Toward clone-on-a-chip: Ethical and legal considerations for organ-on-a-chip evolution


KARABEKMEZ M. E., Ebrahimi A., GHORBANPOOR H., Bassous N., Shin S. R., Zhang Y. S., ...Daha Fazla

BMEMat, 2026 (ESCI, Scopus) identifier

  • Yayın Türü: Makale / Tam Makale
  • Basım Tarihi: 2026
  • Doi Numarası: 10.1002/bmm2.70096
  • Dergi Adı: BMEMat
  • Derginin Tarandığı İndeksler: Emerging Sources Citation Index (ESCI), Scopus
  • Anahtar Kelimeler: clone-on-a-chip, drug discovery, ethical and legal concerns, in vitro platform, microphysiological system, organ-on-a-chip
  • Eskişehir Osmangazi Üniversitesi Adresli: Evet

Özet

Organ-on-a-chip (OoC) is a promising technology that can be used to investigate tissue formation, organ function, and disease etiology as well as an in vitro test platform for evaluating drug and radiation efficacies along with their side effects. The OoC technology provides substantial advantages like the ability to precisely control cellular processes in microenvironments for extended periods and the ease of applying a diffusion gradient to improve pharmacokinetics and pharmacodynamics. As a precursor to personalized medicine, the OoC systems are expected to serve as a milestone technology, especially after the United States Food and Drug Administration Modernization Act 2.0, and more recently, 3.0. Of importance, the OoC platforms could be engineered to produce genetically identical or near-identical tissue and organ models derived from an individuals' cells, enabling detailed studies of specific genetic and epigenetic phenotypes and better capturing interpersonal differences. To describe this conceptual extension, we introduce the term “clone-on-a-chip (CoC)” as a conceptual warning and not to suggest technological feasibility; also referring not to whole-organism cloning but to the replication of patient-specific biological profiles in vitro for personalized therapeutics development and testing. This approach holds unique potential for tailoring therapeutic strategies; however, future projections may present new ethical dilemmas. A CoC ethical discussion extends beyond issues arising from the requirements for informed consent, property rights, commercialization efforts, and cell sourcing to include potentially controversial applications and societal concerns.