Let's Talk About Sex—Biological Sex Is Underreported in Biomaterial Studies

Abstract

Precision medicine aims to better individualize healthcare. It requires that biomaterials be designed for the physiological characteristics of a specific patient. To make this a reality, biomaterials research and development must address differences of biological sex. More specifically, biomaterials should be designed with properties optimized and appropriate for male and female patients. In analyzing research articles from seven prominent biomaterials journals, sex as a biological variable is missing from an overwhelming majority of in vitro biomaterial studies. From the survey, the reporting of the sex of primary cell cultures happened only 10.3% of the time. Contributing to this trend is that commercial vendors bias cell lines toward one sex or another by not disclosing information of cell line sex at the time of purchase; researchers do not communicate this pertinent information in published studies; and many journal policies have little to no requirements for reporting cell line characteristics. Omitting this valuable information leads to a gap in the understanding of sex‐specific cell‐biomaterial interactions and it creates a bias in research findings towards one sex or another. To curb this concerning trend and make precision biomaterials a reality will require the biomaterials field to “talk about sex” by reporting cell sex more broadly.

Ancestral Background Is Underreported in Regenerative Engineering

“…For every journal article found, we recorded the body tissue the cells were derived from, whether the cells were from an immortalized cell line, the ancestry identified either specifically stated in the paper or inferred from outside sources such as public databases or cell suppliers, and the sex of the cells. Our research involving the race/ancestry of the cells found a lack of representation in literature which holds to the finding of previous work [11,12].…”

Sex‐Specific Response to Combinations of Shear Stress and Substrate Stiffness by Endothelial Cells In Vitro

“…It is necessary to make this validation as this information may not be provided or be accurate from the vendor. [25] PCR was used to amplify in a single reaction a region of the sex-determining region Y (SRY) gene, specifically the region for testis-determining factor (TDF) (males only), and a region of the HLA-DQ gene, an internal control found on chromosome 6 (both males and females). [54] (The protocol uses two primer sets (Table 2) to amplify in a single reaction a region of the SRY gene, specifically the region for TDF (males only), and a region of the HLA-DQ gene, an internal control found on chromosome 6 (both males and females)).…”

Nanomaterials alleviating redox stress in neurological diseases: mechanisms and applications

“…Therefore, work involving human subjects requires a more rigorous safety and efficacy assessment of the NMs. Moreover, the development, progression mechanisms, and extent of many neurological diseases, especially neurodegenerative diseases, are closely related to the biological sex, age, and ancestral background of the disease models used for research, which is often neglected in biomaterials research [ 171 , 172 ], especially NM studies focused on redox stress-related neurological diseases. These factors should be carefully considered, as they may play a crucial role in neurological diseases for the reasons discussed as follow: First, there is sex.…”