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American Academy of Stem Cell Physicians Visit Capitol Hill to Discuss Patient Safety

MIAMISept. 23, 2019 - The American Academy of Stem Cell Physicians visited Capitol Hill on Thursday, Sept. 19, at an event hosted by Alliance for Cell Therapy Now, to meet with industry partners to discuss the future and direction of cell therapy in the United States.  

A panel of industry experts came together to start a conversation with industry partners moderated by Janet Marchibroda, President of the Alliance for Cell Therapy Now. Among the panel were Dr. Peter Marks, MD, Ph.D., Director at the Center for Biologic Evaluation and Research at the FDA; Amy Patterson, MD, Chief Science Advisor and Director of Scientific Research Programs and Strategic Initiatives at the National Institutes of Health; Bernard Siegel, JD, Executive Director for the Regenerative Medicine Foundation; Anthony Atala, MD, Director at Wake Forest Institute for Regenerative Medicine and Professor at the Wake Forest University School of Medicine, and Joanne Kurtzberg, MD, Jerome Harris Distinguished Professor of Pediatrics; Professor of Pathology; Director of the Marcus Center for Cellular Cures; Director of the Pediatric Blood and Marrow Transplant; Director at the Carolinas Cord Blood Bank and Codirector at the Stem Cell Transplant Laboratory at Duke University Medical Center. 

The meeting started with opening remarks by the moderator, Janet Marchibroda, discussing the current industry practices and dangers facing cell therapies. Dr. Atala spoke next about the new approaches to healthcare and developing technologies in organ scaffolding utilizing autologous cells in the field of regenerative medicine. Dr. Kurtzberg went over several well designed current clinical trials being conducted under IND at Duke University involving children with autism and cerebral palsy using cell therapies. She discussed an impressive case study involving a child with cerebral palsy who had severely impaired motor function and required a walker. The patient was treated with autologous stem cells and a year later did not need assistance walking and saw a sharp decline in scissor walking. Bernard Siegel discussed how a handful of medical clinics have caused patient harm or made questionable claims, taking advantage of vulnerable patients and casting a negative light on the industry and his work at the Regenerative Medicine Foundation, a nonprofit organization dedicated to advancing regenerative medicine therapies. Dr. Patterson talked about the 21st Century Cures Act that was implemented using several provisions "to make safe and effective regenerative cellular therapies available to patients, including extending Food and Drug Administration (FDA) expedited programs to include regenerative therapies and providing funds for research through the National Institutes of Health (NIH)."

The Alliance for Cell Therapy Now is a coalition of organizations representing patients, health care providers, and the academic and scientific community, who are working together to advance safe and effective regenerative cell therapies. They support a document that builds upon the current provisions included in the 21st Century Cures Act:

- Development, consensus, and adoption of standards and best practices to support improvements in development, manufacturing, and delivery

- Launch of an outcome database-or registry-to measure outcomes, advance the science, drive improvements in manufacturing and delivery, and inform regulatory evaluation and payment, as well as clinical and patient decision-making

- Development of and support for workforce initiatives, including those in technical and community colleges, to build capacity and prepare the skilled, technical workforce for this emerging field

- Additional funding support for research at the NIH

- Increased capacity at the FDA to support both enforcement efforts and strategies to support academic and research institutions, as well as innovators, who need assistance in navigating FDA regulatory requirements

Expansion of the 21st Century Cures Act is necessary to effectively address the need for safe and effective cell therapy treatments for patients. Dr. Marks was the last to speak and he addressed the FDA's current stance on the emerging industry and how to effectively provide a pathway for manufacturers and physicians to safely treat their patients with cell therapies while adhering to agency regulations.

A spokesman for the AASCP, Dr. Farshchian, added; "the panel conveyed their message crystal clear; they are concerned about the safety of America, they are seeing an influx of poorly-qualified physicians making claims in hotel rooms. The American Academy's ethical committee has been notifying these substandard health care providers with guidance letters."


Visiting Capitol Hill to discuss Industry safety standards



The American Academy of Stem Cell Physicians (AASCP) is an organization created to advance research and the development of therapeutics in regenerative medicine, including diagnosis, treatment, and prevention of disease related to or occurring within the human body. Secondarily, the AASCP aims to serve as an educational resource for physicians, scientists, and the public in diseases that can be caused by physiological dysfunction that are ameliorable to medical treatment.

For further information, please contact Marie Barba at AASCP 305-891-4686.

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Visiting Capitol Hill to discuss Industry safety standards

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SOURCE The American Academy of Stem Cell Physicians

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