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ASTM F3106-14

(Guide)

Standard Guide for in vitro Osteoblast Differentiation Assays

Standard Guide for <emph type="bdit">in vitro</emph> Osteoblast Differentiation Assays

SIGNIFICANCE AND USE
4.1 This guidance document describes the components and conditions used for in vitro osteoblast differentiation assays that can be used to screen for the osteogenic capability of progenitor stem cells from various human or animal sources, including mixed tissue-derived connective tissue progenitor populations, or cell populations that may be selectively isolated or manipulated through culture expansion, processing, transfection or genetic modification.  
4.2 The osteoblast differentiation assay may be referred to as an osteogenesis assay or a mineralization assay.  
4.3 It is important to carefully select the components and conditions used for in vitro osteoblast differentiation assays since high amounts of osteogenic medium components can lead to dystrophic, pathologic or artifactual calcium-based precipitates that do not indicate differentiation of the cells in culture to functional osteoblasts (1).3 For example, when high concentrations of beta-glycerophosphate are used in the medium to function as a substrate for the enzyme alkaline phosphatase secreted by the cells, there is a marked increase in free phosphate, which then precipitates with Ca++ ions in the media to form calcium phosphate crystals independently of the differentiation status of the progenitor cell (2, 3).  
4.4 Alkaline phosphatase production is an early event associated with osteoblast differentiation but it can also be stimulated in other cell types by the addition of the osteogenic supplement dexamethasone to the medium. Alkaline phosphatase enhances the formation of calcified deposits prior to their natural occurrence in bone that typically coincides with bone sialoprotein and osteocalcin expression by mineralized matrix-producing osteoblasts. These kinds of calcified/mineral deposits are thus considered dystrophic, pathologic, or artifactual because they were not initiated by a mature osteoblast. A calcium measurement, such as that described in Practice F2997 for the Quantification of Cal...
SCOPE
1.1 This document provides guidance on how to conduct in vitro osteoblast differentiation assays with progenitor stem cells including mesenchymal stromal cells.  
1.2 This document describes the roles of various osteogenic supplements that are added to the cell culture medium of an osteoblast differentiation assay to encourage and support the differentiation of progenitor cells into matrix-producing osteoblasts.  
1.3 This document provides recommendations for the concentrations of osteogenic supplements that may prevent the precipitation of artifactual mineral deposits that are not directly produced by osteoblasts, nor correlated with osteoblastic gene expression of the cells.  
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

General Information

Status
Historical
Publication Date
30-Sep-2014
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.43 - Cells and Tissue Engineered Constructs for TEMPs
Current Stage
Ref Project

