Stem cells applications are expanding at an accelerating rate, with a search of the world’s largest clinical trial database (ClinicalTrials.gov) revealing that at least 7,797 trials now involve stem cell products or their derivatives. As the world’s largest database of clinical trials, this figure likely contains approximately three-quarters of clinical trials worldwide ― making the total count even higher.
In addition to stem cell products, a growing market has evolved for a diverse range of regenerative medicine products, including cellular therapies, immunotherapies, exosome therapies, biomaterials, tissue engineered products (TEPs), biologics, and more.
Furthermore, accelerated pathways for regenerative therapies have been introduced in leading nations worldwide, including the U.S., Japan, and South Korea. Legislation took effect in Japan in late 2014, in South Korea in 2016, and in the U.S. 2017. The EU has a program for product acceleration – the Adaptive Pathways.
Meanwhile, the U.S. FDA has continued to issue RMAT designations to a growing number of advanced therapies worldwide. At the time of this writing, the U.S. FDA states it has received 139 RMAT requests and issued 48.
Safety Panel on Regenerative Medicine in Clinical Practice
Given the rapid rise of regenerative medicine (RM), a highly anticipated Safety Standards Panel will be hosted by the American Academy of Stem Cell Physicians (AASCP) on August 1, 2020. The panel will occur as part of the AASCP’s upcoming Virtual Congress being hosted August 1-2, 2020.
In recent months, the AASCP has created guidelines which are safety recommendations for Physicians who are using stem cells and biologics within their medical practice.
Importantly, the upcoming Safety Standards Panel Discussion will include representatives from the U.S. FDA, as well as renowned leaders from across the RM field.
The AASCP’s upcoming Safety Panel will:
- Incorporate insights from the FDA on how to comply with existing legal and regulatory standards
- Discuss safety precautions and guidelines required for the safety of patients
- Address safety guidelines that are outdated and need revision to meet the demands of new cutting-edge medicines
- Explore insights from prominent leaders within regenerative medicine
On a practical level, the Safety Panel will discuss the clinical utilization of a wide range of regenerative materials, including but not limited to: stromal vascular fraction (SVF), bone marrow (BM), umbilical cord blood (UCB) and umbilical cord tissue (UCT), amniotic fluid, placental tissues, exosomes, peptides, xenografts, and allografts.
AASCP’s Virtual Congress & Safety Panel (Aug 1-2, 2020)
In addition to the Safety Panel, the AASCP will be offering its Board Exam for the third time. This year, it will be open to international student thanks to Zoom video conferencing.
Practice questions for the exam can be accessed here: https://www.aascp.net/board-
Importantly, the AASCP’s Virtual Congress will include didactic sessions, live patient demos, interactive workshops and a customized curriculum focusing on developing hands-on skills. While COVID-19 has caused many events to be rescheduled, this highly anticipated meeting is back by popular demand.
As the AASCP’s first Virtual Congress, the event will allow for wide-scale participation at an unprecedented scale. The Academy is expecting an unprecedented attendance of 5,000 attendees, with the program broadcasting internationally.
As shared by the spokesman for the AASCP, Dr. AJ Farshchian:
“The American Academy of Stem Cell Physicians is a group of physicians, scientists and researchers who collectively represent the most authoritative non-federal group advocating for guidelines and education on stem cell therapy and regenerative medicine. We are a nationally recognized academy with a mission to bring like-minded physicians together to increase awareness and education in the field of regenerative medicine. A defining characteristic of the AASCP is its commitment to ongoing education and awareness.”
The event will offer 8 CME credits to participants, allowing physicians to continue their medical education during this unusual time when many live events have been cancelled.
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