Int J Stem Cells.  2024 May;17(2):130-140. 10.15283/ijsc24046.

Guidelines for Manufacturing and Application of Organoids: Heart

• Lee HA
• Woo DH
• Lim DS
• Oh J
• Kim CY
• Bae ON
• Ahn SJ

• KMID: 2556232
• DOI: http://doi.org/10.15283/ijsc24046

Abstract

Cardiac organoids have emerged as invaluable tools for assessing the impact of diverse substances on heart function. This report introduces guidelines for general requirements for manufacturing cardiac organoids and conducting cardiac organoid-based assays, encompassing protocols, analytical methodologies, and ethical considerations. In the quest to employ recently developed three-dimensional cardiac organoid models as substitutes for animal testing, it becomes imperative to establish robust criteria for evaluating organoid quality and conducting toxicity assessments. This guideline addresses this need, catering to regulatory requirements, and describes common standards for organoid quality and toxicity assessment methodologies, commensurate with current technological capabilities. While acknowledging the dynamic nature of technological progress and the potential for future comparative studies, this guideline serves as a foundational framework. It offers a comprehensive approach to standardized cardiac organoid testing, ensuring scientific rigor, reproducibility, and ethical integrity in investigations of cardiotoxicity, particularly through the utilization of human pluripotent stem cell-derived cardiac organoids.

Keyword

Cardiac organoids; Quality control; Organoid manufacturing; Requirements; Non-clinical testing; Standard protocol

Figure

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  Fig. 1 Comprehensive process for cardiac organoid manufacturing. EB: embryoid body, ESCs: embryonic stem cells, iPSCs: induced pluripotent stem cells, QC: quality control, ECM: extracellular matrix.

Reference

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