title: Derivation of xeno-free and GMP-grade human embryonic stem cells--platforms for future clinical applications.
abstract: Clinically compliant human embryonic stem cells (hESCs) should be developed in adherence to ethical standards, without risk of contamination by adventitious agents. Here we developed for the first time animal-component free and good manufacturing practice (GMP)-compliant hESCs. After vendor and raw material qualification, we derived xeno-free, GMP-grade feeders from umbilical cord tissue, and utilized them within a novel, xeno-free hESC culture system. We derived and characterized three hESC lines in adherence to regulations for embryo procurement, and good tissue, manufacturing and laboratory practices. To minimize freezing and thawing, we continuously expanded the lines from initial outgrowths and samples were cryopreserved as early stocks and banks. Batch release criteria included DNA-fingerprinting and HLA-typing for identity, characterization of pluripotency-associated marker expression, proliferation, karyotyping and differentiation in-vitro and in-vivo. These hESCs may be valuable for regenerative therapy. The ethical, scientific and regulatory methodology presented here may serve for development of additional clinical-grade hESCs.
authors: Goldyne Savad Institute of Gene Therapy, Hadassah Hebrew University Medical Center, Jerusalem, Israel.
authors: Shelly E
authors: SE
authors: Tannenbaum
authors: Tikva Tako
authors: TT
authors: Turetsky
authors: Orna
authors: O
authors: Singer
authors: Einat
authors: E
authors: Aizenman
authors: Sophie
authors: S
authors: Kirshberg
authors: Nili
authors: N
authors: Ilouz
authors: Yaniv
authors: Y
authors: Gil
authors: Yael
authors: Y
authors: Berman-Zaken
authors: Temima Schnitzer
authors: TS
authors: Perlman
authors: Nitshia
authors: N
authors: Geva
authors: Ora
authors: O
authors: Levy
authors: Daniel
authors: D
authors: Arbell
authors: Alex
authors: A
authors: Simon
authors: Assaf
authors: A
authors: Ben-Meir
authors: Yoel
authors: Y
authors: Shufaro
authors: Neri
authors: N
authors: Laufer
authors: Benjamin E
authors: BE
authors: Reubinoff
mesh_terms: D018929:Cell Culture Techniques / Q000941:ethics / Q000379:methods*; D053595:Embryonic Stem Cells / Q000166:cytology*; D006801:Humans