Regenerative medicine is a growing and rapidly expanding field. There is little in the way of regulation and accreditation. There is not yet a formal accreditation process by the American Board of Medical Specialties for Regenerative Medicine. There are boards for Radiology, Internal Medicine, Orthopedics, Family Medicine and Anesthesiology. Having sensed the power of Regen Med, Board certified specialists in these areas have been gravitating to Regenerative Medicine. Prior to accreditation by the American Board of Medical Specialties there are a few organizations which are developing their own board examinations. The goal is to ensure that providers have adequate training and experience to provide quality care. In November 2020, the FDA will be making some recommendations in an attempt to formalize, and standardize production of regen med products. The aim of the FDA is to ensure patient safety by setting standards for manufacture, distribution and marketing of regen med products.
Dr Meglin is a member of the American Academy of Regenerative Medicine and is preparing for and planning to take board offered by the American Board of Regenerative Medicine in summer 2020.. . Dr Meglin’s training has included coursework offered by the American Academy of Regenerative medicine, which was accredited through the Mayo clinic. He has also trained with the regenerative medicine training institute (RMTI) on orthobiologics and medicinal signal cell harvesting from adipose and bone marrow. He has visited production facilities and works with an FDA registered lab. He is a member of Amspa and attends regular continued medical training.
Dr Meglin is doing research in the field and is participating in FDA registered regenerative medicine trials using the IRB and IND pathways. While this is no guarantee of outcomes, Dr Meglin brings extensive experience in needle and catheter based treatments. In short, as mentioned in the consumer reports review of regen med, the field is not yet regulated and practitioners may offer unproven or even harmful therapies. In almost all cases, insurance companies do not reimburse providers or patients for regen med therapies as they are considered experimental.
(Consumer reports Article)
It should be made clear, however, that the FDA has not approved exosomes or stem cells for treatment of patients outside of clinical trials. The use of PRP is outside the scope of FDA regulation. There is a large body of evidence, collected largely outside the US, however, that supports the use of these products. The exosomes used by ART come from an FDA registered lab that is enrolled in FDA trials.
At ART, we try to use only techniques which are evidence based and supported in the scientific literature. These treatments are not FDA approved. They are either outside the purview of the FDA or the FDA has not made a clear statement regarding their use. Please refer to the website offered by the FDA.
We also use generally accepted medical practice techniques, such as review of imaging studies and use of ultrasound used to diagnose your condition. . Dr Meglin is board certified in Radiology with additional qualifications in interventional radiology (needle and catheter based techniques). He did a surgical internship at Walter Reed and has been performing pre and post procedural care for 30 years.
We do offer elective treatments such as IV infusions we believe to be helpful in regenerative medicine based upon largely anecdotal experience. These infusions are not proven nor are they dis-proven to help. Patients report feeling better and we hope to be optimizing the regen med environment for each individual. Hydration is a fundamental principle in pre and post surgical care. Recent studies have suggested that wound healing is facilitated by ensuring adequate vitamin and mineral intake prior to and immediately after surgical procedures.
Adv Wound Care (New Rochelle). 2014 Jan 1; 3(1): 46–53.
Based upon this and other studies, we suggest pre-procedural and post procedural nutritional supplements. We suggest an iv infusion just prior to the procedure. Both of these measures are designed to treat any nutritional deficiencies that may hinder optimal results.
Dr Meglin does not practice internal medicine and is not expert in endocrinology or metabolism. We provide free screening for some conditions to help every patient become the best regenerator of tissues they can be. Recognizing this area as outside of his expertise, Dr Meglin will refer you to general medicine physicians if we find any abnormality on the screening exams. This is part of our overall approach of trying to do the very best we can to optimize your body’s ability to heal and regenerate. Most of the management of metabolic disorders (such as hormone replacement, diet and other metabolic syndromes) is best handled by experts not currently part of the ART practice.