inStem (Institute for Stem Cell Science and Regenerative Medicine)

Department of Biotechnology
Department of Biotechnology
inStem (Institute for Stem Cell Science and Regenerative Medicine)

Charting the translational pathway: ISSCR best practices for the development of PSC-derived therapies.

Publication Type

Journal Article

Date of Publication

February 10, 2026

Journal

Stem cell reports

Volume/Issue

21/2

ISSN

2213-6711

The successful translation of a stem cell-derived product from the laboratory into an approved medicine requires specific scientific, technical, and regulatory understanding. Since this knowledge base is fragmented across websites and publications, the ISSCR has developed a new resource, The Best Practices for the Development of Pluripotent Stem Cell-Derived Therapies. This comprehensive, interactive document, designed for academia and industry, addresses critical areas of the translational pipeline and key decision points for the successful translation to a licensed therapy. Uniquely, it provides a global perspective of the regulatory landscape while providing resources for critical processes and links to jurisdictional regulatory information.

Alternate Journal

Stem Cell Reports

PubMed ID

41576937

PubMed Central ID

PMC12903078

Authors

Barry J
Abranches E
Baptista RP
Barry C
Brandsten C
Bruce K
Carpenter MK
Cavagnaro J
Collins L
Csaszar E
Dashnau J
de Villa D
Fynes K
Gabaldo M
Hao J
Harel-Adar T
Hei D
Henchcliffe C
Hidalgo-Simon A
Hollands J
Hursh D
Jackman S
Kelly K
Kim JH
Kim H
Kino-Oka M
Lakshmipathy U
Lamb T
Lazic SE
Loring JF
Ludwig TE
Mariappan I
Monville C
Mountford JC
Nagy A
Okano H
Pellegrini G
Persson A
Prutton K
Rasko JEJ
Sareen D
Sato Y
Shnaiderman A
Stacey G
Svendsen CN
Tomishima M
Trounson A
Viswanathan S
Wang S
Wydenbach K
Zhang A
Zylberberg C
Mosher JT
Bharti K

Keywords

Animals
Humans
Pluripotent Stem Cells
Translational Research
Biomedical