The KidneyCell II Clinical Trial will feature non-invasive bioelectric stimulation controlled release of the Klotho protein known to be beneficial in kidney health
- Topline Data Expected in 4Q 2020
Irvine, CA and Porto Allegre, Brazil – February 17th, 2020 (PRDistribution) — KidneyCell LTP www.kidney-cell.com, a formative stage startup company and Licensable Technology Platform (LTP), within the Leonhardt’s Launchpads by Cal-X Stars Business Accelerator, Inc. innovation and startup launch accelerator www.leonhardtventures.com announced today the launch of a clinical trial in Brazil utilizing bioelectric signaling controlled protein release to attempt to reverse kidney failure. The bioelectric stimulation signals will be applied non-invasively only in this study.
“We are excited to collaborate with KidneyCell LTP and Leonhardt’s Launchpads in opening this new clinical study with the exciting new technology of bioelectric controlled protein expressions, especially Klotho, and look forward to the recruitment of eligible patients for the KidneyCell II Trial in Brazil starting this week,” said Dr. Rodrigo Plentz Principal Investigator, Santa Casa de Misericordia Hospital Porto Allegre – Chief of Physicotherapy Service and Director of Research Program.
Dr. Leslie Miller, Chief Medical Officer of KidneyCell LTP and Leonhardt’s Launchpads commented “There is a great unmet medical need for kidney recovery and this non-invasive study may be a start towards meeting that need”. Dr. Miller is a cardiologist with over 241 peer reviewed publications and experience with over 80 clinical trials. He is co-editor of one of the leading textbooks on cardiovascular regenerative medicine. He formerly served for over a decade as the Chairman of Cardiovascular Medicine at the University of Minnesota.
Phil Patton, President of KidneyCell added “A better option for helping kidney failure patients recover is a grand goal that our team is highly committed to achieve. This will be the first ever study applying bioelectric controlled klotho protein release to attempt to reverse kidney failure that we hope will be a historic pioneering landmark towards helping the millions of patients in great need.”
For more serious kidney failure patients the KidneyCell LTP team has developed KidneyCell Plus which combines a micro implantable bioelectric stimulator with an implantable re-fillable micro infusion pump with infusion and electrical stimulation catheters directed to the kidneys. The under the skin micro infusion pump will be re-filled daily via a silicone septum with the KC-15 kidney regeneration composition comprised of stem cells and support factors (more information is below and on our web site).
The Plentz research team in Brazil previously published a positive clinical study utilizing electrical stimulation to reduce DNA damage associated with kidney failure – https://www.ncbi.nlm.nih.gov/pubmed/29529880
“Our clinical study support team in Brazil is prepared to take all steps to ensure this study is conducted at the highest standards of quality, good clinical practice and data integrity always putting patient safety first” stated Dr. Cristiane Carboni local Research Coordinator of the study.
“We have built into this study protocol a comprehensive lineup of tests that will be scientifically sound in establishing whether the candidate therapy is safe or effective for kidney recovery” stated Dr. Samer Bahihani Chief Nephrology Advisory to KidneyCell LTP and participant in the study design. Dr. Banihani is a Board Certified (Board of Internal Medicine Certification in Internal Medicine and American Board of Nephrology) Nephrologist helping to lead the kidney treatment programs at Providence Sacred Heart Medical Center and Children’s Hospitals in Spokane, Washington.
Leonhardt’s Launchpads is also co-sponsoring studies for bioelectric treatment of bladder dysfunction, erectile dysfunction, stroke recovery, knee joint recovery, mis-aligned teeth, blood pressure, internal inflammation, breast tissue loss and hearing regeneration at various clinics across Brazil supported by Leonhardt’s Launchpads Brazil. The Leonhardt team has a long history in Brazil dating back to the late 1980’s and early 1990’s where and when they launched research programs for non-surgical aortic aneurysm repair and heart valve replacement. Starting in 2000 the Leonhardt team worked in Brazil with local researchers, including Dr. Hans Dohmann, still a current advisor to the company, in developing muscle stem cell therapies for heart regeneration.
About KidneyCell LTP
KidneyCell LTP www.kidney-cell.com is a Licensable Technology Platform (LTP) and startup in formative stages within the Leonhardt’s Launchpads by Cal-X Stars Business Accelerator, Inc. which is focused on applying bioelectric signaling controlled regenerative protein expressions to revive failing kidneys. For severe cases the team has developed KidneyCell Plus which includes a re-fillable implantable and programmable micro infusion pump with a pacing infusion catheter directed to the kidneys that is re-filled daily with the KC-15 fifteen component kidney regeneration composition comprised of hypoxia treated stem cells, stromal fraction, adipose derived stem cells, selected exosomes, selected growth factors such as Klotho, micro RNA gel, PRF, amniotic fluid, selected alkaloids, oxygenated nano-particles, nutrient hydrogel and kidney matrix. Bioelectric signaling controlled protein expressions include SDF-1 and PDGF for stem cell homing and klotho, IGF1, HIF1a, sonic hedge hog, tropoelastin, HGF, EGF and other regeneration promoting proteins.
