnel or a pinched nerve in the neck from a herniated disc. We can make fibrin glue out of your leftover plasma to seal a vertebral disc tear in your back and then treat the tear with a concentrated PRP or stem cell treatment made from your bone marrow. In our lab, we have tools that can transform your PRP into a very potent healing agent. We use sophisticated cell counters that are analyzed by computerized optical scanners to accurately count your cells, therefore we know what the concentration of our PRP products are. We use specialized blood filters used in pediatric heart surgery that can remove most of the water from your plasma while concentrating specific proteins such as IRAP, A2M and IGF-1 that are more effective at healing larger tears in a tendon, muscle or cartilage or calming down inflammatory conditions like arthritis of the knee. Patients seeking this treatment, have many choices of practitioners who use a bedside PRP kit to try to help heal their condition. However, most are still using the first generation PRP, that we at the Center for Sports Medicine don’t even use any more. They don’t count the PRP cell concentration, so you don’t know if you are getting an optimal treatment for your condition or not. Many don’t use image guidance like high resolution ultrasound to make sure the proper dose is delivered to the right location like we do at the Center for Sports Medicine. Finally, most don’t understand that once the treatment is rendered there are very specific instructions we give our patients to help the patient optimally heal and return to play or work. So if you are researching where to get a Regenerative Medicine treatment in the Philadelphia area, who do you think is doing it at the highest level available in our region? Call the Center for Sports Medicine for a consultation today to see if we have a solution for your painful condition.

Testimonial:

“All my life I have been a very active person. When I was diagnosed with arthritis at the age of 29, life, as I knew it was over. Being told by my orthopedic specialist that I could no longer play sports if I wanted to run around with my children was devastating. I ended up having hip surgery shortly thereafter.

Despite my prior surgery, I continued to suffer from hip pain. As you can imagine, I was frustrated with the limitations this imposed on me and thought I needed a hip replacement. My wife was extremely concerned undergoing this surgery at such a young age and convinced me to seek other options. With her encouragement, I sought the advice of Dr. Delose, who eventually referred me to Dr. Shiple for a non-surgical solution for my advanced hip arthritis and avascular necrosis (AVN) of my hip bone.

I left my initial consultation with Dr. Shiple feeling confident he could help treat my pain without the need for a hip replacement or at the very least prolong surgery. I followed through with a bone marrow stem cell procedure at his recommendation, and I am happy to share the results have been excellent. I have not felt any pain since my treatment with Dr. Shiple. I am now able to play sports again and run around with my kids without having to worry about pain.

Every year for the past 23 years, my friends and I play in our annual Turkey Bowl football game. This year the difference in my ability to play from last year was astounding. Even my friends noticed the change in my performance. Last year, I was very limited in my lateral movement as a quarterback, which made me a sure target for sacks. Needless to say we lost that game. Because of my lackluster performance, the opposing team was confident I would play poorly again. I’m proud to say I proved them wrong and played like my 23 year-old self. I was able to maneuver easily and run side to side without any limitations.

I praise Dr. Brian Shiple and his great team for helping those who are restricted from doing what they love to do because of their condition. I thank my wife every day for encouraging me to be proactive and research alternatives to surgery. I am forever grateful and will continue to be a loyal patient to Dr. Shiple and a firm believer in stem cells.” – M.M.

Credentials:

Dr. Brian Shiple is a highly accomplished sports medicine board certified physician. Dr. Shiple is one of the leading interventional regenerative medicine physicians on the east coast and uses platelet rich plasma and adult stem cells for the healing of musculoskeletal conditions. He has been practicing age management wellness and aesthetic medicine for over 8 years. He has been in practice for 23 years and is a highly sought after speaker, educator, and author.