ISO 24651:2022
(Main)Biotechnology — Biobanking — Requirements for human mesenchymal stromal cells derived from bone marrow
Biotechnology — Biobanking — Requirements for human mesenchymal stromal cells derived from bone marrow
This document specifies requirements for the biobanking of human mesenchymal stromal cells derived from bone marrow (hBM-MSCs), including the collection of bone marrow and associated data, isolation, culture, characterization, quality control, cryopreservation, storage, thawing, disposal, distribution and transport. This document is applicable to all organizations performing biobanking with hBM-MSCs used for research. This document does not apply to hBM-MSCs for the purpose of in vivo application in humans, cell therapy, clinical applications, tissue engineering or therapeutic use. NOTE International, national or regional regulations or requirements, or multiple of them, can also apply to specific topics covered in this document.
Biotechnologie — Biobanking — Exigences relatives aux cellules stromales mésenchymateuses dérivées de la moelle osseuse
General Information
Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 24651
First edition
2022-08
Biotechnology — Biobanking
— Requirements for human
mesenchymal stromal cells derived
from bone marrow
Biotechnologie — Biobanking — Exigences relatives aux cellules
stromales mésenchymateuses dérivées de la moelle osseuse
Reference number
© ISO 2022
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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 . 7
5.1 General . 7
5.2 Personnel, facilities and equipment . 7
5.3 Reagents, consumables and other supplies . 8
5.4 Management of information and data . 8
6 Collection of bone marrow samples and associated data . 8
6.1 Information about the bone marrow donor . 8
6.2 Anatomical collection site . 9
6.3 Collection volume . 9
6.4 Collection procedure . 9
6.4.1 General . 9
6.4.2 Obtaining bone marrow by puncturing into the intramedullary canal . 10
6.4.3 Obtaining bone marrow by aspirate . 10
7 Transport of bone marrow samples or hBM-MSCs and associated data to the
biobank .10
8 Reception and traceability of bone marrow or hBM-MSCs and associated data .10
9 Isolation and expansion of hBM-MSCs .11
9.1 Processes . 11
9.2 Unique identification . 11
9.3 Testing for infectious agents . 11
9.4 Isolation of hBM-MSCs from bone marrow samples obtained by puncturing into
the intramedullary canal and primary culture . 11
9.5 Isolation of hBM-MSCs from bone marrow samples obtained by aspirate and
primary culture .12
9.6 Subculture and limited expansion .12
10 Characterization of hBM-MSCs .12
10.1 General .12
10.2 Viability .13
10.3 Morphology . 13
10.4 Population doubling time and subculture/passage. 13
10.4.1 PDT . 13
10.4.2 Subculture/passage . 14
10.5 Cell population purity . 14
10.6 In vitro self-renewal assessment . 14
10.7 Proliferation . 14
10.8 Differentiation capability — In vitro multilineage differentiation .15
10.8.1 General .15
10.8.2 In vitro adipogenic differentiation . 15
10.8.3 In vitro chondrogeneic differentiation . 15
10.8.4 In vitro osteogenic differentiation . 16
10.9 Immunophenotyping by flow cytometry . 16
10.10 Paracrine secretion/expression (protein-based assay of secretome) . 17
10.11 Immunoregulation (modulation of immune cells) . 17
10.12 Microbial contamination . 18
iii
11 Quality control .19
12 Storage .19
13 Thawing .20
14 Disposal .20
15 Distribution of hBM-MSCs — Information for users .21
16 Transport of hBM-MSCs .21
16.1 General . 21
16.2 hBM-MSCs frozen in ampoules or cryovials . 22
16.3 Living hBM-MSC cultures. 22
Annex A (informative) Preparation of human bone marrow mononuclear cells (hBM-MNCs) .23
Bibliography .24
iv
Foreword
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v
Introduction
Mesenchymal stromal cells are a heterogeneous cell population that is characterized by multiple
functional properties including the ability to secrete paracrine factors, regulate immune effector
[8][9][10][11] [12][13]
cells, maintain primitive phenotypes of other cell populations and support tissue
[14][15]
regeneration. Mesenchyma
...
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