Portfolio venture
Livercell Logo

LiverCell

LiverCell is a biotechnology pioneer dedicated to eliminating the need for liver transplants through internal organ regeneration. We leverage proprietary bioelectric signaling and stem cell homing to restore full function to patients suffering from end-stage liver disease and cirrhosis.

Contact
Get in touch

(424) 291-2133

12130 Millennium Dr, Los Angeles, California, United States of America 90094

Open in Maps
/ – THE COMPANY

About this Venture

Discover our background, mission, and the world-class research driving our next-generation medical technology.

Prevalence & Market Size

  • 4.5 million Americans have diagnosed liver disease
  • 30 million Americans are suffering from some form of fatty liver disease 5/6th’s undiagnosed.
  • Nearly 2% of all Americans have liver disease
  • 4.5 to 9% of people worldwide have liver disease
  • Liver disease is responsible for more than 2 million deaths worldwide annually.
  • Liver cirrhosis is the 11th leading cause of death worldwide.
  • The Non-alcoholic Steatohepatitis (NASH) market alone is expected to reach $18.3 billion by 2026.
  • Experts forecast the liver disease treatment market to be soon reaching $19.5 billion.

LiverCell History

In the late 1980’s shortly after the publication of the book The Body Electric, Howard Leonhardt LiverCell co-founder, contacted author Dr. Robert Becker to discuss collaboration in research in organ regeneration with a first research project on limb salvage for patients with severe lower limb ischemia. That eventually led to a paper published in 1999 in Circulation the Journal of the American Heart Association working with Dr. Shinichi Kanno and a first patent for bioelectric based limb salvage, new blood vessel growth and ischemia treatment. In 1988 Leonhardt collaborators and advisors Dr. Race Kao and Dr. George Magovern that completed the first case of muscle stem cell repair of a damage heart in large animals which was published in The Physiologist in 1989.

In 1994 Leonhardt teamed up with Dr. Stuart Williams and Dr. Robert Kellar, then both at the University of Arizona, whom are pioneers in biologics research and product development. Dr. Williams secured the first patent for harvesting endothelial cells and stem cells from adipose tissue. Dr. Kellar is a leading developer of regenerative fluids derived from amniotic sources. Both Dr. Wiliams and Dr. Kellar remains key advisors to our innovation accelerator and LiverCell today. That same year Leonhardt began organ recovery research at LABiomed in Torrance, CA in animal labs where he still continues pre-clinical research today.

In 1995 Howard Leonhardt filed the first patent on a stem cell delivery system for internal organs – ProCell. That same year Leonhardt led a team in Australia with Dr. Ken Thomson and Dr. Peter Field that completed the historic first non-surgical repair of an aortic aneurysm (this later led to a 1998 acquisition of this technology by Medtronic AVE as well as a percutaneous heart valve, the stem cell delivery catheter PROCELL and an intravascular lung). That led to meeting Dr. Doris Taylor whom in 1998 published a landmark paper in Nature Medicine on myoblast based regeneration of damaged hearts.

In early 2001 a team led by Leonhardt in The Netherlands working with Professor Patrick Serruys, Dr. Warren Sherman, Dr. Kumar Ravi and Dr Pieter Smits completed the historic first ever non-surgical muscle stem cell base repair of a human heart. This was later published as part of a study in the Journal of American College in 2002 Smits et al. That same year Howard Leonhardt filed the first of his series of bioelectric and/or stem based composition organ regeneration patents. The first one focused on myogenesis (regenerating heart, smooth or skeletal muscle). Around that time Ben Boytor, President of LiverCell, joined the Leonhardt led team and he helped spearhead the effort to get into 35 clinics in the USA and 5 centers in Europe with FDA cleared Phase I, then Phase II, then Phase II/III double blinded, randomized, placebo controlled studies.

He also helped the team achieve the very first FDA clearance for a combination cell and gene therapy product for organ regeneration MyoCell II with SDF1. In 2008 Leonhardt moved from Florida to California and formed an innovation accelerator lab at first headquartered on the campus of the University of Northern California in Santa Rosa, California in their UNC Foundation Science and Technology Innovation Center (UNC STIC). The work in this lab, named Leonhardt’s Launchpads @ UNC STIC, focused on applying everything learned since the 1980’s on bioelectric and biologics based organ regeneration, which had mostly focused on heart and limb regeneration up to that point, to see if it could be improved upon and applied to other organs such as kidneys, liver, pancreas, eyes, lungs, skin, and aortas. Leonhardt has served on the UNC Foundation and University Board of Directors since 1999 and was co-founder of their UNC STIC life science incubator.

In 2012 the Leonhardt’s Launchpads headquarters moved to Los Angeles where it remains today. In late 2015 a branch lab and accelerator was opened in Utah, in 2016 a branch location in Minneapolis opened and in late 2018 in Pittsburgh and Australia. The Leonhardt’s Launchpads accelerator(s) now have 30 startups www.leonhardtventures.com all focused on organ regeneration and recovery and all but one based on same core IP platform of bioelectrics and biologics. 13 products are at clinical stage of development as of May 2019 and another 17 are in pre-clinical studies. Data has been gathered on 220 bioelectric therapy patients as of May 2019 coverage a variety of organs and the team has a goal to have data or enrollment towards data gathering on 500 patients by the end of 2019. Thus far about 83% of patients treated have had successful results and no serious adverse events have been reported. Due to the early stage nature of these pilot studies the company does not make any claims that safety of efficacy has bee proven yet.

The LiverCell team is supported by over 100 innovation accelerator mentors and advisors with decades of experience in organ regeneration, startup and medical device development. We believe no other team brings to the table the bioelectric and biologics based organ regeneration experience that our team has dating back to the 1980’s.

/ A - Our Team

Our Team

  • Howardleonhardt

    Howard Leonhardt

    Executive Chairman & CEO

    Howard Leonhardt is an inventor and serial entrepreneur.  He has 21 U.S. patents for products for treating cardiovascular disease.  His...

