MedTech Awards 2020

14 GHP / MedTech Awards 2020 , Dec20273 AMNICELL is the first company to recognise the unique capability of human amniotic fluid as an abundant source for novel stem cell products. Helen Ljungdahl Round tells us more about the company’s pioneering work and how it is passionate about shaping the future of healthcare. AMNICELL has developed a unique amniotic fluid stem cell (AFSC) platform from which it develops transformative therapeutics and innovative cosmeceuticals. The company was founded by Dr. Bruce K Young, Professor of Obstetrics and Gynecology New York School of Medicine. His extensive research of amniotic fluid enabled him to recognise the tremendous potential of amniotic fluid and its stem cells in regenerative medicine. Based on more than 10 years research undertaken by Dr. Young which demonstrates the uniqueness of amniotic fluid stem cells vs other stem cells, the company’s primary focus is on the development and commercialisation of transformative therapeutics and innovative cosmeceuticals. It is the first company to use advanced stem cell technology, amniotic fluid and pluripotent allogeneic stem cells to improve health and wellness. Considered an early-stage company, AMNICELL is privately owned and is headquartered in New York City, giving it access to some of the top medical centres and laboratories in the world. New York City is also working on expanding the biotech presence and attracting various biotech companies. Chief Executive Officer, Helen Ljungdahl Round, tells us more about AMNICELL’s pioneering work. Stem Cell Therapy Company of the Year 2020 “The amniotic fluid stem cells have a number of important and unique characteristics that make them promising for a number of therapeutic areas in regenerative medicine,” she begins. “The amniotic fluid in itself is also being considered as a novel ingredient for skin care products and we are currently doing formulation work in this area.” Stem cells are unspecified cells that are pluripotent, meaning they have the potential to develop into many different cell types in the body. In many tissues, they serve as an internal repair system, dividing essentially without limit to replenish other cells. When stem cells divide, each new cell has the potential to become another type of cell with a more specialized function, such as muscle cells, blood cells, or skin cells. Human amniotic fluid derived stem cells have the potential to be used for important therapies for different diseases, conditions and areas of medical need. Unlike other forms of stem cells, they do not require laboratory manipulation to express these qualities. AMNICELL uses the unique characteristics of human amniotic fluid derived stem cells to offer a direct line of cells for therapy. “Our approach is different from other stem cell companies,” Helen continues. “The AFSCs are collected at caesarean births, without impact to mother and child, and then processed and stored in cryopreservation until use.” Before AMNICELL, scientists primarily worked in laboratories with stem cells from animals and recently from humans. However, human stem cells are usually derived from embryos or from chemically reprogrammed “somatic”, “adult” stem cells, or by transforming adult cells into stem cells using a virus to infect the cell. Those cells are difficult to collect, make in large quantities, and keep viable. They are prone to forming tumours, and the potential genetic changes are not fully understood. Other sources of stem cells have limited lineage capabilities and are not able to form all kinds of new cells. AMNICELL provides naturally pluripotent stem cells which are not derived from embryos or transformed adult cells. “Our innovative technology enables us to use the amniotic fluid and stem cells for clinical purposes. We are developing therapies for non-healing wounds, and products for skin care. Other areas of unmet medical needs under consideration are diabetes, lung disease, arthritis, and neurological diseases.” Recently, AMNICELL has been working on a few ground- breaking studies, and Helen is keen to share them with us in order to demonstrate how the AFSC process works. The first is a study in diabetic mice that has now been published. In this study, the team compared healing time and molecular and cellular events of AFSC-treated, vehicle- treated, untreated diabetic, and non-diabetic wounds. The average time to wound closure was approximately 19 days in AFSC-treated diabetic wounds, which was significantly lower than vehicle-treated diabetic wounds requiring on average 27.5 days to heal. “Our next step in wound healing is to proceed with a clinical study assessing the efficacy of AFSC in diabetic foot ulcers and non- healing wounds,” she highlights. In addition, AMNICELL is planning to start a clinical study using AFSC in severely ill intubated Covid-19 patients. Based on the regenerative and restorative properties of the AFSC, the general hypothesis is that the treatment will be able to halt the progression of the disease, improve symptoms, accelerate recovery, and potentially repair damaged lung tissue. “In the laboratory, we are working on developing insulin producing pancreatic beta cells. We have had some early success in- vitro, and plan to continue this laboratory work.” Contact: Helen Ljungdahl Round Website: www.amnicell.com