Hadassah, provider of "Regulatory-Ready" pluripotent clinical-grade stem cell banks

Shelly E Tannenbaum; Orna Singer; Yaniv Gil; Yael Berman-Zaken; Nili Ilouz; Hanita Khaner; Miriam Haimov; Benjamin E Reubinoff

doi:10.1016/j.scr.2019.101670

Hadassah, provider of "Regulatory-Ready" pluripotent clinical-grade stem cell banks

Stem Cell Res. 2020 Jan:42:101670. doi: 10.1016/j.scr.2019.101670. Epub 2019 Nov 26.

Authors

Shelly E Tannenbaum¹, Orna Singer², Yaniv Gil³, Yael Berman-Zaken⁴, Nili Ilouz⁵, Hanita Khaner⁶, Miriam Haimov⁷, Benjamin E Reubinoff⁸

Affiliations

¹ The Hadassah Human Embryonic Stem Cell Research Center, the Goldyne Savad Institute of Gene Therapy, Hadassah Hebrew University Medical Center, Jerusalem, Israel. Electronic address: stannenbaum@hadassah.org.il.
² The Hadassah Human Embryonic Stem Cell Research Center, the Goldyne Savad Institute of Gene Therapy, Hadassah Hebrew University Medical Center, Jerusalem, Israel. Electronic address: ornasi@hadassah.org.il.
³ The Hadassah Human Embryonic Stem Cell Research Center, the Goldyne Savad Institute of Gene Therapy, Hadassah Hebrew University Medical Center, Jerusalem, Israel. Electronic address: yanivgil25@hotmail.com.
⁴ The Hadassah Human Embryonic Stem Cell Research Center, the Goldyne Savad Institute of Gene Therapy, Hadassah Hebrew University Medical Center, Jerusalem, Israel. Electronic address: yaelber@gmail.com.
⁵ The Hadassah Human Embryonic Stem Cell Research Center, the Goldyne Savad Institute of Gene Therapy, Hadassah Hebrew University Medical Center, Jerusalem, Israel. Electronic address: nilib@hadassah.org.il.
⁶ The Hadassah Human Embryonic Stem Cell Research Center, the Goldyne Savad Institute of Gene Therapy, Hadassah Hebrew University Medical Center, Jerusalem, Israel. Electronic address: hanitak@hadassah.org.il.
⁷ The Hadassah Human Embryonic Stem Cell Research Center, the Goldyne Savad Institute of Gene Therapy, Hadassah Hebrew University Medical Center, Jerusalem, Israel. Electronic address: Mirihaim731@gmail.com.
⁸ The Hadassah Human Embryonic Stem Cell Research Center, the Goldyne Savad Institute of Gene Therapy, Hadassah Hebrew University Medical Center, Jerusalem, Israel; Department of Obstetrics and Gynecology, Hadassah Hebrew University Medical Center, Jerusalem, Israel. Electronic address: BenR@hadassah.org.il.

PMID: 31838378
DOI: 10.1016/j.scr.2019.101670

Abstract

The Hadassah hESC Research Center's aim is to be a supplier of clinical and research-grade human embryonic stem cell (hESC) lines. In 2012, we derived the first three entirely GMP-compliant and xeno-free, fully-characterised, feeder-dependent (human umbilical cord) hESC lines developed under cleanroom conditions. In 2018, we established four new GMP and xeno-free, feeder-independent MCB hESCs under GMP conditions using commercially available reagents, media and matrix. All cell lines were derived under Israeli Ministry of Health's National Ethics Committee for Genetic Research in Humans and the ethical considerations that guided the development of the hESCs strictly followed Israeli law. Hadassah has provided its clinical-grade hESC lines to commercial entities of which two are already in clinical trials, establishing Hadassah as a key provider of clinical-grade hESC lines.

Keywords: Biosafety testing; Certificate of analysis; Clinical-grade hESC lines; Disease-affected hESC lines; QC testing; Transplantation therapy; Xeno-free.

Publication types

Research Support, Non-U.S. Gov't
Review

MeSH terms

Cell Culture Techniques / methods*
Cell Differentiation
Embryonic Stem Cells / metabolism*
Humans
Pluripotent Stem Cells / metabolism*