HairCell Stim

The HairCell therapy available to you will depend on the regulatory status in the individual country where you reside. In the USA and Canada our intent is to start with a three part therapy of (1) in clinic high fidelity bioelectric stimulation with a 510K market cleared stimulator, (2) amniotic fluid injections via DermaPen and (3) amniotic membrane application in fully bald areas of the head and out of the clinic at home we will apply the TeslaBrush electrostatic stimulation device. In other countries where permitted by regulatory authorities a more advanced therapy will be applied which includes repeat injections and applications of the HC-15 fifteen component stem cell based composition which includes exosomes, selected alkaloids, micro RNAs, nutrient hydrogel and hair scalp matrix within a hair regeneration promoting scaffolding. Also outside of the USA and Canada in selected markets we will apply a wider range of bioelectric signals to control expressions of SDF-1, HGF, EGF, IGF-1, PDGF, VEGF, HIF 1 alpha, eNOS, Activin A+B, Follistatin, Tropoelastin and perhaps also GDF-10 and GDF-11.

Clinical trials of the combination therapy described above are just beginning so data on the combination therapy is not yet available and the thus the combination therapy cannot be claimed yet to be either safe of effective. Our team is designed well controlled monitored studies to prove this out. Dozens of papers have been published documenting the benefits towards hair regeneration of the individual growth factor proteins and stem cells we plan to deliver via their controlled release by bioelectric or electrostatic stimulation, direct application via Dermapen or scaffolding matrix or those found within the amniotic fluid and amniotic fluid filled membranes we intend to utilized in the upcoming studies. A humber of studies of documented hair regeneration and other skin healing benefits from stem cell, modified stem cell or stem cell and growth factors mixed compositions application. Over 100 papers have been published on the potential healing benefits of electrical stimulation. See the Related Scientific Articles section of our web site for links to many of the above mentioned peer reviewed papers.

In 1982 Leonhardt Ventures was formed in Minneapolis, Minnesota (formerly H.J. Leonhardt & Co.) as the commercialization arm for inventor Howard J. Leonhardt our Founder. In 1985 Howard read the Body Electric published by Dr. Robert O. Becker and reached out to him to begin research collaboration particularly focused on utilizing bioelectric stimulation to improve blood circulation where needed in the body. In 1986 Leonhardt formed World Medical Corporation and in 1988 World Medical Manufacturing Corporation. In that time frame he began collaborating with a group in England on the development of DeltaVein for improving blood circulation in legs. The team also developed and patented over 20 cardiovascular related devices from 1988 forward. In 1989 working with Dr. Race Kao and Dr. George Magovern they published in The Physiologist their first study on utilizing satellite stem cells to regenerate and heal organs including the heart. In 1999 the team working with Dr. Shinichi Kanno published their first full study in CIRCULATION the Journal of the American Heart Association on the utilization of bioelectric stimulation for precise control of the expressions of blood vessel forming proteins to improve blood circulation. That same year Howard Leonhardt and Dr. Kanno began filing a series of U.S. patents for bioelectric, stem cell, growth factor, nutrient hydogel and matrix based therapies for organ regeneration and recovery. In 2001 the team completed the historic first ever non-surgical stem cell repair of a human heart in The Netherlands working with Dr. Patrick Serruys. They went on to complete and published Pilot, Phase I, Phase II and Phase II/III studies completed in Europe and at 33 centers in the USA. Shortly thereafter Leonhardt began co-collaboration research with Dr. Jorge Genovese one of the leading bioelectric regeneration researchers in the world. Since that time they are the co-inventors of dozens of pending and issued patent claims. In 2012, 2014 and again in 2015 the Leonhardt led team initiated clinical studies in Czech Republic, Switzerland, Germany and Mexico for limb salvage and ulcer wound healing to stave off emanate amputation. In the Czech Republic study they were able to save 12 of 16 legs treated just one time with a stem cell composition. In the study in Switzerland and Germany they worked with a team in Denmark (Wetling) to apply non-invasive bioelectric stimulation to 47 patients with non-healing leg ulcers. They team achieved 95% healing of all ulcers in all patients at 8 weeks. In Mexico they were able to save 7 of 7 legs treated with just two bioelectric signals for only 2 hours 2X a week for 8 weeks. They observed in these leg studies that when the wounds healed the the blood flow improved that their was very healthy hair growth on the treated legs. This launched the start of HairCell in 2016.