A Prospective Safety Study of Autologous Adipose-Derived Stromal Vascular Fraction using a Specializ

Autologous adipose-derived stromal vascular fraction (SVF) has been proposed as a remedy for a number of inflammatory, autoimmune, and degenerative conditions. This week, IFAAS faculty Mark Berman, MD and Elliot Lander, MD shares their latest publication on a Prospective Safety Study of Autologous Adipose-Derived Stromal Vascular Fraction using a Specialized Surgical Processing System that was recently published on the American Journal of Cosmetic Surgery.

Abstract

Autologous adipose-derived stromal vascular fraction procedure had mainly been evaluated in veterinary medicine and outside the United States when this study was initiated. This study looks at adverse events to evaluate safety as its primary objective and secondarily follows efficacy of SVF as deployed through intra-articular injections and intravenous infusions for a variety of orthopedic and non-orthopedic conditions. We hypothesized that autologous SVF deployment using a specialized surgical processing system (the CSN Time Machine system, trademark name for the MediKhan Lipokit/Maxstem system; MediKhan, Los Angeles, California) was safe (ie, minimally acceptable adverse events) and that clinical efficacy could be demonstrated. This was a prospective case series. After institutional review board approval, 1698 SVF deployment procedures were performed between 2011 and 2016 by us and other affiliates with our same system trained by us as a nearly closed sterile surgical lipotrasnfer procedure on 1524 patients with various degenerative, inflammatory, and autoimmune conditions with a majority involving the musculoskeletal system. All outcome test data were collected in an online database over a 5-year period. Our study shows a very low number of reported adverse events and a reduction in pain ratings after 6 months or more across a variety of musculoskeletal diseases and improvements in a variety of other degenerative conditions. Our system for producing adipose-derived SVF therapy for our patients was safe and benefits could be measured for a long time after SVF deployment. Further controlled long-term studies for specific disease conditions with large patient populations are necessary to further investigate the benefits observed.

Keywords

Fat transplant, liposuction, stem cells, stromal vascular fraction

Conclusion

All of us involved in this research network activity of deploying cells and collecting data have been gratified by a large percentage of sincerely appreciative patients. We are confident that the medical and scientific communities will continue to advance cellular therapies and likely find more advanced cell lines or delivery mechanisms. This procedure found its origins in cosmetic/plastic surgery via liposuction. It is exciting that we can use part of our plastic surgical skills working together with a variety of other disciplines to further advance patient care beyond the arena of purely cosmetic or reconstructive surgery. There is no need to limit our surgical skills to purely aesthetic cases. Indeed, many of our affiliates have cosmetic/plastic surgeons as a center of their network of doctors and have found this new aspect of their careers to be incredibly rewarding. We believe we have entered a new era of medicine and the cosmetic/plastic surgeon can play a significant role in advancing cellular therapy.

Although we agree that double-blinded studies would eventually be required to disprove any placebo effect, we believe it is important to demonstrate that there are minimal adverse events associated with SVF treatments and that the risks are acceptable, primarily being related to the method of harvesting and deployment. We can conclude that the deployment of SVF via IV, intra-articular, and into soft tissue is overall safe and well tolerated. In particular, improvement in pain scores and quality of life ratings of teated musculoskeletal conditions served to demonstrate this particularly well. Some conditions had a low follow-up rate making a true treatment effect difficult to evaluate. More stratified data and controlled studies are necessary to investigate treatment outcome for these conditions.

Click here to read the full paper.

Interested to learn more about The New Era of Medicine: Clinical Application of Stem Cells and keen to introduce it into your own clinics?

New Era of Medicine: Clinical Application of Stem Cells

Oct 13-14, 2017

Seoul, South Korea

★ Featuring 3 of the World's Most Renownded Faculties in Stem Cell Therapies: - Mark Berman MD, United States - Hee Young lee MD, South Korea - Kotaro Yoshimura MD, Japan

✔︎ 2 Days Power Packed Training Program: Live Cell Surgical Demonstraiton + Theory + Cocktail Event

✔︎ Featured Topics: - Live Cell Surgical Demonstation on Stromal Vascular Fraction with the Cell Surgical Network's IRB approved protocols. - Learn step by step SVF processing techniques and how the isolated SVF are deployed into a patient - How to uniformly collect patient baselines and follow ups to understand the safety and effects of SVF - Understand how your patients' fat could be the key to their longevity and how cellular based medicine is changing how we treat chronic and acute conditions - Deploying SVF for Orthopedics, Urology and even Cancer - Mitigating the Effects of Concussion, Spinal Cord Injury and Neurological Disorders with SVF - SVF for Plastic Applications - Review of Regulatory Issues in Cell Surgery and Cell Medicine - The Importance of collecting clinical data and how to do so easily

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