About Leonhardt’s Launchpads
Leonhardt’s Launchpads by Cal-X Stars Business Accelerator, Inc. formed in 2013 is an innovation and startup launch accelerator focused on organ regeneration and recovery utilizing bioelectrics and biologics. 30 startups and innovations are in the 2020 accelerator portfolio class https://leonhardtventures.com/development-pipeline/. Over 800 patients have been enrolled in clinical studies to date across all organs. The accelerator and its startups have over 600 issued, pending, optioned or licensed patent claims related to organ regeneration and recovery. 16 products are at clinical stage of development and 14 are at pre-clinical stage. Leonhardt’s Launchpads operates two research laboratories in the Los Angeles metro area and two in Salt Lake City, Utah and has close connections with a number of external prototyping houses and qualified vendors. Our bench top bioelectric stimulators and electrodes sourced from Mettler Electronics in Anaheim, CA have FDA 510K market clearance for improving blood circulation and pain relief.
About Leonhardt’s Launchpads Brazil
Leonhardt’s Launchpads Brazil headquartered in Porto Allegre, Brazil was formed in 2019 to provide local pre-clinical and clinical research support services to the full portfolio of Leonhardt’s Launchpads startup and innovations within Brazil.
About Leonhardt Ventures
Leonhardt Ventures (Leonhardt Vineyards LLC DBA Leonhardt Ventures) formed in 2005 as an LLC is the continuation of the H.J. Leonhardt & Co. sole proprietorship that began working on medical device inventions in 1982. Over 500,000 patients have been treated with Leonhardt inventions to date. Howard J. Leonhardt founder has over 22 issued U.S. patents related to organ regeneration and recovery and has hundreds of new patent claims pending with the USPTO. In the 1980’s the Leonhardt team developed world leadership in predictably complaint cardiovascular balloon catheters with the patented PolyCathTM product. In the 1990’s they developed multiple breakthrough innovations including the world’s leading system for repairing aortic aneurysms without surgery, the TALENT endovascular stent graft, and one of the first percutaneous heart valves. In 2001 Leonhardt led a team that completed the historic landmark first ever non-surgical repair of a human heart with muscle derived cells and went on to complete pilot, Phase I, Phase II and Phase II/II clinical studies at over 38 leading heart failure centers worldwide signed aboard with most (33 MARVEL STUDY) in the USA. Leonhardt founded Leonhardt’s Launchpads in 2009 in Santa Rosa, California to accelerate his organ regeneration focused inventions through first in human studies intended to be sufficient to induce a strategic partnership to take the commercialization efforts organ by organ further. In 2012 the headquarters was moved to the Los Angeles area (Irvine now) and in late 2015 a subsidiary was opened up in Salt Lake City, Utah. The accelerator has satellite locations in Northern California, Minneapolis, Pittsburgh, Australia and Brazil.
About Dr. Rodrigo Plentz
Rodrigo Della Méa Plentz is a Professor at the Universidade Federal de Ciências da Saúde de Porto Alegre and Chief of the Physiotherapy Serviceand Research at the Santa Casa de Misericórdia Hospital in Porto Alegre.He serves as an Advisor for Master’s and Doctorate Students in the Health Sciences and Rehabilitation Sciences Graduate Programs with over 100 peer reviewed publications and experience with over 50 clinical trials. Prof. Dr. Rodrigo Della Méa Plentz, Universidade Federal de Ciências da Saúde de Porto Alegre Rua Sarmento Leite, 245 – Porto Alegre, Rio Grande do Sul, Brazil – CEP 90050-170
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to KidneyCell’s expectations regarding the KidneyCell II Clinical Trial and KidneyCell LTP’s (Licensable Technology Platform within innovation and startup launch accelerator Cal-X Stars Business Accelerator, Inc. DBA Leonhardt’s Launchpads) other development plans. KidneyCell LTP has attempted to identify forward-looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey uncertainty of future events or outcomes. Although KidneyCell LTP believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including KidneyCell LTP’s ability to continue as a going concern, the need for additional financing, the success and timing of KidneyCell LTP’s clinical trials and regulatory approval of protocols, our collaborations, and those discussed under the heading “Risk Factors” in Leonhard’s Launchpads by Cal-X Stars Business Accelerator, Inc. most recent Annual Report and Private Placement Memorandum. Any forward-looking statements contained in this release speak only as of its date. KidneyCell LTP and Leonhardt’s Launchpads by Cal-X Stars Business Accelerator, Inc. undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
Additional Warnings and Disclaimers:
Patents pending may not be issued. Patents licensed may not be maintained. Product may be found to be infringing other patents. Timelines may significantly differ from goals even by many years. Budget funding require may be very much higher than projected. Product has NOT been proven to be safe or effective. As an investment investing in the accelerator or any of its early stage startups or un-proven innovations has to be regarded in the highest risk category for total loss. Although a best attempt is made to make sure all information provided is accurate and timely any Information provided in this press release and on all associated web sites is subject to potential inaccuracies including being out of date and is subject to change without notice. Startups and innovation developments mentioned are under staffed and under funded to reach their goals at this time. Although it is the goal of the accelerator to seek a strategic partnership after first in human results this may not be achieved.
Phil Patton, President
Howard J. Leonhardt, Executive Chairman & CEO
Dr. Leslie Miller Chief Medical Officer