Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2018 May 29:2018:1676851.
doi: 10.1155/2018/1676851. eCollection 2018.

Advantages of Graphene Biosensors for Human Stem Cell Therapy Potency Assays

Affiliations
Review

Advantages of Graphene Biosensors for Human Stem Cell Therapy Potency Assays

Roxana-Maria Amărandi et al. Biomed Res Int. .

Abstract

Regenerative medicine is challenged by the need to conform to rigorous guidelines for establishing safe and effective development and translation of stem cell-based therapies. Counteracting widespread concerns regarding unproven cell therapies, stringent cell-based assays seek not only to avoid harm but also to enhance quality and efficacy. Potency indicates that the cells are functionally fit for purpose before they are administered to the patient. It is a paramount quantitative critical quality attribute serving as a decisive release criterion. Given a broad range of stem cell types and therapeutic contexts the potency assay often comprises one of the most demanding hurdles for release of a cell therapy medicinal product. With need for improved biomarker assessment and expedited measurement, recent advances in graphene-based biosensors suggest that they are poised to be valuable platforms for accelerating potency assay development. Among several potential advantages, they offer versatility for sensitive measurement of a broad range of potential biomarker types, cell biocompatibility for direct measurement, and small sample sufficiency, plus ease of use and point-of-care applicability.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Biosensors for potency assay simplification. Traditional potency assay measurement technologies include (a) Protein expression via Sodium Dodecyl Sulphate-PolyAcrylamide Gel Electrophoresis (SDS-PAGE), (b) Gene expression via quantitative Real Time Polymerase Chain Reaction (qRT-PCR), (c) Live cell flow cytometry via Fluorescence-Activated Cell Sorting (FACS) analysis, or (d) Enzyme-Linked Immunosorbent Assay (ELISA) for antibody targets. These are typically multistep procedures requiring more time and expertise than needed for application of (e) dedicated biosensors tailored for specific target analytes.
Figure 2
Figure 2
Graphic representation of the relative number of stem cell clinical trials. (a) According to geographical region, (b) number of stem cells studies for each particular clinical phase.
Figure 3
Figure 3
Advantages of graphene biosensors for potency assays.

Similar articles

Cited by

References

    1. Boráň T., Menezes-Ferreira M., Reischl I., et al. Clinical Development and Commercialization of Advanced Therapy Medicinal Products in the European Union: How Are the Product Pipeline and Regulatory Framework Evolving? Human Gene Therapy Clinical Development. 2017 doi: 10.1089/humc.2016.193. - DOI - PubMed
    1. Corbett M. S., Webster A., Hawkins R., Woolacott N. Innovative regenerative medicines in the EU: A better future in evidence? BMC Medicine. 2017;15(1, article no. 49) doi: 10.1186/s12916-017-0818-4. - DOI - PMC - PubMed
    1. Robey P. "Mesenchymal stem cells": Fact or fiction, and implications in their therapeutic use. F1000Research. 2017;6, article no. 524 doi: 10.12688/f1000research.10955.1. - DOI - PMC - PubMed
    1. Sacchetti B., Funari A., Remoli C., et al. No identical "mesenchymal stem cells" at different times and sites: Human committed progenitors of distinct origin and differentiation potential are incorporated as adventitial cells in microvessels. Stem Cell Reports. 2016;6(6):897–913. doi: 10.1016/j.stemcr.2016.05.011. - DOI - PMC - PubMed
    1. Bianco P. ‘Mesenchymal’ stem cells. Annual Review of Cell and Developmental Biology. 2014;30(1):677–704. doi: 10.1146/annurev-cellbio-100913-013132. - DOI - PubMed

LinkOut - more resources