ISO/TS 22859:2022

TECHNICAL ISO/TS
SPECIFICATION 22859
First edition
2022-07
Biotechnology — Biobanking
— Requirements for human
mesenchymal stromal cells derived
from umbilical cord tissue
Biotechnologie — Banques biologiques — Exigences relatives aux
cellules stromales mésenchymateuses humaines issues des tissus du
cordon ombilical
Reference number
© ISO 2022
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
Contents Page
Foreword .v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviated terms and symbols .5
5 General requirements .10
5.1 General . 10
5.2 Personnel, facilities and equipment . 10
5.3 Reagents, consumables and other supplies . 11
5.4 Management of information and data . 11
6 Collection of umbilical cord and associated data .11
6.1 Information about the umbilical cord donor . 11
6.2 Collection procedure .12
7 Transport of umbilical cord or hUC-MSCs and associated data to the biobank .13
8 Reception and traceability of umbilical cord tissue or hUC-MSCs and associated data .13
9 Isolation and expansion of hUC-MSCs .13
9.1 Processes .13
9.2 Unique identification . 13
9.3 Testing for infectious agents . 14
9.4 Isolation of hUC-MSCs and primary culture . 14
9.5 Subculture and limited expansion . 14
10 Characterization of hUC-MSCs .14
10.1 General . 14
10.2 Viability . 15
10.3 Morphology . 15
10.4 Population doubling time and subculture/passage. 16
10.4.1 PDT . 16
10.4.2 Subculture/passage . 16
10.5 Cell population purity . 16
10.6 In vitro self-renewal assessment . 17
10.7 Proliferation . 17
10.8 Differentiation capability — In vitro multilineage differentiation . 17
10.8.1 General . 17
10.8.2 In vitro adipogenic differentiation . 17
10.8.3 In vitro chondrogenic differentiation . 18
10.8.4 In vitro osteogenic differentiation . 18
10.9 Immunophenotyping by flow cytometry . 18
10.10 Paracrine secretion/expression (protein-based assay of secretome) .20
10.11 Immunoregulation (modulation of immune cells) . 20
10.12 Microbial contamination . 21
11 Quality control .21
12 Storage .22
13 Thawing .23
14 Disposal .24
15 Distribution of hUC-MSCs — Information for users .24
16 Transport of hUC-MSCs .24
iii
16.1 General . 24
16.2 hUC-MSCs frozen in ampoules or cryovials . 25
16.3 Living hUC-MSC cultures . 25
Annex A (informative) Exemplary quality control test procedure for biobanking of hUC-
MSCs .27
Annex B (informative) Examples for suitable methods for the isolation and primary culture
of hUC-MSCs .28
Annex C (informative) Exemplary methods for characterization of hUC-MSCs .30
Bibliography .32
iv
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO’s adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/
iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 276, Biotechnology.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
v
Introduction
Mesenchymal stromal cells are a heterogeneous cell population that is characterized by multiple
[8]
functional properties including the ability to secrete paracrine factors, regulate immune effector
[9][10] [11][12]
cells, maintain primitive phenotypes of other cell populations and support tissue
[13][14]
regeneration. 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
[15]
umbilical cord-derived progenitor cells.
[16]
Mesenchymal stromal cells and mesenchymal stem cells are both abbreviated as “MSCs”. 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
...