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Literature Review: Final Draft

The Regenerative Potential of Stem Cell Cloning in Biomedicine: An exploration into the biomedical advantages of utilizing stem cells in regenerative procedures and organ transplantation.

Ryan Elsebai

The Division of Science, The City College of New York

ENGL 21003: Writing for the Sciences

Professor Brittany Zayas

April 1, 2025

Stem cell research and cloning represent groundbreaking advancements in biomedical science with far-reaching implications for regenerative medicine. These technologies have the potential to revolutionize treatments for degenerative diseases, organ failure, and genetic disorders. Certain types of stem cells possess the unique ability to change into any cell type, making them incredibly useful for tissue repair and regeneration. Additionally, cloning techniques such as somatic cell nuclear transfer enable the creation of genetically identical cells or even whole organisms. In addition to their regenerative potential, stem cells are essential in drug development and disease modeling. Therapeutic cloning also presents a promising solution to the persistent shortage of transplantable organs. Still, these advancements come with significant ethical and regulatory challenges. Ongoing debates about the moral status of embryonic stem cells, the dangers linked to cloning, and concerns over possible unintended outcomes continue to influence public policy and research standards. As scientists and governments strive to promote innovation responsibly, it becomes increasingly important to explore how regulations adapt to support ethical progress in the field.

Vascularized stem cell-derived organoids represent a significant advancement in regenerative medicine, offering new possibilities for disease modeling and therapeutic applications. Inagaki et al. (2025) demonstrate how vascularization enhances retinal organoid development by improving oxygen and nutrient diffusion, overcoming a major limitation of traditional organoids. Their findings suggest that vascularized retinal organoids (vROs) could be critical in developing treatments for ophthalmic disorders. Moreover, vROs exhibited a significant reduction in size and retinal ganglion cell count under diabetic-like conditions, replicating disease progression in vitro (Inagaki et al., 2025). The study emphasizes that vascularization “may circumvent these problems because it allows oxygen and nutrients to enter the organoid core,” addressing a fundamental challenge in organoid research (Inagaki et al., 2025). These insights highlight the broader potential of vascularized stem cells in regenerative medicine, particularly in creating functional, transplantable tissues. Vascularized stem cell-based organoids could be applied to treating conditions such as cardiovascular disease, neurodegeneration, and organ failure. Enhancing organoid complexity through vascularization may also improve the accuracy of preclinical drug testing by providing more realistic disease models. This advancement could accelerate the development of targeted therapies while reducing reliance on animal testing. 

Cloning through somatic-cell nuclear transfer (SCNT) represents a major breakthrough in stem cell research, offering new possibilities for regenerative medicine and disease treatment modeling. Mummery and Roelen (2013) explore how human embryonic stem cells (hESCs) can be generated using SCNT while highlighting key ethical considerations in comparison to induced pluripotent stem cells (iPSCs). The authors suggest that embryonic stem cells produced through SCNT may have superior regenerative capabilities compared to iPSCs, making them a promising avenue for developing personalized treatments. Notably, they emphasize that SCNT-derived stem cells could be used to create genetically identical tissues, potentially reducing immune rejection in transplantation (Mummery & Roelen, 2013). The study also explains the genetic implications of SCNT, explaining that “apart from the nucleus, mitochondria are the only organelles that contain DNA, which encodes around ten genes,” underscoring the biological complexity of cloning (Mummery & Roelen, 2013). This distinction is important in determining the viability of SCNT-derived cells for therapeutic applications, as mitochondrial differences could still influence cell function. By comparing SCNT with iPSC technology, the authors provide a balanced discussion on the scientific and ethical dimensions of cloning in stem cell research. Beyond regenerative medicine, these advancements may also enhance the accuracy of disease models, allowing researchers to better understand conditions at the cellular level. As cloning techniques continue to evolve, their role in biomedical applications will depend on scientific progress and ongoing ethical debates, shaping the future of personalized medicine and tissue engineering.

