Howard Leonhardt to Present 25 Years of Experience Muscle Stem Cell Transplantation @ Los Angeles Cardiology Conference

Howard Leonhardt to Present 25 Years of Experience Muscle Stem Cell Transplantation @ Los Angeles Cardiology Conference

What we have learned and where do we go from here?

Los Angeles, CA, November 20th, 2013 /PRNewswire/ — Howard Leonhardt, founder of Bioheart, Inc. and Leonhardt Ventures and research scientist with 21 U.S. patents for treating cardiovacular disease will be presenting his team’s experience with muscle stem cell transplantation for heart failure treatment at 7:08pm November 20th, 2013 at Controversies and Advances in the Treatment of Cardiovascular Disease: The Thirteenth in the Series
Nov 20–22, 2013
The Beverly Hills Hotel
    Beverly Hills, California
Leonhardt’s presentation, titled “25 Years’ Experience With Muscle Stem Cell Transplantation” is listed as Oral Abstract #613 in the program 7:08pm pm Wednesday 11/20.

Earlier this week the Leonhardt Ventures’ Cal-X Stars Business Accelerator, Inc. announced a new $15 million private offering funding campaign to advance forward the below mentioned research under the new 506c JOBS ACT Title II regulations permitting up to 2000 shareholders – http://www.prnewswire.com/news-releases/leonhardt-ventures-cal-x-stars-business-accelerator-raising-15-million-232350001.html
Over the past 25 years, the team’s research and trials in stem cell transplantation for treating heart failure have revealed the following:
  • Embyronic stem cells do not work in myocardial scar tissue. They form fibroblasts or more scar. They die out.
  • Cardiomyocytes die out when injected in myocardial scar tissue (they require too much oxygen and nutrients) and cannot be multiplied to therapeutic dosages. They are electrically unstable in scar tissue.
  • Adipose, blood, bone marrow, placenta and embryonic stem cells cannot grow new muscle in scar tissue.
  • Cardiac stem cells only work to form new muscle on the rim edge of a scar, not in the center.
  • Only myoblasts or immature myoblasts have demonstrated an ability to form new contractile muscle in deep scar tissue in advanced heart failure patients.
  • Over 4,000 animal studies have been completed for muscle stem cell repair of damaged heart tissue since Dr. Race Kao’s and Dr. George Magovern’s original work in 1988 which was published in The PHYSIOLOGIST in 1989, with the nearly universal majority yielding positive results for myoblast transplantation.
  • More than 400 patients have been enrolled in clinical trials for myoblast transplantation since June of 2000.
  • Direct needle catheter injection into scar tissue is far superior to coronary infusion or other methods.
  • Targeted cell delivery is not needed. The cells naturally spread all over scar tissue if they are injected anywhere near the scar tissue and migrate to the injured tissue areas.
  • In clinical trials, 84% of myoblast-treated heart-failure patients have improved; only 16% worsened.
  • 69% of non-treated control or placebo patients in clinical trials have worsened.
  • 33% of myoblast-treated patients with only one injection session exhibited substantial improvement in cardiac function and/or quality of life or exercise capacity improving up to two full heart failure classes.
  • Myoblast-treated patients in Phase II/III controlled studies (randomized, double blinded, placebo controlled) improved 95.7 meters over placebo patients (-4 meters decline) in exercise capacity in clinical trials. No other stem cell type, drug or device has ever beat 53 meters improvement in a controlled trial; cardiac resynchronization therapy (CRT) pacers achieved an improvement of 20 meters, cardiac stem cells increased exercise capacity by 53 meters, allogeneic bone marrow cells 10 meters, while CHF drugs were associated with a 4-meter decline.
  • It is expected based on data available to date that repeat myoblast transplantation will reduce by half hospitalizations from heart failure. Heart-failure hospitalizations and associated care are the single leading drain on Medicare in the USA.  The leading cause of hospitalization in the USA for people over 60.
  • Myoblast-transplanted patients have a lower incidence of arrhythmias six months and one year after treatment than non-treated patients. Premature ventricular contraction (PVC) data demonstrates 0.05% for myoblast-treated patients and close to 3% for non-treated patients.
  • 33% of myoblast-treated patients improve two heart failure classes.
  • 33% of myoblast-treated patients have greater than 15% improvement in left ventricular ejection fraction (LVEF) via dobutamine stress echo studies.
  • Pressure-volume (PV) loop studies have demonstrated myoblast-treated patients have substantial positive reverse re-modeling.
  • Close to $300 million has been spent to date on myoblast transplantation for heart failure research since 1988.  Bioheart, Inc. has invested over $100 million to advancing this development.
  • Pre-treating scar with microRNAs, stromal cell-derived factor-1 (SDF-1) and nutrient hydrogel before cell transplantation can improve results.
  • Genetically modifying cells to over-express SDF-1 can double improvement results and the consistency of results. Myoblasts alone lead to 27% improvement, while SDF-1 myoblasts result in 54% improvement. 66% of test subjects received substantial new muscle formation with SDF-1 myoblasts compared to 33% with ordinary myoblasts.
  • New muscle formed with myoblasts is stretch-activated.
