Why Gender Representation Matters in Regenerative Medicine Research

Regenerative medicine could transform the treatment of chronic and life-threatening diseases. Yet the field is still developing on an incomplete scientific foundation because women and non-binary people remain underrepresented in preclinical and clinical research. This is more than an oversight: it can compromise the safety, accuracy and real-world effectiveness of new treatments.

Cardiovascular disease (CVD) is the leading cause of death worldwide, underscoring the scale of this disparity. Despite well-documented gender differences in CVD prevalence, symptoms and biology, women account for approximately 41% of participants in all CVD clinical trials but only 18–20% of participants in CVD regenerative medicine trials, according to a 2021 analysis.¹ As a result, research findings may not apply equally to everyone, perpetuating the notion that women are simply “little men.” People who identify as non-binary have largely been excluded from these studies.

Women and non-binary people may therefore miss out on potentially beneficial treatments, while safety risks can remain hidden until therapies enter routine clinical practice. A structured approach is needed—one focused on recruitment, retention and rigorous gender-based reporting.

Recruitment: Build representative regenerative medicine trials

Including women and non-binary people in regenerative medicine trials requires intentional study design and implementation, rather than passive inclusion. Barriers such as underdiagnosis and limited awareness of sex-specific disease manifestations among sponsors and clinical researchers contribute to low enrollment. It was only a decade ago that the medical community began to widely recognize differences in heart attack symptoms between men and women.

These barriers are structural but solvable. Increasing the number of women and non-binary researchers and leaders in regenerative medicine is critical. Research shows that women-led teams enroll more women, ask more comprehensive research questions and prioritize outcomes relevant to diverse populations.² Representation in leadership helps shape representation in science.

Retention: Make clinical trial participation sustainable

Recruitment alone is not enough if women and non-binary people do not remain in research long enough to support meaningful analysis. Women leave clinical trials at higher rates than men, often because of social pressures such as caregiving responsibilities.³ These factors can skew the data and disproportionately obscure women’s responses to treatment.

Retention challenges also affect the research workforce. Women faculty leave academia at higher rates than their male colleagues at all career stages, including after tenure. Harassment, discrimination and dysfunctional leadership are among the workplace issues cited as key factors in women leaving—or considering leaving—their jobs.⁴

Reporting: Analyze and publish gender-specific outcomes

One of the clearest indicators of systemic bias is the limited use of gender-disaggregated reporting. Although 98% of CVD randomized clinical trials include sex or gender in participant descriptions, only 4% report gender-disaggregated outcomes. This leaves an alarming gap between the data collected and the data analyzed.⁵

The gap is even wider in regenerative medicine. In 2024, fewer than 2% of regenerative medicine CVD studies listed on ClinicalTrials.gov reported gender-specific results.

A 2021 analysis found that female participants in a trial of autologous cardiovascular cell therapy—which uses a patient’s own cells to repair heart structure and function—had significantly lower rates of stroke, heart attack and death than the placebo group. No comparable advantage was observed in men.

Without gender-specific analysis, this difference could have remained hidden, delaying clinical approval and limiting access to potentially life-saving treatments. More representative recruitment, stronger retention strategies and transparent reporting are essential to ensure that regenerative medicine is safe and effective for everyone.