MEDdesign
An Option for Patients Between Therapy and Major Invasive Surgery

By Danyal H. Nawabi, M.D.

March 11, 2019

Categories: 04-Product Design & Development, Market Access, MEDdesign

More orthopedic patients are highly active and looking to maintain their daily sporting activities. The older generation is living longer and remaining active due to the multiple health benefits of exercise. The younger generation is participating in sports with an increasingly higher level of intensity. The wear and tear on their joints are causing discomfort and creating injuries. The first line of treatment for these patients is typically conservative therapies (i.e., physical therapy, corticosteroids, viscosupplementation, etc). When these treatments are ineffective, there are not many options for patients who have fallen into the “treatment gap” between conservative therapies and surgical intervention.

Many patients are looking for reparative medicine technologies as an option to either delay or avoid the need for surgery. Over the past 15 years, there have been advancements in orthopedic medicine with regards to reparative medicine. There has been much more science and research behind the different options available. It’s important to know that not all tissue and therapies are created equal. There are many different types of tissues that come from your own body (i.e., fat, bone marrow, blood) versus a donor (i.e., amniotic tissue and umbilical cord fluid). The type of tissue, its origin, and how it is processed makes a difference to the final product. FDA clearance status is also important.

Oftentimes patients who are in the treatment gap see advertising for “stem cells” by injection clinics that may offer options at a high cost, using technologies that are not FDA cleared. This year the FDA is ramping up enforcement actions against rogue stem cell clinics that “peddle unapproved treatments” that put patients at risk.¹ In recent months, unapproved umbilical cord stem cells have been linked with infections.²

Fat is making waves in orthopedics and has been used for many years in medicine. Fat is crucial for your health, and the reparative cells within it help to promote a healing environment in response to a tissue injury. Inside of your own fat, there are many different types of cells that are used for healing. These cells need to stay together to work as a functional unit as they do naturally in the body. Fat is known to have a high concentration of reparative cells compared to the other tissues.³ It is relatively easy to harvest from the belly or flanks using a minimally invasive procedure, and it also has a lower risk of rejection and infection. In fact, fat has 100 to 500 times more reparative cells compared to other tissues from your own body (including bone marrow, blood).³ Studies have shown that the quality of fat cells do not decline as much as other tissue sources with age.^4,5,6

With regard to the harvesting procedure, in less than an hour, the fat is extracted from the abdomen or flank “love handles” and injected into the injured area. The minimally invasive procedure can be performed using local anesthesia. The collected fat is then processed in a device using only sterile saline solution to wash, rinse and resize the tissue into smaller clusters while maintaining the natural beneficial properties of the fat. The blood, cell debris and fatty oils are removed, and the desirable remainder of the fat is concentrated. The resulting tissue is injected into the affected area(s) to provide cushion and support. This technology is FDA cleared for use in orthopedics and arthroscopic surgery because it meets the guidelines for minimal manipulation of the tissue and is intended for homologous use.

Not all technologies are the same, and some are not even cleared for use by the FDA. For example, some clinics are offering a type of fat technology that is processed using enzymes and manipulates the cells.^7,8 This is called stromal vascular fraction and is sometimes referred to as adipose-derived stem cells. The technology does not abide by FDA guidance, and the FDA and DOJ have given permanent injunction letters to clinics using this technology.^7,8

Many stem cell clinics are using unproven technologies. It is important to seek the right physicians that are experts in musculoskeletal care based on training and education. These physicians include orthopedic surgeons, physical medicine and rehabilitation, and sports medicine physicians. Orthopedic physicians’ goal is to provide the right treatment options for the patient based on their lifestyle and goals and at a reasonable price with solutions that have strong evidence and are cleared by the FDA.

In conclusion, patients are seeking reparative medicine options. As responsible healthcare providers, it is important to offer options that are using the patient’s own tissue, FDA cleared for use in orthopedics, offered at a reasonable price point, and have strong scientific evidence. Orthopedic physicians should consider offering FDA cleared options to help patients that are trapped in a “treatment gap” and prevent them from seeking unproven technologies by stem cell clinics.