  • Injecting cardiac stem cells or induced pluripotent stem (iPS) cells at the rim edge of scar and myoblasts in the center of scar in combination may be worth studying.
  • Electrical stimulation before, during and after stem-cell transplantation can dramatically improve results.
  • Nutrient hydrogel can help improve myoblast cell engraftment in scar tissue.
  • Repeat injection sessions can dramatically improve results – Bioheart sponsored study F. Prosper et. al. was published in the European Heart Journal – another similar confirming pre-clinical study was published in Japan.
  • Stem cell pumps are being developed to deliver cells and growth factors over time.
  • Wireless energy devices for directing stem cell therapies non-invasively are being developed.
  • For more information on the 13th Annual Controversies and Advances in the Treatment of Cardiovascular Disease visit – http://promedicacme.com/meeting/Controversies-and-Advances-in-the-96.html  To learn more about advances in regenerative medicine, visit http://www.bioheartinc.comwww.calxstars.com ;and http://www.leonhardtventures.com.
About Leonhardt Ventures: Since 1982 Leonhardt Ventures http://www.leonhardtventures.com has a strong history of inventing, developing, backing and bringing to market leadership products for treating heart and cardiovascular disease. Over 200,000 patients have been treated to date with Leonhardt inventions. In the 1980s, the group developed market leadership in patented polyurethane balloon catheters including drug, stem cell and radiation delivery systems. In the 1990s, they developed over 20 additional devices including the first commercially successful stent graft for aortic aneurysm repair (TALENT – Taheri-Leonhardt Stent Graft). The team completed the first ever truly percutaneous repair of an aortic aneurysm without surgery in Melbourne, Australia, in 1995, and published the first paper on thoracic aortic dissection repair with stent grafts in The New England Journal of Medicine in 1999. Other firsts for the team include the first conformance-sealing stent graft, the first above renal fixation stent graft, the first customized-to-fit individual patient stent grafts, the first multi-stage low-profile stent graft, the first removable stent graft, the first foam and bioglue sealing cuff for stent grafts, and the first use of muscle stem cells to reinforce aortic wall necks after stent graft placement. The team developed and patented the first percutaneous heart valve, intravascular lung catheter, the Pro-Cell intracavity stem cell delivery system and the MyoCath line of stem cell delivery catheters. Leonhardt-patented inventions include the first heart failure pacemaker able to recruit repairative stem cells to damaged heart tissue (MyoStim Pacers www.myostimpacers.com). In 2001, the team led the world’s first non-surgical case of muscle stem cell repair of damaged heart muscle in a human patient with Bioheart MyoCell. That led to the first Phase III double-blinded, randomized, placebo-controlled trial for stem cells growing new contractile muscle in post-heart-attack tissue in advanced heart failure patients, with results published in the American Heart Journal: Bioheart MyoCell resulted in 95.7 meters improvement in exercise capacity over placebo (minus 4 meters decline). The team is preparing to complete the first-ever biological pacemaker implantation in a human patient within the next 12 months (BioPace)
About Bioheart, Inc.
Bioheart is focused on completing its Phase II/III MIRROR study for MyoCell in treating advanced heart failure. The product candidate has been in clinical trials since May 2001. The company believes, after 10 years of clinical trials that followed pre-clinical studies dating to 1988, that it may be on the final leg toward qualifying to apply for a biologics license-approval FDA panel review. Approximately 130 more patients are needed in the randomized, double-blinded, placebo-controlled MARVEL Phase II/III Part II study. MyoCell is a clinical muscle-derived stem cell therapy designed to populate regions of scar tissue within a patient’s heart with new living cells for the intended purpose of improving cardiac function and quality of life in chronic heart failure patients.
For more information on Bioheart, visit http://www.bioheartinc.com.
Forward-Looking Statements: Except for historical matters contained herein, statements made in this press release are forward-looking statements. Without limiting the generality of the foregoing, words such as “may,” “will,” “to,” “plan,” “expect,” “believe,” “anticipate,” “intend,” “could,” “would,” “estimate,” or “continue” or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements.
Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Also, forward-looking statements represent our management’s beliefs and assumptions only as of the date hereof. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.
The Company is subject to the risks and uncertainties described in its filings with the Securities and Exchange Commission, including the section entitled “Risk Factors” in its Annual Report on Form 10-K for the year ended December 31, 2012, and its Quarterly Reports on Form 10-Qs.
Media Contact:
Howard Leonhardt, Leonhardt Ventures, 1531 6th Street, Unit 401, Santa Monica, California, 90401, 310 310 2534, email: hleonhardt@aol.com
SOURCE Leonhardt Ventures
SOURCE Bioheart, Inc.
Controversies and Advancement in the
Treatment of Cardiovascular Disease
The Thirteenth in the Series
November 20-22, 2013 ¨ The Beverly Hills Hotel
Wednesday, November 20, 2013 – Beverly Hills Hotel, Los Angeles, CA
 
