The International Perinatal Stem Cell Society has released a position paper advocating for changes to the U.S. regulatory landscape for perinatal stem cell and tissue products. The Society argues that while FDA guidance has driven innovation in the past, the current regulatory framework is now holding back advancements in regenerative medicine. The Society believes that these changes will help restore the U.S. as a global leader in regenerative medicine and biotechnology development.

Key points from the position paper include:

1. A proposal to adopt aspects of the Japanese regulatory model, which classifies regenerative medicine products into three risk categories.

2. Advocacy for a new regulatory pathway for “medium risk” products that fall between current 361 and 351 designations, such as expanded cellular products and exosomes.

3. A suggestion to allow clinical trial sponsors to charge patients for participation in Phase II and III trials for certain product categories, similar to the Japanese approach.

4. A call for clearer definitions and pathways to enable companies to bring stem cell and tissue-based products to market successfully while ensuring safety and efficacy.

“Our goal is to support improvements to the regulatory framework that advances healthcare options for patients while maintaining necessary safety standards,” said Kyle Cetrulo, President of the International Perinatal Stem Cell Society.

The full position paper is available on the Society’s website at www.perinatalstemcells.com

About the International Perinatal Stem Cell Society:

Founded in 2013, the International Perinatal Stem Cell Society is a 501(c)3 non-profit organization dedicated to advancing perinatal stem cell and tissue products from the laboratory to clinical applications.