    View details
    Howardleonhardt

    Howard Leonhardt

    Executive Chairman & CEO

    Howard Leonhardt is an inventor and serial entrepreneur.  He has 21 U.S. patents for products for treating cardiovascular disease.  His TALENT stent graft developed in the early 1990′s holds a leading world market share for repairing aortic aneurysms without surgery.  His inventions have treated over 200,000 patients in 60 countries.  In early 1999 Leonhardt founded Bioheart  a leader in applying adult muscle stem cells to treat heart failure. Leonhardt holds a Diploma in International Trade from Anoka Technical College.  He attended the University of Minnesota and Anoka Ramsey College.  He holds an honorary Doctorate in Biomedical Engineering from the University of Northern California and is an honorary alumnus of the University of Florida and Florida International University.  He is co-leader of Startup California and Founder and Chairman of The California Stock Xchange (Cal-X)  designed to be the first conscious capitalism stock listing service – www.calstockexchange.com – working through multiple partnerships.  Cal-X units include Cal-X Crowdfund Connect www.calxcrowdfund.com, The Cal-X Funders Syndicate and the Cal-Xelerator and Cal-Stars Business Accelerators www.calxstars.com.   Cal-X Stars is a venture creation lab focused on cardiovascular and social good impact innovations.  The lab has brought forward breakthrough innovations in electrical stimulation technologies for directing stem cell therapies, implantable stem cell and circulatory assist pumps and heart valve decalcification catheters.  His Leonhardt Ventures angels network has raised and put to work over $145 million in 28 companies to date, most of them founded by Leonhardt.  Leonhardt serves as state spokesperson in California for the JOBS ACT and Crowdfunding for Startup California and has given over 60 speeches on the subject.  He has signed a contract to co-host the upcoming CNBC TV Series CrowdFund.   He is testing the waters to run in 2018 as a candidate for Lt. Governor of California.

    Howard Leonhardt is an inventor and serial entrepreneur.  He has 20 U.S. patents for products for treating cardiovascular and heart disease.  These include;  cardiovascular balloon catheters, stent grafts for aneurysm repair, percutaneous heart valves, heart pacemakers with stem cell recruiting capabilities, electrical stimulation devices for promoting blood flow, electrical stimulation device for converting stem cells to heart muscle, stem cell compositions for heart repair, stem cell delivery systems, biological pacemakers and artificial lung catheter.  His TALENT stent graft developed in the early 1990′s holds a leading world market share for repairing aortic aneurysms without surgery.  His inventions have treated over 140,000 patients in 60 countries. In early 1999 Leonhardt founded Bioheart, Inc. www.bioheartinc.com a leader in applying adult muscle stem cells to treat heart failure.  Bioheart has raised over $105 million in paid in capital and additionally $40 million in loans and grants.  Bioheart MyoCell is in Phase II/III clinical trials at 33 leading centers in the USA (The MARVEL Study).  MARVEL Phase II/IIIa part I results were published in the American Heart Journal October of 2011 and demonstrated Bioheart MyoCell patients improved 95.7 meters in exercise capacity over placebo patients receiving optimal CHF drugs, whom declined minus 4 meters.  Leonhardt holds a Diploma in International Trade from Anoka Technical College.  He attended the University of Minnesota and Anoka Ramsey Community College.  He holds an honorary Doctorate in Biomedical Engineering from the University of Northern California and is an honorary alumnus of the University of Florida and Florida International University where he has served on various boards.  He was South Florida Entrepreneur of the Year 2003 and State of Florida Entrepreneur of the Year 2004.  Leonhardt has founded 20 companies to date, most them majority funded by his venture firm Leonhardt Ventures and their associated angel networks www.lventuresnestg.wpenginepowered.com.  These include;  The California Stock Xchange www.calstockexchange.com, Kindheart Lionheart Adventures www.lionheartadventures.com, MyoStim Pacers www.myostimpacers.com, Leonhardt Vineyards www.leonhardtvineyards.com, Leonhardt’s Launchpads www.leonhardtslaunchpads.com, Kindheart Lionheart Media Co. www.kindheartlionheart.com, Stem Cell Bra www.stemcellbra.comand Wine Country Baseball www.winecountrybaseball.com.  Leonhardt helps lead Startup California www.startupcalifornia.org a region of the Startup America Partnership as a spokesperson on the JOBS ACT and Crowdfunding.   He founded the public policy institute The Entrepreneurship Party www.entrepreneurshipparty.com in 2006 and is an independent candidate for the Governorship of California 2014 http://howardleonhardt.nationbuilder.com/ and www.howardleonhardt.org
    Expanded Bio….

    Howard Leonhardt is an inventor and serial entrepreneur.  He has 21 patents for products for treating cardiovascular and heart disease.  These include;  cardiovascular balloon catheters, stent grafts for aneurysm repair, percutaneous heart valves, heart pacemakers with stem cell recruiting capabilities, electrical stimulation devices for promoting blood flow, electrical stimulation device for converting stem cells to heart muscle, stem cell compositions for heart repair, stem cell delivery systems, biological pacemakers and artificial lung catheter.  His TALENT stent graft developed in the early 1990’s holds a leading world market share for repairing aortic aneurysms without surgery.  In early 1999 Leonhardt founded Bioheart, Inc. www.bioheartinc.com a leader in applying adult muscle stem cells to treat heart failure.  Bioheart has raised over $105 million in paid in capital and additionally $40 million in loans and grants. Bioheart MyoCell is in Phase II/III clinical trials at 33 leading centers in the USA (The MARVEL Study).  MARVEL Part I results were published in the American Heart Journal October of 2011 and demonstrated Bioheart MyoCell patients improved 95.7 meters in exercise capacity over placebo patients receiving optimal CHF drugs, whom declined minus 4 meters.

    Leonhardt has founded 21 companies to date, most them them majority funded by his venture firm Leonhardt Ventures www.lventuresnestg.wpenginepowered.com,  and their affiliated angel investor network – see web site for full portfolio.  He holds a diploma in International Trade from Anoka Technical College in Minneapolis, Minnesota and attended Anoka-Ramsey College and the University of Minnesota.  He has received an honorary Doctorate in Biomedical Engineering from the University of Northern California and is an honorary alumnus of the University of Florida and Florida International University, where he has served both as a consulting professor teaching entrepreneurship.  He continues to serve on various boards of all three universities.  He has lectured on entrepreneurship at Princeton University, UCLA, the University of Minnesota and at numerous other campuses.

