Stem cell-derived gametes: what to expect when expecting their clinical introduction

Area of Science:

• Reproductive Medicine
• Stem Cell Biology
• Bioethics

Background:

• Stem cell-derived gametes (SCD-gametes) show promise for addressing human fertility issues.
• Advancements in mouse models suggest potential for human induced pluripotent stem cell-derived gametes (iPSCD-gametes) within two decades.
• Significant technical, ethical, legal, and societal considerations require thorough investigation before clinical application.

Purpose of the Study:

• To review the current state of SCD-gamete technology.
• To highlight the multifaceted challenges associated with the clinical introduction of human iPSCD-gametes.
• To encourage investigation into the realistic timelines and necessary considerations for iPSCD-gamete development.

Main Methods:

• Mini-review of existing literature on SCD-gametes.
• Analysis of issues emerging before, during, and after clinical trials (Stages 1-3).
• Discussion of safety, effectiveness, accountability, and legal frameworks.

Main Results:

• Preclinical assessment (Stage 1) requires extensive, time-consuming research.
• Clinical trials (Stage 2) will likely be lengthy due to quality variations and regulatory processes.
• Post-trial implementation (Stage 3) necessitates addressing complex legal and accountability issues.

Conclusions:

• The clinical introduction of human iPSCD-gametes may take longer than anticipated.
• Transdisciplinary collaboration is crucial for informed decision-making in iPSCD-gamete development and application.
• Addressing safety, efficacy, and ethical concerns is paramount for responsible innovation.