Advantages of Graphene Biosensors for Human Stem Cell Therapy Potency Assays

BioMed Research International
Roxana-Maria AmărandiJorge S Burns

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.

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Citations

Oct 24, 2018·International Journal of Molecular Sciences·Diana F BecheruJorge S Burns
May 9, 2019·Stem Cells International·Dinesh K PatelKi-Taek Lim

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Methods Mentioned

BETA
biosensors
biosensor
ELISA
enzyme-linked immunosorbent assay
Assay
biosensing

Clinical Trials Mentioned

NCT03280056
NCT02730299
NCT01552707
NCT02230514
NCT01605383
NCT02381366
NCT02890953
NCT02504619
NCT03173937
NCT02054208

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