    In 1983 he was a founding member of American General Medical Corporation and helped build and equip numerous cardiac cath labs around the globe as Export Sales Manager.  In late 1984 he became Vice President of IMA Medical Group in Fort Lauderdale, Florida.  In 1986 he founded World Medical Corp. a firm that assisted cardiovascular device makers to reach export markets.  World Medical Medical Mfg. Corp. founded 1988 developed over 20 products for cardiovascular disease and grew from a few employees to over 500 before merging with Arterial Vascular Engineering of Santa Rosa, California in April 1998 and subsequently selling to Medtronic Vascular in November 1998.  Leonhardt was voted South Florida Entrepreneur of the Year in 2003 and State of Florida Entrepreneur of the Year in 2004.  Spin outs from Bioheart, Inc. he has founded include MyoStim Pacers www.myostimpacers.com in San Diego, a firm based on his patents for enabling a heart to become self regenerating by recruiting stem cells.  Biopace is a biological pacemaker company in development stage in California.  AortaCell utilizes a cell composition to repair aortic aneurysms.  MyoValve utilizes cells for heart valve repair.  EndoCell uses cells to repair damaged arteries.  Peri-Cell utilizes cells to treat limb ischemia in combination with the electronic MyoStim Limb Blood Flow Stimulator. Leonhardt serves on the advisory board of the Cell Therapy Foundation and Adult Stem Cell Research Network.

    Leonhardt’s restaurant Lucille’s Cafe in Weston, Florida www.lucillescafe.com (50% stake with Paul Nunez) has been profitable for nearly a dozen years and is not expanding to food trucks nationwide.

    Leonhardt Vineyards acquired land in Sonoma County in 2000 and produces Gold Medal winning wines with sales of over 6,000 cases a year to outlets such as Trader Joes in California www.leonhardtvineyards.com. Howard’s son Ryan Leonhardt is now running their wine business.  In 2006 Leonhardt formed The Entrepreneurship Party www.entrepreneurshipparty.com a public policy institute for entrepreneurs and is the author of many related articles.  This organization helped lobby for years for the Crowdfunding and Small Company Capital Formation Acts recently passed by the House of Representatives 407 to 17 and 521-1 with the purpose reducing the costs and complexity for small firms raising capital.

    He founded in 2008 The California Stock Exchange www.calstockexchange.com, a firm for assisting small firms to raise capital, which is coupled with Leonhardt’s Launchpads www.leonhardtslaunchpads.com his startup business incubator booster program.  Leonhardt owns 12 collegiate summer league baseball teams and the Wine Country Old Fashioned Baseball League www.winecountrybaseball.com which is modeled after the Cape Cod League for college players seeking to get signed into a major league contract.  He previously owned two indoor arena football league teams, the Miami Morays and the Florida Frenzy.

    In 2011 he started two online radio stations RadioVeronicaUSA www.radioveronicausa.com and RadioSantaMonicaUSA.   His firm Kindheart Lionheart Media Company www.kindheartlionheart.com publishes and retails inspirational books, movies and music.  This includes his own book Dolphin Smiles:  The Legend of Kindheart Lionheart an inspiring fictional tale about a Dolphin that remembers his previous life as a human.  Leonhardt produces regular podcasts of his radio show The Kindheart Lionheart Radio Program which highlights inspiring works and advocates causes for social good entrepreneurs.  Kindheart Lionheart Adventures www.lionheartadventures.com helps organize people to do charity work for others on their vacations, and has adventure packages for auctions to help charitable foundations raise funds.

    Inventor Howard Leonhardt Patents as of March 2020

    Circulatory assist pump – Click here

    Radiation delivery catheter – Click here

    Orthodontic treatment – Click here

    Combination of bioelectrical stimulator and platelet-rich fibrin – Click here

    Method of enhancing myogenesis by electrical stimulation – Click here

    Stimulator, pump & composition – Click here

    Endoluminal prosthesis – Click here

    Pulmonary artery polyurethane balloon catheter – Click here

    Biological pacemaker and implantation catheter – Click here

    Deployment system for miocardic cell material – Click here

    Pro-cell intra-cavity therapeutic agent delivery device – Click here

    Method for engrafting a blood vessel – Click here

    Percutaneous placement valve stent – Click here

    Delivery system for deployment and endovascular assembly of a multi-stage – Click here

    Method of providing a dynamic cellular cardiac support – Click here

    Catheter assembly for treating ischemic tissue – Click here

    Bioelectric stimulator – Click here

    Increased milk production – Click here

    Skin treatment system – Click here

    Tumor therapy – Click here

    Preventing blood clot formation, calcification and/or plaque formation on blood – Click here

    Deployment system for myocardial cellular material – Click here

    Apparatus for engrafting a blood vessel – Click here

    Method of construction of a balloon catheter – Click here

    Tubular graft formed of monofilament fibers – Click here

    Bioelectric blood pressure management – Click here

    Biological pacemaker scaffold – Click here

    System and method for treating inflammation – Click here

  • Ben

    Ben Boytor

    President

    Benjamin Boytor is an experienced Quality Systems Management professional who has spent the past 10 years implementing and maintaining Quality...

    View details
    Ben

    Ben Boytor

    President

    Benjamin Boytor is an experienced Quality Systems Management professional who has spent the past 10 years implementing and maintaining Quality Systems at biologic and medical device manufacturing and R&D locations. Ben began his career working with small biologic start-ups to transition lab and prototype processes into GMP compliant operations for the manufacture of cell-therapy products to be evaluated in clinical trial settings. He has also held leadership roles directing quality operations at medical device and reagent manufacturing plants. Most recently he has implemented Quality Systems for R&D locations and established processes for control of R&D Data Management and Technology Development.

  • Portrait Placeholder

    Dr., 

    Leslie Miller

    Chief Medical Officer

    View details
    Portrait Placeholder

    Dr., 

    Leslie Miller

    Chief Medical Officer

    I have been involved in the field of advanced heart failure for over 35 years, including over 90 clinical trials focusing on all forms of oral and intravenous pharmacologic therapy, including all types of immunosuppression for organ transplantation, and use of mechanical assist devices. My career has evolved over the past 10 years to focus almost entirely on the field of regenerative medicine for organ and tissue regeneration.

