Perinatal Stem Cell Society 2020 Meetings
The 2020 annual congress of the International Perinatal Stem Cell Society is coming up March 4-6 in Salt Lake City, Utah. The topics covered in this meeting straddle the edge between what is proven in clinical trials, versus what is actually practiced in clinics, and some of the content may be considered controversial.
Many companies and clinics in the perinatal industry operate as if they qualify under the FDA’s 361 regulations, when a closer examination of their claims and practices may show that they really are producing 351 products that should be regulated as drugs. The FDA has given these companies a grace period to become compliant with 351 regulations that ends in November 2020.
The Perinatal Society annual congress includes a session that is dedicated to the regulatory landscape for perinatal products. There will be a panel discussion with experts in regulatory affairs, to address some of the burning questions in this field:
- Recently, the FDA has been issuing 20 warning letters per month regarding stem cell products. How will the FDA escalate come November 2020?
- Does the FDA have the manpower and the will to shut down over 650 clinics working in this space?
- Will the FDA take into account the safety record of the majority of perinatal tissue allografts that have been distributed for human therapeutic treatments in the United States?
- How will patient populations feel if they lose easy access to perinatal tissue allografts? Will they go offshore to completely unlicensed clinics?
The annual congress will also highlight the advancements made over the past year with cells from perinatal sources. There will be presentations from three clinics that have each applied perinatal stem cells to treat hundreds of children impacted by neurologic disorders: Dr. Joanne Kurtzberg from Duke University, Dr. Neil Riordan from the Panama Stem Cell Institute, and Dr. Tomasz Baran from Famicord in Poland. There will even be a testimonial from a mom turned patient advocate who will describe how cells from cord tissue changed her son’s life.
Scientific sessions at the congress will include updates from clinical trials using perinatal cells or exosomes, discussion of the comparative efficacy of different cell types, and discussions of optimum methods to manufacture and deliver cell therapy. Practicing orthopedic doctors will tell us why they do or don’t use perinatal products in the clinic. Cutting edge presentations will explore the ability to deliver therapy with exosomes.