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ASTM F3106-14 - Standard Guide for <emph type="bdit">in vitro</emph> Osteoblast Differentiation AssaysASTM F3106-14 - Standard Guide for <emph type="bdit">in vitro</emph> Osteoblast Differentiation Assays
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ASTM F3106-14 - Standard Guide for <emph type="bdit">in vitro</emph> Osteoblast Differentiation Assays
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F3106 − 14
Standard Guide for
1
in vitro Osteoblast Differentiation Assays
This standard is issued under the fixed designation F3106; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope osteoblast differentiation assays that may be directly produced
by osteoblasts or precipitated out of the solution without cell
1.1 This document provides guidance on how to conduct in
participation.
vitro osteoblast differentiation assays with progenitor stem
3.2.2 mineralized matrix, n—a calcium phosphate-
cells including mesenchymal stromal cells.
containing substance produced by cells typically in the
1.2 This document describes the roles of various osteogenic
osteoblast, odontoblast, and calcifying chondrocyte lineages,
supplements that are added to the cell culture medium of an
which is composed of crystals of calcium phosphate and
osteoblast differentiation assay to encourage and support the
contains collagen Type I and other non-collagenous proteins.
differentiation of progenitor cells into matrix-producing osteo-
3.2.3 osteoblasts, n—secretory mononuclear cells that will
blasts.
initiate the formation of a matrix containing characteristic
1.3 This document provides recommendations for the con-
proteins, such as collagen, and non-collageneous proteins such
centrations of osteogenic supplements that may prevent the
as bone sialoprotein and osteocalcin, that will mineralize in the
precipitationofartifactualmineraldepositsthatarenotdirectly
presence of a calcium and phosphate source.
produced by osteoblasts, nor correlated with osteoblastic gene
expression of the cells.
4. Significance and Use
1.4 This standard does not purport to address all of the
4.1 This guidance document describes the components and
safety concerns, if any, associated with its use. It is the
conditions used for in vitro osteoblast differentiation assays
responsibility of the user of this standard to establish appro-
that can be used to screen for the osteogenic capability of
priate safety and health practices and determine the applica-
progenitor stem cells from various human or animal sources,
bility of regulatory limitations prior to use.
including mixed tissue-derived connective tissue progenitor
populations,orcellpopulationsthatmaybeselectivelyisolated
2. Referenced Documents
or manipulated through culture expansion, processing, trans-
2
2.1 ASTM Standards:
fection or genetic modification.
F2312 Terminology Relating to Tissue Engineered Medical
4.2 The osteoblast differentiation assay may be referred to
Products
as an osteogenesis assay or a mineralization assay.
F2997 Practice for Quantification of Calcium Deposits in
4.3 It is important to carefully select the components and
Osteogenic Culture of Progenitor Cells Using Fluorescent
conditions used for in vitro osteoblast differentiation assays
Image Analysis
since high amounts of osteogenic medium components can
3. Terminology
lead to dystrophic, pathologic or artifactual calcium-based
precipitates that do not indicate differentiation of the cells in
3.1 Unless provided otherwise in 3.2, terminology shall be
3
culture to functional osteoblasts (1). For example, when high
in conformance with Terminology F2312.
concentrations of beta-glycerophosphate are used in the me-
3.2 Definitions:
dium to function as a substrate for the enzyme alkaline
3.2.1 calcium deposits, n—a calcium phosphate-containing
phosphatase secreted by the cells, there is a marked increase in
substance synthesized in cell cultures during mineralization or ++
free phosphate, which then precipitates with Ca ions in the
media to form calcium phosphate crystals independently of the
1
This test method is under the jurisdiction ofASTM Committee F04 on Medical
differentiation status of the progenitor cell (2, 3).
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
4.4 Alkaline phosphatase production is an early event asso-
F04.43 on Cells and Tissue Engineered Constructs for TEMPs.
Current edition approved Oct. 1, 2014. Published February 2015. DOI: 10.1520/
ciated with osteoblast differentiation but it can also be stimu-
F3106-14.
lated in other cell types by the addition of the osteogenic
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
3
Standards volume information, refer to the standard’s Document Summary page on The boldface numbers in parentheses refer to the list of references at the end of
the ASTM website. this standard.
Copyright © ASTM International, 100 Barr Harbor Dri
...

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A1.1 Significance and Use
A1.1.1 This test method is used to measure the torsional yield strength, maximum torque, and breaking angle of the bone screw under standard conditions. The results obtained in this test method are not intended to predict the torque encountered while inserting or removing a bone screw in human or animal bone. This test method is intended only to measure the uniformity of the product tested or to compare the mechanical properties of different, yet similarly sized, products.
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SCOPE
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1.7 This document is a guide. As defined by ASTM in their “Form and Style for ASTM Standards” book in section C15.2, “A standard guide is a compendium of information or series of options that does not recommend a specific course of action. Guides are intended ...

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SCOPE
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1.2 Hard-on-hard hip bearing systems include metal-on-metal (for example, Specifications F75, F799, and F1537; ISO 5832-4, ISO 5832-12), ceramic-on-ceramic (for example, ISO 6474-1, ISO 6474-2, ISO 13356), ceramic-on-metal, or any other bearing systems where both the head and cup components have high surface hardness. An argument has been made that the hard-on-hard THR articulation may be better for younger, more active patients. These younger patients may be more physically fit and expect to be able to perform more energetic activities. Consequently, new designs of hard-on-hard THR articulations may have some implantations subjected to more demanding and longer wear performance requirements.  
1.3 Total Hip Replacement (THR) with metal-on-metal articulations have been used clinically for more than 50 years (1, 2).2 Early designs had mixed clinical results. Eventually they were eclipsed by THR systems using metal-on-polyethylene articulations. In the 1990s the metal-on-metal articulation again became popular with more modern designs (3), including surface replacement.  
1.4 In the 1970s the first ceramic-on-ceramic THR articulations were used. In general, the early results were not satisfactory (4, 5). Improvement in alumina, and new designs in the 1990s improved the results for ceramic-on-ceramic articulations (6).  
1.5 The values stated in SI units are to be regarded as the standard.  
1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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    English language
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