    I have had a leadership role in this field beginning with being the founder of the Working Group of Transplant Cardiologists that helped evolve the field into a cardiology-based discipline from purely surgical, and grew to becoming the Program Chair for the International Heart Transplant Society meeting, and eventually the President of this organization. I also took a leadership role in entire the field of transplantation, and became the first non-nephrologist to hold the office of President of the American Society of Transplant Physicians.

    I have also had leadership positions throughout my career including being the Chief of Cardiology for a total of over 15 years at the Universities of Minnesota, Georgetown, and University of South Florida. I have been the Director of Heart Failure, Transplant, and Mechanical Support from my first job at St Louis University, and each of the subsequent programs at which I was Chief of Cardiology. While at the University of MN I created the Lillehei Heart Institute which became the focus of all cardiovascular basic and clinical research there. I have also served as the Director of Fellowship training for over 20 years and mentored over 750 cardiology trainees in my career.

    My academic accomplishments include publication of over 250 manuscripts, 12 book chapters, and lead editor for two major textbooks in the field; Mechanical Circulatory Support and Stem Cell and Gene Therapy for Cardiovascular Disease. I have been involved in clinical and basic research throughout my career, including being the Principle Investigator in 94 clinical trials, including trials funded by the NIH, AHA, as well as industry, as well as on the Steering Committee for over 20 trials and National PI for 4 sstudies. I have been a manuscript reviewer for most major journals in the field of cardiology, and on the editorial board for 3 journals. I have been an abstract reviewer for over 15 years for most major meetings in the field of heart failure and cardiology. I have presented at nearly every meeting of the major society in the field including AHA, ACC, ISHLT, HFSA for the past 20 years, and lectured at most of the major universities in the US and Europe on topics ranging from heart failure to regenerative medicine.

    My basic research began during a 14 month sabbatical with Dr Phillip Halloran in Alberta, Canada studying molecular mechanisms of immunosuppressive drugs, and Dr Alexandra Lucas on vascular biology and the role of a class of peptides known as Serpins in the pathogenesis of cardiac transplant related allograft arteriopathy. I was recruited to be Chief of Cardiology at the U of MN and hired and worked closely with Dr Jennifer Hall on NIH funded research examining the molecular basis of remodeling of patients with end stage heart failure who had an LVAD placed, using microarray analysis of pre and post implant tissue specimens to identify gene expression patterns associated with recovery. We identified the stem cell homing gene, Stromal Derived Factor(SDF-1) as the gene most upregulated in responders vs down regulated in non-responders. I also worked with Dr Jay Zhong on early investigation on the use of scaffolds of matrix imbedded with stem cells, as a superior alternative to intramuscular injection, and retrograde delivery versus intracoronary to develop a cheaper and easier method of delivery of cells or genes. I have collaborated with Dr Doris Taylor on her work on use of stem cells for cardiac regeneration, which spawned my evolution to regenerative medicine becoming the focus of my career and research interests. I became the site PI for the NHLBI SCOR grant on the first use of allogeneic mesenchymal stem cells in patients with heart failure at the time of implant of a ventricular assist device in 2008. Since that time I have been involved as the site or national PI for 12 trials of stem cell of gene therapy for cardiovascular disease, including not only heart failure but also acute MI, Peripheral Arterial Disease in addition to heart failure, using adipose derived and bone marrow cells, as well as currently the allogeneic MSCs in the DREAM trial, but also five different genes including SERCA-2A, Neuregulin, SDF-1, as well as a combination of S100A, SDF, and VEGF.

    My intense interest in regenerative medicine led to me creating the outline for a textbook on this topic and became the lead editor for what is currently one of the leading textbooks in the field entitled, Stem Cells and Gene Therapy for Cardiovascular Disease. This led to extensive research on all areas of this field including tissue engineering, and a detailed grasp of nearly all the current and future strategies to enhance cell retention and harness native organ and tissue regeneration.

    During the research for this book I became aware of the unique approach of using bioelectric stimulation to stimulate the upregulation in the local tissue of a variety of very pro-regenerative proteins, including SDF to enhance homing of stem cells to the target area, but also the unique signaling to enhance differentiation and proliferation of these stem cells. This interest led to collaboration with Howard Leonhardt, who is a pioneer in this concept and becoming the PI on a grant funded at the University of Utah to study cardiac regeneration with the use of Biolecrtric Stimulation(BES). We first examined iPSC-derived cardiomyocytes to prove the efficacy of the stimulation in upregulation of a set of 15 target protein expression by QPCR analysis, and will use his very novel approach to use deliver BES plus stem cells and a combination of most individual agents shown to play a role in stem cell function and organ regeneration including exosomes, mRNA, matrix, as well as amniotic fluid. I have become the Chief Medical Officer for Leonhardt Ventures and in this role I am involved in all of the research with the use of the combinatorial approach to organ and tissue regeneration across nearly all organs and diseases, including collaboration and grant applications with many universities and research labs. We have worked to identify genes that are uniquely important in specific conditions, such as IGF for brain injury and recovery, as well as liver regeneration. We are focusing on GDF-10,11 as potentially important in aging and regeneration in most organs.

    This broad interest and background in basic science and molecular biology has led to the collaboration in this grant to study molecular mechanisms of erectile dysfunction using bioelectric stimulation.

    Positions and Honors

    1982-1996
    Saint Louis University: Assistant Professor Medicine and Surgery;

    1982-1996:
    Director of the Coronary Care Unit

    1986-1989:
    Associate Professor of Medicine and Surgery; Director of the Heart Transplant and Mechanical Support Program

    1989-1996:
    Professor of Medicine and Surgery

    1996-1997:
    Sabbatical leave: University of Alberta, CA with Dr Phiillp Halloran focused in immunology and immunosuppression, and Dr Alexandra Lucas on vascular biology

    1997-2007:
    Professor and Chair of the Division of Cardiology, Univ of Minnesota;
    Director of the Heart Transplant and Mechanical Assist Program, and
    Director of the Cardiology Fellowship Program

    2005-2007:
    Founding Director of the Lillehei Heart Institute, U of MN

    2007-2010:
    Chair of the combined Division of Cardiology Georgetown University and Washington Hospital Center
    Proctor Harvey Distinguished Professor of Cardiology, Georgetown Univ
    Director of the Heart Transplant and Mechanical Support Program
    Director of the Cardiology Fellowship Program