References

Inside Health Policy. FDA Plans Drug Inspection Pilot, Increased Oversight Of Stem Cell Clinics. (December 12, 2018).
Contagion Live. Infections Linked With Umbilical Cord Stem Cells Result in FDA Warning, Product Recall: Public Health Watch. Accessed January 02, 2019. Retrieved from https://www.contagionlive.com/news/infections-linked-with-umbilical-cord-stem-cells-result-in-fda-warning-product-recall-public-health-watch
Caplan A (2013). Mesenchymal stem cells environmentally responsive therapeutics for regenerative medicine. Experimental & Molecular medicine. 45(11):e54.
Beane, O.S., et al. (2014).“Impact of aging on the regenerative properties of bone marrow-, muscle-, and adipose-derived mesenchymal stem/ stromal cells.” PloS one 9.12. e115963.
Stolzing, A., et al. (2008). “Age-related changes in human bone marrow-derived mesenchymal stem cells: consequences for cell therapies.” Mechanisms of aging and development 129.3: 163-173.
Kern, S., et al. (2006). “Comparative analysis of mesenchymal stem cells from bone marrow, umbilical cord blood, or adipose tissue.” Stem cells 24.5: 1294-1301
U.S. Food and Drug Administration. FDA seeks permanent injunctions against two stem cell clinics. Accessed February 25 2019. Retrieved from https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm607257.htm
U.S. Department of Justice. Department of Justice Files Complaints Against Florida and California Companies to Stop Use of Experimental Stem Cell Drugs on Patients. Accessed Feb. 25 2019. Retrieved from https://www.justice.gov/opa/pr/department-justice-files-complaints-against-florida-and-california-companies-stop-use.

About The Author

Danyal H. Nawabi, M.D.

Orthopedic Surgeon

Hospital for Special Surgery

Danyal H. Nawabi, M.D. is an orthopedic surgeon in the Sports Medicine Service. He is a specialist in the fields of knee, shoulder, and hip surgery, performing both arthroscopic surgery and joint replacement. Nawabi completed his medical training at Oxford University in England and residency in orthopedic surgery on the prestigious Percivall Pott Rotation in London, training at the Royal National Orthopaedic and the Royal London Hospitals. He was awarded the Sir Walter Mercer Gold Medal as the top graduating resident in the UK and served as the British Orthopaedic Association Young Ambassador in 2010. Following residency, he completed three years of advanced fellowship training in total joint replacement, sports medicine, and hip preservation at HSS, where he was a double recipient of the Philip D. Wilson Award for Excellence in Orthopaedic Surgery.

Nawabi has special expertise in ACL reconstruction, sports knee and shoulder injuries, hip arthroscopy and robotic-assisted joint replacement in young and active patients. His expertise in sports knee and shoulder surgery was developed in London after completing a dedicated one year fellowship under the supervision of the internationally renowned sports surgeon, Dr. Andy Williams. During this fellowship he gained experience treating elite soccer athletes from Chelsea Football Club and other English Premier League clubs. He has served as an assistant team physician to the New York Red Bulls MLS franchise.

Nawabi’s expertise in hip surgery was developed at HSS during a one year fellowship under the supervision of Dr. Bryan Kelly, who trained him to perform hip arthroscopy. During this year, Nawabi also spent time with Dr. Michael Leunig in Switzerland and Dr. Stefan Kreuzer in Texas gaining advanced training in performing computer-navigated direct anterior hip replacement. He has also been trained to perform hip resurfacing by his mentors in the UK and Dr. Edwin Su at HSS.

A strong research background in knee, hip, and shoulder surgery, Nawabi has authored more than 50 peer-reviewed publications and delivered more than 100 presentations at national and international conferences. He has been recognized with multiple awards by HSS and international societies for his academic accomplishments.

Nawabi believes in offering compassionate care and state-of-the-art solutions to his patients with sports injuries and arthritic conditions of the knee, shoulder, and hip joints.

MEDdesign An Option for Patients Between Therapy and Major Invasive Surgery

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MEDdesign
An Option for Patients Between Therapy and Major Invasive Surgery