BENEV Announces Journal Pre-Proof on Toxicological Evaluation of Exosomes Derived from Human Adipose
Updated: Jan 11, 2021
MISSION VIEJO, Calif., Jan. 6th, 2021
BENEV Company Inc., an FDA Registered cosmeceutical manufacturer of globally recognized medical professional line, along with their Medical Advisory Board comprised of five global medical leaders, is proud to announce that a Journal Pre-Proof on Toxicological Evaluation of Exosomes Derived from Human Adipose Tissue-derived Mesenchymal Stem/Stromal Cells by ExoCoBio, Inc., an equity invested partner of BENEV was published by Regulatory Toxicology and Pharmacology on May 14th, 2020.
The study was conducted by a team of world renowned scientists, doctors, and institutions including Dae Hyun Ha, Sun-Don Kim, Joon Lee, Hyuck Hoon Kwon, Gyeong-Hun Park, Steve Hoseong Yang, Jae Yoon Jung, Jun Ho Lee, Sang Rae Park, Jinkwon Youn, Sang Hee Lee, Ji Eun Kim, Jihye Lim, Hyun-Kul Lee, Byong Seung Cho, Yong Weon Yi, ExoCoBio Exosome Institute, ExoCoBio Inc. (Seoul, South Korea), Nonclinical Research Institute, ChemOn Inc. (Yongin, South Korea), School of Chemical and Biological Engineering, Seoul National University (Seoul, South Korea), Oaro Dermatology Clinic (Seoul, South Korea), Department of Dermatology, Dongtan Sacred Heart Hospital, College of Medicine, Hallym University (Hwaseong, South Korea), and Guam Dermatology Institute, (Guam, USA).
Several studies report that the therapeutic mechanism of action of mesenchymal 20 stem/stromal cells is mainly mediated by paracrine factors that are released from MSCs such as exosomes. Exosomes are nano-sized extracellular vesicles that are transferred to target cells for cell-to-cell communication. Although mesenchymal stem/stromal cell derived exosomes are suggested as novel cell-free therapeutics for various human diseases, evaluation studies for the safety and toxicity of mesenchymal stem/stromal cell exosomes are limited. The purpose of the study was to evaluate the toxicological profile, including skin sensitization, photosensitization, eye and skin irritation, and acute oral toxicity using exosomes derived from human adipose tissue-derived mesenchymal stem/stromal cells (adipose tissue-derived mesenchymal stem cells - exosomes) in accordance with the OECD guidelines and the principles of Good Laboratory Practice. The adipose tissue-derived mesenchymal stem cells -exosomes were classified as a potential non-sensitizer in the skin sensitization test, UN GHS no category in the eye irritation test, and as a skin non-irritant in the skin irritation test, and did not induce any toxicity in the phototoxicity test or in acute oral toxicity testing. The findings are the first to suggest that adipose tissue-derived mesenchymal stem cells - exosomes are safe for use as a topical treatment, with no adverse effects in toxicological testing, and have potential application as a therapeutic agent, cosmetic ingredient, or for other biological uses.
BENEV’s Exosome Regenerative Complex powered by ExoSCRT™ was developed and designed in tandem with the 4th largest exosome research company in the world, ExoCoBio. The intensive dual action complex is quickly absorbed into the skin, delivering the concentrated power of over 2.5 billion lyophilized exosomes, potent growth factors, peptides, co-enzymes, minerals, amino acids and vitamins. The paraben-free, steroid-free, and hypoallergenic patented technologies and ingredients are clinically proven to rejuvenate and regenerate the skin.
ExoCoBio’s ExoSCRT™, is an innovative patented purification method of separating and refining 0.1 pure exosomes from stem cell conditioned media. The concentration of materials is significantly greater than what can be achieved with a product such as PRP. Studies have shown that this product increases fibroblast production by 180% and collagen production by 300%.
In addition to safety, efficacy, affordability, and utility, the shelf life of Exosome Regenerative Complex powered by ExoSCRT™ makes it appealing to physicians according to Dr. Diane Duncan, M.D., F.A.C.S. Other doctors have also added that: “Lyophilizing exosomes maximizes topical therapeutic potential. Making them idea for treatments” (Dr. Richard Goldfarb, M.D., F.A.C.S.); “These exosomes have potential application across the field of medicine, and it’s exciting to see how it will unfold” (Dr. Richard Jin, M.D., PhD); “The science is clearly demonstrating that exosomes are the wave of the future not just for aesthetics but for many other areas of medicine, and the richest source of this material, by far, is adipose tissue“ (Dr. Randy Miller, M.D., F.A.C.S.); and “By building the low-cost therapy into the overall cost of the treatment, then explaining the role of Exosome Regenerative Complex in their protocol, I see more and more patients returning to have stand along treatments with the product itself for maintenance” (Dr. JD McCoy, NMP).
BENEV’s Exosome Regenerative Complex powered by ExoSCRT™ is a post care “topical use” cosmetic exosome skin solution. Although it is not a drug product that is intended to be injected or delivered intravenously to prevent, treat or cure diseases or medical conditions, BENEV is confident that exosomes would become a key to many medical conditions within a decade or so.