    2010-2013:
    Chairman the Department of Cardiology Univ South Florida
    Edward C. Wright Professor of Cardiovascular Medicine
    Director of the Cardiology Fellowship Program

    2012-2013:
    Director of the Cardiovascular Institute

    2013-2016:
    Director of Heart Failure Morton Plant Hospital

    2016-current:
    Chief Medical Officer, Leonhardt Ventures

    1988-2009:
    Founder and Chair: Working Group of Transplant Cardiologists

    1995-1997:
    President of American Society of Transplant Physicians

    1997-1998:
    President of International Society of Heart and Lung Transplantation

    1999:
    Citation of Merit: University of Missouri, Outstanding Alumnus

    1999-2006:
    Board of Directors of Cardiovascular Translational Research Society

    2014-:
    Chairman of the Board of the Alliance for the Advancement of Stem Cell Research

    2013-:
    Board of Directors International Congress of Cardiology

    Contributions to Science

    I began my career in 1982 at St Louis University when it was one of only three institutions using mechanical ventricular assist devices and only a very few doing heart transplantation. I helped evolve the field from purely surgical management, to now the majority of care being directed by cardiologists. Following my sabbatical on immunosuppression with Dr Phillip Halloran, I helped develop novel strategies for transplant immunosuppression, including withdrawal of corticosteroids in maintainance immunosuppression. This included collaboration with the development of the first molecular based test for rejection based on microarray analysis of both renal and cardiac allografts. I was a part of the first use of intravascular ultrasound to study the allograft coronary disease in heart transplant patients and was the founder of the first federally funded national database to study outcomes with heart transplantation, that evolved to become the REMATCH database, which remains the standard in the field.

    I helped advance the field of mechanical circulatory support by establishing milestones such as the first patient discharged from the hospital with a VAD, and was the national PI on the first device in the field to change from pulsatile to continuous physiology. I have been an advisor to nearly every device manufacturer and personally managed patients supported with every VAD brought into clinical trials for 30 years.

    I have mentored over 750 cardiology fellows during my career, many of whom have authored countless abstracts and made presentations at national meetings, as well as several who were awardees of grant funding from both the NIH and AHA, as well as industry.

    Additional Information: Research Support and/or Scholastic Performance

    I have had research support as Co-PI from the NHLBI, ranging from SCOR grants to RO-1, the Am Heart Association, as well as an extensive list of industry funded research from nearly all companies involved in the pharmacologic or biologic agents as well as mechanical devices for the treatment of heart failure or heart transplantation.

    I served as a reviewer for SBIR grants for the NIH for four years (199-2003)

    Current Research Support

    I am currently the site PI for the following clinical trials in stem cell or gene therapy for CV Disease:

    • Mesoblast Phase III DREAM study of allogeneic MSCs for patients with HF
    • Athersys Phase II study of Bone Marrow derived Multi-potent Allogeneic Progenitor cells for NSTEMI
    • Juventas Phase II STOP-PAD study of SDF gene therapy for Peripheral Arterial Disease
    • Renova Phase II study of Adenyl Cyclase gene for patients with heart failure
    • Biocardia CARDI-AMP Phase III study of bone marrow MNCs for heart failure
    • Intrexon study of multi-gene therapy, SDF, S100A, and VEGF, for patients with heart failure

    Industry Collaborative Roles (past 5 years)

    • Steering Committee Intrexon Pharmaceuticals (2017-)
    • Steering Committee Juventas Pharmaceuticals (2011-)
    • Chair of the Steering Committee TargaCell Inc, (2016-)
    • Steering Committee Black Beret Lifesciences (2017-)

    Society Memberships

    • American Heart Association
    • American College of Cardiology
    • International Society of Heart and Lung Transplanation
    • International Congress of Cardiology
    • Heart Failure Society of America
    • American Society of Transplant Physicians
    • Society for Cardiovascular and Translational Research
    • Alliance for the Advancement of Cell Therapy

    Journal Reviewer

    • New England J of Medicine
    • Circulation, Heart Failure
    • Journal Am Coll of Cardiology
    • Journal of Heart Failure of JACC
    • Journal of Heart Failure
    • Journal of Heart and Lung Transplantation
    • European Journal of Heart Failure
    • Cochrane Database
  • Jorge Genovese

    Dr., 

    Jorge Genovese

    Vice President Bioelectric Regeneration Research

    Over the last 35 years, Jorge Genovese has focused on cell and molecular biology in tissue engineering and regenerative medicine....

    View details
    Jorge Genovese

    Dr., 

    Jorge Genovese

    Vice President Bioelectric Regeneration Research

    Over the last 35 years, Jorge Genovese has focused on cell and molecular biology in tissue engineering and regenerative medicine. It is noteworthy that he has worked on numerous organ development projects in the academic and private sectors, including at the University of Pittsburgh, in the Cardiac and Molecular Biology Laboratory, at the University of Utah, where he served as a director and professor of surgery, as well as several companies.

    At the University of Buenos Aires’ Cell Biology Institute, he created the first organotypic cultures of keratinocytes in Latin America in 1985. In 1999, a dermo-epidermic device equivalent to those developed in central countries was developed. A genetically modified version was produced soon after. In order to achieve these goals, he built the first tissue engineering laboratory in the region, at Craveri Inc., where he studied keratinocyte culture, keratinocyte application methods, epidermal stem cells isolation, cornea epithelium and chondrocyte culture, and myoblast culture for patient application. Over the past 20 years, he has been involved in bioelectrical modulation of gene expression and translational medicine projects.

    He began his academic career as a teaching assistant during his second year of medical school and went on to hold professorships in the United States, Italy, Uruguay, and Argentina.

    Over the course of his career, Dr. Genovese has held leadership positions in academia, industry, and government. He served as Vice President and Chair of numerous committees of the Tissue Engineering International & Regenerative Medicine Society (TERMIS). From 2002 to 2012, he served as Honorary President of the Chinese Academy of Medical Sciences’ Tissue Engineering Committee. He has served on several editorial boards. He has developed novel technologies and patented a number of inventions in the field of biological use of electricity.

  • Stuart williams

    Dr., 

    Stuart K. Williams

    Vice President Biologics Research

    Dr. Stuart K. Williams II received his Ph.D. in Cell Biology from the University of Delaware, followed by...

