Introduction

Mesenchymal stromal cells are a heterogeneous cell population that is characterized by multiple functional properties including the ability to secrete paracrine factors,^[⁸^] regulate immune effector cells,^[⁹^][¹⁰^] maintain primitive phenotypes of other cell populations^[¹¹^][¹²^] and support tissue regeneration.^[¹³^][¹⁴^] Mesenchymal stromal cells can contain a sub-population of stem or progenitor cells that demonstrate in vitro self-renewal and differentiation, as has been rigorously demonstrated for umbilical cord-derived progenitor cells.^[¹⁵^]

Mesenchymal stromal cells and mesenchymal stem cells are both abbreviated as “MSCs”.^[¹⁶^] For the purpose of this document, the abbreviated term “MSCs” refers to mesenchymal stromal cells.

The functional definition of MSCs has evolved over time as the biology of these cells is better understood. Despite these advances, substantial ambiguities persist regarding the nomenclature, nature, identity, function, mode of isolation and experimental handling of these cells. MSCs are not fully defined by the initial minimal criteria^[¹⁷^] proposed by the International Society of Cell and Gene Therapy (ISCT), and as such require careful characterization by a matrix of functional assays.^[¹⁶^]

MSCs have been isolated from umbilical cord^[¹⁵^], bone marrow^[¹⁸^][¹⁹^] and other tissue sources, and are widely used for non-clinical research. MSCs from different tissue sources have different properties. Different institutions use different practices for isolating, processing and biobanking these MSCs, making it difficult to compare data and results across institutions. Thus, there is a need for standardized approaches to isolate, process, expand and cryopreserve these MSCs from specific tissue sources.

This document provides requirements for biobanking of human mesenchymal stromal cells derived from umbilical cord tissue (Wharton’s jelly) (hUC-MSCs) for research purposes. This document is applicable for academic centres, public and private institutions performing a biobanking service of hUC-MSCs for research and development (R&D) and preclinical studies, not for clinical use.

Importantly, this document is focused on MSCs that have been isolated, manipulated and/or propagated from umbilical cord tissue (also called “Wharton’s jelly”) in culture for research purposes. These cells are different from unmanipulated cells found in human umbilical cord tissue (Wharton’s jelly).

ISBT 128^[²⁰^] provides terminology and abbreviations for all medicinal products including cell therapy, and abbreviates these as “MSC(WJ)” to denote mesenchymal stromal cells from Wharton’s jelly. This document recognizes this abbreviation, but uses the more commonly-used convention in research to denote human mesenchymal stromal cells derived from umbilical cord tissue (Warton’s jelly) (hUC-MSCs).^[²¹^]

PD ISO/TS 22859-1:2022

Biotechnology. Biobanking. Requirements for human mesenchymal stromal cells derived from umbilical cord tissue

Current, Under Review

Published:

31 Aug 2022