6:00 – 8:00 PM                        Moderated Oral Abstract Session
                                                Moderators: Wen Cheng, MD, and Mamoo Nakamura, MD
6:00 – 6:08 PM            #593Percutaneous Transcatheter Transapical Access for Prosthetic Mitral Paravalvular Leak Closure
                                                Wen-Loong Yeow, MD
6:08 – 6:12 PM                        Discussion
6:12 – 6:20 PM            #601: Three Dimensional Computed Tomography Assessments of Iliofemoral Vasculature for Transfemoral Transcatheter Aortic Valve Replacement
                                                Kazuaki Okuyama, MD
6:12 – 6:16 PM                        Discussion
6:16 – 6:24 PM            #603: Percutaneous Paravalvular Leak Closure for Transcatheter Aortic Valve Replacement
                                                Kazuaki Okuyama, MD
6:24 – 6:28 PM                        Discussion
6:28 – 6:36 PM            #606: The Effects of Prior Sternotomy on Mortality and Morbidity After Adult Heart-Only Transplantation
6:36 – 6:40 PM                        Morcos Awad, BS
6:40 – 6:48 PM            #607: Combined Heart-Liver Transplantation: Clinical Outcomes and Insights
                                                Heidi Reich, MD
6:48 – 6:52 PM            Discussion
6:52 – 7:00 PM            #612: Therapeutic Efficacy of Cardiosphere-Derived Cells in a Transgenic Mouse Model of Nonischemic Dilated Cardiomyopathy
                                                Eduardo Marbán, MD, PhD
7:00 – 7:08 PM            Discussion
7:08 – 7:16 PM            #613: 25 Year Experience Muscle Stem Cell Treatment Heart Failure
                                                Howard Leonhardt
7:16 – 7:20 PM            Discussion

RELATED LINKS
http://www.bioheartinc.com

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