    View details
    Stuart williams

    Dr., 

    Stuart K. Williams

    Vice President Biologics Research

    Dr. Stuart K. Williams II received his Ph.D. in Cell Biology from the University of Delaware, followed by postdoctoral training in Pathology at Yale School of Medicine. From 1980 to 1990, he held a faculty appointment at Jefferson Medical College, where he served as Director of Research in the Department of Surgery.

    In 1990, Dr. Williams joined the University of Arizona, where he founded the Biomedical Engineering Program—bridging research and education between the College of Engineering and the Medical School. He held joint faculty appointments in Biomedical Engineering, Surgery, Physiology, and Materials Science and Engineering.

    In 2007, Dr. Williams was appointed Director of the newly established Cardiovascular Innovation Institute—a collaborative initiative between Jewish Hospital and the University of Louisville. There, he launched the Bioficial Organs Program, focused on developing functional human tissues and organs using a patient’s own cells. Central to this work is the use of advanced 3D bioprinting technologies for both therapeutic applications and in vitro drug testing. In 2020, Dr. Williams began collaborating with Orgenesis, Inc.

    Dr. Williams’ research spans medical devices and regenerative medicine, and he is credited with developing and patenting the first therapeutic methods using fat-derived stem and regenerative cells. He has authored more than 300 scientific publications and holds 30 issued U.S. patents, with numerous others pending. A serial entrepreneur, he has founded six biotechnology companies and has served in leadership and advisory roles across the medical device, regenerative medicine, and pharmaceutical industries.

    Dr. Williams is a Fellow of the American Heart Association and the American Institute of Medical and Biological Engineering, reflecting his enduring contributions to both science and clinical innovation.

/ – THE TECHNOLOGY

The Technology behind it

Discover the science and innovation driving our advanced solutions, designed to deliver safe, effective, and transformative results.

Revolutionary Approach to Liver Regeneration

LiverCell is focused exclusively on liver regeneration enabling a patient’s own regenerative stem cells and proteins to be used to regrow functioning livers within a patient’s own body instead of getting a donor transplant or an artificial liver. Our initial focus is helping patients with end stage liver disease (ESLD). We have patented and patent pending bioelectrical signaling sequences for these protein expressions for intended these purposes…

  • SDF1 + PDGF = stem cell homing for regeneration
  • Tropoelastin = stem cell proliferation and elasticity improvement
  • VEGF = blood vessel growth and liver regeneration
  • EGF+ HGF = liver regeneration
  • Klotho + Follistatin = liver regeneration
  • Sonic hedgehog = liver regeneration

Liver Anatomy

LC-15 Liver Regeneration Composition

For the most severe liver disease patients we plan to include repeat delivery of our LC-15 liver regeneration composition via a re-fillable micro pump. LC-15 composition includes the following:

  • Adipose tissue derived stem cells and stromal fraction
  • Selected growth factors such as Klotho, IGF1 and SDF1
  • Platelet Rich Fibrin
  • Regenerative fluid from amniotic sourcing
  • Selected exosomes
  • Micro RNA gel
  • Oxygenated nanoparticles
  • Nutrient hydrogel
  • Selected alkaloids
  • Liver matrix

LiverCell Technology & Devices

  • Leonhardt MicroStimulator II
  • Leonhardt Implantable Micro Stimulator Option

Instead of a donor liver treating one patient, LiverCell is designed to enable a patient to regenerate their own liver. Instead of major surgery, LiverCell uses a small endovascular infusion catheter with bioelectric stimulation leads built in connected to a small re-fillable infusion pump and bioelectric stimulator placed just under the skin which are designed to regenerate back to full function a patent’s own liver.

LiverCell Product

The Future: 100% Non-Invasive Therapy

THE FUTURE IS 100% NON-INVASIVE THERAPY FOR LIVER REGENERATION AND LIVERCELL PLANS TO LEAD THE WAY!

Instead of a using a minimally invasive infusion catheter and stimulation leads as we are in our first generation product our second generation LiverCell product is designed to regenerate livers with a 100% non-invasive approach. This is done getting our bioelectric signaling sequence signals to the right places to affect the right protein releases to enable liver regeneration without any invasive procedure required. The bioelectric signals will be delivered from outside of the patient’s body! Non-invasive bioelecdtric therapy has already demonstrated successful results in a number of studies for other organs including kidneys with success and our LiverCell team is adapting that core technology now for liver regeneration.

Liver image

Our Pipeline

  • LiverCell Endo-Bioelectric: Pre-clinical
  • LiverCell Endo-Bioelectric+Biologics: Pre-clinical
  • LiverCell Non-Invasive: Clinical studies expected to launch 2H 2019

/ ? — FAQ

Common questions

Don’t see your question? Reach out and our clinical team will respond personally.

The capability of the liver to fully regenerate after injury is a unique phenomenon essential for the maintenance of its important functions in the control of metabolism and xenobiotic detoxification.

Liver regeneration is the process by which the liver is able to replace lost liver tissue from growth from the remaining tissue. The liver is the only visceral organ that possesses the capacity to regenerate.[1][2] The liver can regenerate after either surgical removal or after chemical injury.[3] It is known that as little as 25% of the original liver mass can regenerate back to its full size.[2][4] The process of regeneration in mammals is mainly compensatory growth because only the mass of the liver is replaced, not the shape.[5]

Interleukin 6, IGF1, TNFa, VEGF, HGF, EGF, Klotho, Tropoelastin, eNOS Sonic Hedgehog, CXCL5, Neurogenin 3, Follistatin, FGF, WnT proteins, TGFb, Jagged, Delta and Notch proteins, Activins, BMPs, SDF1, PDGF, HIF1a.
TNFα and IL-6 are thought to play major roles in initiating the process of liver regeneration.

Liver regeneration is a highly organized tissue regrowth process and is the most important reaction of the liver to injury. The overall process of liver regeneration includes three phases: priming stage, proliferative phase, and termination phase. The initial step aims to induce hepatocytes to be sensitive to growth factors with the aid of some cytokines, including TNF-α and IL-6. The proliferation phase promotes hepatocytes to re-enter G1 with the stimulation of growth factors. While during the termination stage, hepatocytes will discontinue to proliferate to maintain normal liver mass and function. Except for cytokine- and growth factor-mediated pathways involved in regulating liver regeneration, new substances and technologies may emerge through further research to influence the regenerative process.

