New review urges proteostatic fitness standards for stem cell therapies

https://www.news-medical.net/news/20260811/New-review-urges-proteostatic-fitness-standards-for-stem-cell-therapies.aspx Stem cell therapies have expanded rapidly, with more than 115 clinical trials involving over 1,200 patients approved by late 2024. The U.S. Food and Drug Administration (FDA) recently approved Ryoncil (remestemcel‑L) for children with steroid‑refractory acute graft‑versus‑host disease, signaling a major shift toward routine clinical use. Yet current Good Manufacturing Practice (GMP) standards primarily evaluate identity, viability, sterility, and genetic stability—checks that researchers say are necessary but insufficient. These standards provide little insight into how cells will cope with the oxidative and inflammatory stress encountered after transplantation. Given these challenges, a deeper investigation into the role of donor cell protein homeostasis in therapeutic outcomes is urgently needed.