October 15th, 2014 · Leave a Comment
Since 2007, Mayo Clinic and Cardio3 BioSciences, a biotechnology company based in Mont-Saint-Guibert, Belgium, have collaborated to advance our knowledge of disease in order to provide new solutions for patients and innovative delivery of quality care in the area of cardiac regeneration. Cardiac regenerative medicine uses reparative tools to restore damaged tissue and restitute function caused by heart disease.
Cardio3 BioSciences has successfully developed Mayo Clinic innovation leading to completion of a phase II trial on cardiopoetic stem cells in patients with heart failure. The Food and Drug Administration (FDA) has recently cleared the way for the Belgian company and Mayo Clinic to launch a phase III clinical trial of its stem cell therapy based on Mayo Clinic regenerative medicine research later this year.
Clinical application of regenerative biologics has emerged as a next generation tool that can be tailored to augment existing therapeutic strategies for otherwise incurable diseases, including heart failure. By leveraging research collaborations, such as with Cardio3 BioSciences, Mayo Clinic is positioned to transform the way we treat patients with heart disease.
In collaboration with Cardio3 BioSciences, Mayo Clinic researchers have discovered a novel way to repair a damaged heart by regenerating heart tissue.
In Mayo Clinic's breakthrough process, stem cells are harvested from a patient's bone marrow. The stem cells undergo a laboratory treatment that guides them into becoming cardiac cells. The treated cells are then injected into the patient's heart in an effort to grow healthy heart tissue.
“In regenerative medicine, the step between lab tests and clinical trials is a big one and the interaction with Cardio3 is crucial to driving Mayo Clinic's technology forward," says Atta Behfar, M.D., Ph.D., who spent several months in Belgium working with Cardio3 BioSciences. Dr. Behfar, a heart failure and transplant specialist, leads the Cardiac Program in the Mayo Clinic Center for Regenerative Medicine.
In late 2013, Mayo Clinic researchers and Cardio3 BioSciences developed a specialized catheter for transplanting stem cells into the beating heart. The novel cardiac catheter is able to dramatically improve stem cell retention in the heart. The device includes a curved needle and graded openings along the needle shaft, allowing for increased distribution of cells. The result is maximized retention of stem cells to repair the heart. The findings appear in the journal Circulation: Cardiovascular Interventions.
This new catheter is being used in the European CHART-1 clinical trials, now underway. This is the first Phase III trial to regenerate hearts of patients who have suffered heart attack damage. The studies are the outcome of years of basic science research at Mayo Clinic and earlier clinical studies with Cardio3 BioSciences and Cardiovascular Centre in Aalst, Belgium.
Preferred Access Agreement
Most recently, Mayo Clinic and Cardio3 BioSciences entered into an extended collaboration agreement. It builds on a long established and productive relationship of licensing and research in the area of cardiac regeneration. The mutual hope for this work is that together Mayo and Cardio3 BioSciences can accelerate Mayo discoveries toward clinical application.
Under the Preferred Access Agreement, the parties have agreed to regular periodic meetings to review Mayo’s regenerative medicine portfolio to identify areas and projects of mutual interest. The results of these conversations could potentially lead to cooperative research projects, license agreements or introductions to third parties to further the technology.
“We are excited for the opportunity to expand our collaboration with Cardio 3 and accelerate the delivery of novel therapies to patients”, says Clark Otley, M.D., Medical Director of Mayo Clinic Ventures which works to commercialize Mayo Clinic technologies for the benefit of patients worldwide.
The Center for Regenerative Medicine continues to explore strategic relationships with academic, biotechnology/industry, government and professional associations at the local, regional, national and international level.
October 13th, 2014 · Leave a Comment
“Feel the Beat” is an annual event that highlights Mayo Clinic’s commitment to transforming the practice of congenital heart disease with innovative regenerative strategies to prevent heart failure due to structural heart disease. This event brings together physicians, scientist, and children and families affected by severe heart defects, such as Hypoplastic Left Heart Syndrome (HLHS).
The Todd and Karen Wanek Family Program for HLHS is honored to host this event with some notable guests this year. Team members will showcase the latest research, guest speakers will share inspiring stories, and the congenital heart disease community will come together.
September 19th, 2014 · Leave a Comment
The Mayo Clinic Center for Regenerative Medicine and colleagues at the National University Ireland (NUI) Galway have signed a formal memorandum of understanding (MOU) to pave the way for joint clinical trials using regenerative therapies.
The MOU follows years of close collaboration with NUI Galway’s Regenerative Medicine Institute (REMEDI) and the Network of Excellence for Functional Biomaterials (NFB) and will focus on adult stem cell therapy, gene therapy, biomaterials and biomedical engineering. Furthermore, the agreement facilitates ongoing student and staff exchange between Galway and the United States.
Anthony Windebank, M.D., deputy director for Discovery, Mayo Clinic Center for Regenerative Medicine, and Professor Timothy O’Brien, director of the REMEDI, were among those present at the signing in Galway.
“Both the National University Ireland Galway and the Mayo Clinic Center for Regenerative Medicine have laboratories which are compliant with current good manufacturing practice (GMP) regulations as it applies to cell manufacturing,” says Professor O’Brien. “This allows us to initiate joint trials of regenerative therapies that will produce identical cell products.”