Using a direct conductive lead or nerve pathways a bioelectric stimulator delivers to the liver a series of bioelectric signaling sequences that home reparative stem cells to the liver, grow new blood supply, release regenerative proteins and differentiated stem cells into living functioning new liver tissue.

In addition to bioelectric stimulation therapy a re-fillable micro infusion pump is used (often with two chambers) to deliver slow infusions directly or nearly directly into the liver of the LC-15 fifteen component liver regeneration composition comprised of adipose tissue derived cells and stromal fraction, PRF, regenerative fluid derived from amniotic sourcing, micro RNA gel, selected growth factors, growth hormone, selected exosomes, oxygenated nanoparticles, nutrient hydrogel, selected alkaloids and liver matrix. The biologics therapy may be supplemented with patient specific liver cells harvested, cultured and multiple in a laboratory and re-injected into the patient via a re-fillable slow infusion micro pump.

Non-Invasive delivery of bioelectric signaling sequences and in severe cases IV infusion of the LC-15 cocktail composition for liver regeneration.

Home/recruit stem cells from a patient’s own bone marrow, fat tissue and circulating blood to their liver.

Klotho is a known anti-aging protein with powerful regeneration support capabilities is required for FGF19 binding to FGFR4, intracellular signaling, and downstream modulation of gene expression in regenerating livers.

Hedgehog signaling is critical for normal liver regeneration.

IGF-I is expressed in virtually every tissue of the body, but with much higher expression in the liver than in any other tissue. GH is a member of the cytokine superfamily of polypeptide regulators (13). The growth-promoting effects of GH can be direct in selected target tissues, such as liver, or indirectly, via its endocrine mediator IGF-I. GH is the primary regulator of IGF-I synthesis and secretion in hepatocytes; in turn, IGF-I regulates GH secretion IGF1 and GH play a major role in the process of liver regeneration. Recent studies have clarified the essential roles of GH and IGF-I in the liver. GH profoundly reduces visceral fat, which plays an important role in the development of NAFLD. Furthermore, GH directly reduces lipogenesis in the hepatocytes. IGF-I induces cellular senescence and inactivates hepatic stellate cells, therefore ameliorating fibrosis. IGF-I treatment has been shown to improve animal models of NASH and cirrhosis, suggesting potential clinical applications of IGF-I in these conditions.

Hepatocyte growth factor gene therapy accelerates regeneration in cirrhotic mouse livers after hepatectomy

Abstract

The effects of recombinant human hepatocyte growth factor (HGF) on liver growth and function of normal and partially hepatectomized rats have been examined. HGF was continuously administered into the jugular vein because it was rapidly eliminated from the plasma (t1/2 alpha; approximately 4.5 min) and degraded. In normal rats, the labeling index of hepatocytes was increased about 6 times by the administration of HGF. HGF also decreased the prothrombin time and increased the hepaplastin and serum albumin content. In 70%-hepatectomized rats, HGF stimulated liver regeneration and increased the level of blood proteins such as hepaplastin in a dose-dependent manner. The stimulation of serum protein level seemed to result from not only the increase of hepatic cell number but also the direct effect of HGF on the protein production in hepatocytes, because HGF rapidly enhanced the protein synthesis prior to the increase of cell number and increased the mRNA content of albumin in the liver in vivo. In addition, a combination of heparin with HGF further accelerated the effects of HGF described above, possibly due to the decrease of HGF clearance. These findings suggest that HGF accelerates both the hepatic regeneration and function in vivo, and that rhHGF is clinically expected to be a potent therapeutic agent in hepatectomy and liver injury.

Studies demonstrate that EGFR is a critical regulator of hepatocyte proliferation in the initial phases of liver regeneration.

Epidermal growth factor receptor restoration rescues the fatty liver regeneration in mice

Understanding Liver Regeneration – The American Journal of Pathology
Apr 16, 2018 – When Sonic hedgehog (Shh) binds to Patched (Ptch) receptor, … Hedgehog signaling is critical for normal liver regeneration after partial …

Liver Regeneration: Analysis of the Main Relevant Signaling Molecules
Aug 10, 2017 – Liver regeneration is a highly organized tissue regrowth process and is the most important reaction of the liver to injury. The overall process of …

Mesenchymal stem cells accelerate liver regeneration in acute liver failure animal model
Mesenchymal stem cells (MSCs) have a critical role in the regeneration of liver injury through regulating platelet-derived growth factor (PDGF) and vascular …

Clinical implications of advances in liver regeneration
Mar 25, 2015 – When the liver volume returns to its own size, activin A, apoptosis and other factors may terminate the regeneration process.14 Table 2 …

MicroRNAs in Liver Regeneration
Sep 8, 2015 – Liver maintains a unique tremendous regeneration capacity in response to … between miR-34a and activin-A in termination regenerating livers

Cellular Mechanisms of Liver Regeneration and Cell-Based Therapies of Liver Diseases
Dec 27, 2016 – Liver regeneration is activated spontaneously after injury and can …. Normal liver tissue contains relatively small amount of extracellular matrix …

The alterations in the extracellular matrix composition guide the repair of damaged liver tissue
Jun 6, 2016 – While the cellular mechanisms of liver regeneration have been thoroughly studied, the role of extracellular matrix (ECM) in liver regeneration is …

Nanoparticles for the treatment of liver fibrosis
Keywords: liver fibrosis, inorganic nanoparticles, liposomes, micelles … nodules of regeneratinghepatocytes defines cirrhosis, ie, the so-called advanced liver fibrosis. … in the production of acet-aldehyde and reactive oxygen species (ROS)…

Hydrogel nudges stem cells to grow into liver cells
Oct 8, 2018 – The new nanomaterial-based hydrogel, which gets certain stem … metabolism, immunity, and storage of nutrients within the body. … The research appears in the Journal of Tissue Engineering and Regenerative Medicine…

Development of hydrogels for regenerative engineering
May 1, 2018 – In addition, current hydrogel-based regenerative engineering strategies …. lung, liver, kidney, cartilage, bone, retina, trachea, and dermis using various …. scale to efficiently supply fluid and nutrients to the peripheral tissues…

Injectable hydrogels delivering therapeutic agents for disease treatment and tissue engineering
Sep 26, 2018 – In this article, recent studies of injectable hydrogel systems applicable … reaction, Disease and cancer therapy, Tissue repair and regeneration … permeability to oxygen and nutrient, physical properties similar to the ….. nerve, cornea, skin, bone, several organs including liver and kidney, dental, and so on.