The isolated and purified exosomes in Exosome Regenerative Complex have been accepted by the Personal Care Products Council (PCPC) and International Cosmetic Ingredient Nomenclature Committee (INC), and the name ‘Human Adipose Stromal Cell Exosomes’ was given and published in the International Cosmetic Ingredient Dictionary and Handbook (known as the INCI book). There are at this time no other cosmetic INCI name(s) assigned to exosome products in the market prior to this accomplishment.
BENEV Company Inc. Medical Advisory Board Members:
Richard Jin, MD, PhD, BENEV’s Chief Medical Director, studied at the Boston University School of Medicine, Harvard Medical School and the University of California Irvine. He completed research in the areas of cardiovascular disease, pulmonary hypertension, antioxidant enzyme properties, cell signaling, cellular redox mechanisms, free radical-induced oxidant stress, platelet biology, growth factors, and wound healing. For more information visit www.rjclinicalinstitute.com
Richard M. Goldfarb, M.D, F.A.C.S., graduated from the University of Health Sciences / Finch University, The Chicago Medical School with top honors in Surgery. He completed his surgical training at Northeastern Ohio College of Medicine. He did additional training in cosmetic surgery at the University of Pennsylvania, Department of Plastic Surgery and Yale University. Dr. Goldfarb's 30 years of combined experience in General, Vascular, and Cosmetic Surgery provides his patients with the surgical expertise they are seeking. Dr. Goldfarb established the Center for SmartLipo & Plastic Surgery in 2007. For more information visit www.centerforsmartlipo.com
Diane I. Duncan, M.D., F.A.C.S, obtained her medical degree from the Tulane University School of Medicine. She is certified by the American Board of Plastic Surgery and is a member of several plastic surgery professional societies, including the American Society of Plastic Surgeons (ASPS), the American Society of Aesthetic Plastic Surgeons (ASAPS) and the International Society of Aesthetic Plastic Surgeons (ISAPS). In addition to these affiliations, Dr. Duncan is a fellow of the American College of Surgeons (ACS). Dr. Duncan joined our Medical Advisory Board with over 30 years of experience in private practice as a plastic surgeon. She is an internationally recognized speaker and educator in plastic surgery and has delivered presentations at industry conferences around the world. She has also authored medical journal articles on a variety of subjects in plastic surgery and currently serves as a member of the editorial review board for the Aesthetic Surgery Journal. For more information visit www.drdianeduncan.com
Randy B. Miller, M.D., is a board certified cosmetic and reconstructive plastic surgeon practicing in Miami, Florida. Dr. Miller earned his Bachelor of Arts in psychology and a Master’s degree in clinical immunology and completed medical school at Jefferson Medical College where he graduated at the top of his class. He completed his training in general surgery and otolaryngology - head and neck surgery at Thomas Jefferson University Hospital in Philadelphia. Dr. Miller performed his plastic surgery training at Baylor College of Medicine located within the Texas Medical Center in Houston, which is the largest medical center in the world. Dr. Miller is a former president of the Miami Society of Plastic Surgeons, the Florida Society of Plastic Surgeons, and the Plastic Surgeons Patient Safety Foundation. Having served five consecutive terms on the Board of Directors of the Dade County Medical Association and as a delegate to the Florida Medical Association, Dr. Miller is a member of, and has received presidential appointments from, the American Society of Plastic Surgeons. In addition to his role as a clinical professor in the Division of Plastic Surgery at the University of Miami, Dr. Miller serves as a plastic surgery resident mentor. For many years he has served as the liaison between the University of Miami, Division of Plastic Surgery, and the Miami Society of Plastic Surgeons. Based on his research, publications and 25 years of clinical experience, Dr. Miller has become an internationally recognized expert in the fields of stem cell research and therapy, including human and veterinary tissue regeneration. Dr. Miller provides a uniquely comprehensive approach to aesthetics and age management. For more information visit www.millerplasticsurgery.com
Dr. J.D. McCoy, NMP, received his doctorate in Naturopathic Medicine at the Canadian College of Naturopathic Medicine. He is one of the most accomplished naturopathic physicians practicing aesthetic medicine in the country. He completed an internship in internal medicine in Hawaii, and began specialized training, certification, and externship in cosmetic medicine and light-based therapies. Dr. McCoy has devoted his specialization, passion and his entire practice to the art of less-invasive cosmetic rejuvenation, weight-management, and natural bio-identical hormone therapy since 2003. Dr. McCoy’s principles in the practice of aesthetic medicine include prevention, the use of natural substances (light/energy, nutrients and other natural substances), and the use of the least invasive treatments possible. Dr. McCoy finds innovative solutions that reduce or eliminate the need for more invasive surgery- beautiful results naturally. He is recognized as an innovator and physician trainer for multiple technologies and techniques in cosmetic medicine including but most certainly not limited to a Physician Member: American Academy of Cosmetic Surgery, American Academy of Aesthetic Medicine, American Society of Aesthetic Mesotherapy, International Federation for Adipose Therapeutics and Science. For more information visit www.contourmedical.com
BENEV Company Inc. 1-949-457-2222 www.BENEV.com