2021 Annual Meeting Biologics Access Pass-Amniotic Tissue: Fact or Fiction

Video Transcription

Video Summary

This presentation reviewed placental-derived biologics, focusing on amniotic tissue and stromal (MSC) cells. Placenta tissues, including amnion, chorion, and umbilical cord, offer high plasticity and growth factors. However, FDA regulations limit processing methods, making expanded stem cell injections for musculoskeletal disorders unavailable in the U.S. The recent FDA crackdown ended previously allowed sales. Literature shows confusion over nomenclature, limited dosing data, and mostly animal studies, though some promising human trials exist. Exosomes, critical for cell communication, represent a novel therapeutic avenue. Despite current challenges, ongoing clinical trials and improved science suggest future FDA-approved placental biologic injections for orthopedic use.

Asset Caption

Dr. C Thomas Vangsness

Keywords

placental-derived biologics

amniotic tissue

mesenchymal stromal cells

FDA regulations

orthopedic clinical trials