3-D culturing hepatocytes on a liver-on-a-chip device
Jan 17, 2019 – Liver-on-a-chip cell culture devices are attractive biomimetic models in drug … across the hydrogel surface for steady nutrient media exchange, to and from the …. in drug toxicology, drug discovery and regenerative medicine.

Fibrin Hydrogels for Endothelialized Liver Tissue Engineering with a Predesigned Vascular Network
Sep 20, 2018 – Fibrin Hydrogels for Endothelialized Liver Tissue. Engineering with a … organ implantation, which provides nutrients and removes metabolites for multi-cellular tissues. … engineering and regenerative medicine. Numerous …

/ – KNOWLEDGE BASE

Related resources

Want to learn more? Browse our clinical resources and scientific publications on our comprehensive suite of targeted treatments.

Bioelectric Stimulation & Technology

This group focuses on the core bioelectric technology and hardware used to stimulate liver tissue and metabolic processes for regeneration.

Leonhardt Implantable Micro Stimulator Option

Technical specifications for the implantable device designed for targeted liver stimulation.

View details
tDCS Effects on Liver Lipid Accumulation

Research on how transcranial direct current stimulation can influence liver fat and inflammation.

View details
Transcutaneous Electrical Stimulation for Fatty Liver

A study examining how external muscle stimulation impacts experimental fatty liver conditions.

View details

Molecular Signaling & Growth Factors

These resources detail the specific proteins, cytokines, and signaling pathways (like VEGF, HGF, and SDF-1) that trigger liver cell regrowth.

Regulation of Liver Regeneration by Growth Factors

A comprehensive look at the cytokines and growth factors that control the liver’s healing process.

View details
Signals and Cells Involved in Regulating Liver Regeneration

Detailed analysis of the cellular signals required for effective organ recovery.

View details
HGF and SDF-1 Mediated Mobilization

Research on how these specific factors move stem cells to the liver after major surgery.

View details
Involvement of SDF-1 in Stem Cell-Aided Regeneration

Investigates the role of SDF-1 in guiding stem cells to damaged liver tissue.

View details
VEGF Importance in Early Liver Regeneration

Study showing how vascular growth factors are critical immediately following liver resection.

View details
VEGF and eNOS During Revascularization

Examines blood vessel formation and tissue regrowth in rat models.

View details
Follistatin for Accelerated Regeneration

A study on how a single dose of follistatin can speed up liver recovery.

View details
Activin vs. Follistatin in Massive Hepatectomy

Comparison of which protein better supports the liver after massive tissue loss.

View details
IGF-1R Knockout and Impaired Proliferation

Research showing how removing certain growth factor receptors halts liver healing.

View details
Main Relevant Signaling Molecules Analysis

A review of the primary molecules that drive the regeneration process.

View details
MicroRNAs in Liver Regeneration

Exploration of how small RNA molecules regulate gene expression during liver repair.

View details

Stem Cell Therapies & Cellular Mechanisms

Focused on the use of bone marrow and mesenchymal stem cells as a treatment modality for various liver diseases.

Bone Marrow Stem Cells and Liver Disease

Overview of how bone marrow-derived cells contribute to liver healing.

View details
MSCs Accelerate Liver Regeneration in Acute Failure

Evidence of mesenchymal stem cells speeding up recovery in animal models of liver failure.

View details
Cellular Mechanisms and Cell-Based Therapies

Analysis of the different types of cells used in modern regenerative medicine for the liver.

View details
Understanding Liver Regeneration (AJP)

Fundamental biological insights into how liver tissue repairs itself at a cellular level.

View details
Clinical Implications of Advances in Regeneration

How scientific breakthroughs are being translated into actual clinical treatments.

View details

Bio-Engineering, Hydrogels & Nanotechnology

Highlights the “scaffolding” and delivery systems—like hydrogels and nanoparticles—that support liver cell growth and matrix repair.

Hydrogels for Liver Cell Growth

Research on how hydrogel environments “nudge” stem cells to become functional liver cells.

View details
Injectable Hydrogels for Therapeutic Delivery

Details on using injectable gels to deliver drugs and cells directly to damaged tissue.

View details
Fibrin Hydrogels for Vascular Networks

Engineering liver tissue with pre-designed blood vessel systems.

View details
Development of Hydrogels for Regenerative Engineering

A broad look at the evolution of hydrogel technology in medicine.

View details
Nanoparticles for Liver Fibrosis Treatment

Using nanotechnology to target and treat scarring in the liver.

View details
Extracellular Matrix (ECM) Alterations

How the composition of the tissue surrounding cells guides liver repair.

View details
3-D Culturing on Liver-on-a-Chip

Advanced technology for growing liver cells in a controlled 3D environment.

View details

Fibrosis & Cirrhosis Resolution

Resources specifically addressing the reversal of permanent scarring (fibrosis) and the treatment of end-stage cirrhosis.

Reversibility of Liver Fibrosis

Scientific evidence that liver scarring can potentially be undone.

View details
HGF Promotes Resolution from Liver Cirrhosis

How Hepatocyte Growth Factor leads to the healing of cirrhotic tissue.

View details

CAUTION Disclaimer and Warning: Products described on this web site are in early stage development and are not yet proven safe or effective in statistically significant controlled clinical studies. Any statement or phrases implying efficacy or safety in any form are considered modified by “intended to” or “designed to”. Investigational use only in countries where investigation is permitted by law and proper filings have been made and appropriate regulatory clearances have been granted. Any use of the product(s) must be in an authorized clinical study with institutional review board (ethics committee) approval and proper patient consent procedures followed. For other countries product is only available for laboratory investigation by credentialed institutions and investigators with proper clearances with a research agreement in place with a study sponsor. NOT AVAILABLE FOR SALE.

Join the Future of Therapy

Start with a consultation.

Take the first step towards a future without donor transplants. Whether you are a patient seeking a revolutionary regenerative therapy or a clinical partner wanting to offer the latest bioelectric technology to your patients, our team is here to help you get started with LiverCell.

Book a Consultation