New Perinatal Stem Cell Law
In this video, Kyle Cetrulo, founder and president of the Perinatal Stem Cell Society, shares his background and vision for enacting change in the stem cell field. The goal is to create a new federal law and regulatory guidance system that allows stem cells from perinatal sources and tissue products to reach patients safely, efficaciously, and affordably.
Kyle's journey in the stem cell space began by supporting the International Cord Blood Society, which his father started in 1991. He then founded Auxocell Laboratories, Inc. the first company focusing on stem cells from umbilical cord tissue, and formed the Perinatal Stem Cell Society in 2013. The society has been advocating for patient rights and access to perinatal tissue products for over a decade, hosting 10 international congresses and leading the way in bringing safe and effective products to patients.
The current system is broken, and these incredible healing tools, when manufactured correctly and safely, should be in the hands of United States doctors to administer to their patients. The proposed solution is to revolutionize the approach by introducing a federal law mirroring the Japanese Regenerative Medicine Act. Under this act, companies pay for a phase one safety clinical trial, and if it shows efficacy, they can charge patients to join phase two and three trials. This data is then submitted to the FDA for full market approval, after which insurance should cover the use of these products, and manufacturers can advertise for specific indications.
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