The U.S. Food and Drug Administration and the European Medicines Agency are making efforts to streamline and facilitate introduction of new therapies on both sides of the Atlantic Ocean. Carrying out these approval processes and completing joint studies will facilitate more rapid introduction of new therapies for patients.
“There have been many developments in stem cell technologies over the years, and we are getting to the point of bringing this new knowledge and technology to the patients,” adds Dr. Windebank. “This is a unique collaboration which emphasizes the translation of laboratory discoveries into regenerative medicine therapies for patients.”
Welcoming the agreement, Andre Terzic, M.D., Ph.D., says, “Mayo Clinic has prioritized the development of regenerative medicine clinical applications as a critical strategy for meeting the future needs of patients. Sharing experience through international collaborations fosters advances in this emerging field of science and medicine” Dr. Andre Terzic is the Michael S. and Mary Sue Shannon Family Director, Center for Regenerative Medicine, and Marriott Family Professor of Cardiovascular Diseases Research at Mayo Clinic.
The signing comes on top of the recent announcement of a new $16 million agreement between Mayo Clinic and Enterprise Ireland to advance novel medical technologies originating from Mayo Clinic with the aim of creating several high-value medical technology spin-off companies.
August 21st, 2014 · Leave a Comment
The second annual “HLHS Feel the Beat” will be held Saturday, November 8 at Mayo Clinic in Rochester, MInn. “HLHS Feel the Beat” is a fun-filled family event built around science, advocacy, families and patients. The Todd and Karen Wanek Family Program for HLHS will share the research being conducted that is changing the future for those affected by HLHS.
More information on the event is available on the HLHS Cause to Cure blog.
To learn more about HLHS research, visit the Center for Regenerative Medicine website.
July 30th, 2014 · Leave a Comment
Imagine a future in which a new lung is grown for a patient in need, using the patient’s own cellular material, or a day when an injection of replacement cells will enable a patient to self-heal damage in the brain, nerves or other tissues.
Regenerative medicine is no longer science fiction, and a substantial gift from Jorge and Leslie Bacardi of the Bahamas will significantly accelerate the research of Mayo Clinic’s Center for Regenerative Medicine on the Florida campus.
Jorge Bacardi, whose family has manufactured rum and other spirits for 150 years, suffered since childhood with primary ciliary dyskinesia, a debilitating lung disease that nearly ended his life. A double lung transplant at Mayo’s Florida campus in 2008 enabled him to take his first full breath of air at age 64.
“Regenerative medicine is an extraordinary step in the evolution of mankind,” says Jorge Bacardi. “It is for Leslie and I a great honor to be able to join Mayo Clinic in the development of such an advancement in the medical field."
Mayo’s regenerative medicine researchers are targeting conditions throughout the body, including heart disease, stroke, Alzheimer’s disease and traumatic injuries that affect combat veterans. Some studies are in the earliest stages. Others are in clinical trials with patients.
Researchers now can differentiate stem cells into skin, brain, lung and many other types of cells. For example, a patient's own skin cells may be collected, reprogrammed in a laboratory to give them certain characteristics, and then delivered back to the patient to treat diseases at various places within the body.
Leslie Bacardi says the couple was amazed by a segment on ABC’s “Nightline,” a late-night television news program, which showed beating heart tissue that Mayo Clinic researchers had developed from the skin tissue of one of the program’s reporters.
“That, to us, was just mind-boggling,” Leslie Bacardi says. “We really sincerely think that’s the future, and Mayo Clinic will make it happen. Think about a patient with Lou Gehrig’s disease, or diabetes. Are we going to get rid of that disease for them? I hope so."
“Regenerative medicine is for us an investment in our future and the future of medicine. It may take a while to reap any benefits but when those benefits do come, it will make the investment seem small. The excitement with which we look forward to the advancement of regenerative medicine will keep us hopeful for solutions to many medical mysteries.”
The Bacardis’ gift will establish the Jorge and Leslie Bacardi Fund in Regenerative Medicine honoring Cesar A. Keller, M.D., the physician who provided care to Jorge Bacardi before and after his double lung transplant and who is currently involved in regenerative medicine lung research.
Their gift also will be used to accelerate regenerative medicine work on the Mayo Clinic Florida campus, and will establish the Jorge and Leslie Bacardi Associate Director for the Center of Regenerative Medicine in Florida, a position currently held by Thomas A. Gonwa, M.D.
“We are very grateful for the Bacardis’ gift, which will greatly accelerate our ability to provide regenerative medicine solutions to patients,” says Dr. Gonwa, who is also chair of the Department of Transplantation atMayo Clinic in Florida. “The Bacardis’ generosity will help us transform medical care for people with some of the most difficult-to-treat conditions.”
The Bacardis’ latest gift builds upon their generosity. They, with other family members, made the lead gift to build the Gabriel House of Care on Mayo Clinic's campus in Jacksonville, Florida, to provide affordable, long-term housing and a supportive environment for visiting transplant and radiation oncology patients.The name honors Christopher Mark Gregory, who lost his life at age 19, and whose gift of organ donation enabled Jorge Bacardi to receive his transplant. Before Jorge Bacardi knew his organ donor by name, he wrote a heartfelt letter of gratitude to the donor family in which he referred to Christopher Gregory as "Gabriel," his saving angel.