Advancements in stem cell cloning techniques are essential for improving regenerative medicine, disease modeling, and gene editing. Li et al. (2022) introduce a microfluidics-based cell sorting method combined with the CEPT small-molecule cocktail, which enhances the viability and genetic stability of human pluripotent stem cells (hPSCs) while minimizing cellular stress. This innovation addresses key challenges in hPSC research, such as cell-line variability, investigator bias, and significant cell loss during passaging. By improving cell viability, researchers can generate more consistent experimental outcomes, which is critical for both clinical applications and basic research. Reducing investigator bias through automated sorting also increases reproducibility across studies. Furthermore, minimizing cell loss ensures that fewer resources are needed to maintain cultures, making research more efficient and accessible.

By refining the cloning process, the study provides a cost-efficient and scalable solution that facilitates the development of genetically stable clonal cell lines, making gene editing more accessible and reliable. As the authors note, “the relative ease, scalability and robustness of this workflow should boost gene editing in hPSCs and leverage a wide range of applications, including cell line development” (Li et al., 2022). The ability to generate reliable hPSC lines is critical for advancing stem cell therapies, particularly in applications requiring precision, such as patient-specific treatments and engineered tissues. Moreover, the study describes how standardizing chemically defined protocols ensures reproducibility and safety in therapeutic applications, stating “Here we describe a chemically defined protocol for robust single-cell cloning using microfluidics-based cell sorting in combination with the CEPT small-molecule cocktail” (Li et al., 2022). These technological advancements align with broader efforts to optimize stem cell-based therapies by abating the technical and financial barriers that have historically limited progress in the field. Similar to the developments in somatic-cell nuclear transfer (SCNT) cloning discussed by Mummery and Roelen (2013), this research highlights the ongoing development of stem cell technologies to improve therapeutic outcomes. As single-cell cloning techniques continue to improve, their integration into biomedical research could play a crucial role in shaping the future of regenerative medicine.

Cloning through somatic-cell nuclear transfer (SCNT) continues to be a significant area of stem cell research, offering potential advantages over induced pluripotent stem cells (iPSCs) in terms of stability and genetic similarity to natural embryonic stem cells. Gura (2013) examines the work of Shoukhrat Mitalipov and his team at the Oregon Health & Science University, who successfully cloned human embryonic stem cells using SCNT. Their findings suggest that SCNT-derived embryonic stem cells may be more stable and genetically similar to natural ES cells compared to iPSCs, supporting the potential superiority of SCNT in regenerative applications. As the study explains, “SCNT cells carried nuclear DNA identical to that of the fetal skin cells, but also mitochondrial DNA shared by the egg donor,” confirming the successful transfer of the nucleus into an enucleated donor egg (Gura, 2013). 

However, despite these promising results, the research remains hindered by regulations and financial constraints, particularly from institutions such as the California Institute for Regenerative Medicine and the National Institutes of Health (Gura, 2013). The high cost and tight regulations surrounding SCNT highlight the broader ethical and financial challenges that continue to shape stem cell research. Mitalipov himself acknowledges these hurdles, noting that “using nuclear transfer to produce ES cells is far more costly and more tightly regulated than creating iPS cells” (Gura, 2013). These challenges parallel those discussed by Mummery and Roelen (2013), who also compare SCNT-derived stem cells to iPSCs, raising ethical concerns about embryo destruction and cloning regulations. Furthermore, this research aligns with Li et al. (2022), who emphasize the importance of improving stem cell cloning techniques to enhance efficiency and reduce costs. As SCNT research evolves, overcoming these scientific, financial, and regulatory barriers will be essential for its broader application in regenerative medicine, disease modeling, and personalized treatments.

The exploration of stem cell cloning technologies reveals both significant scientific advancements and ethical challenges that are pivotal in shaping the future of regenerative medicine, disease modeling, and therapeutic applications. Studies such as those by Inagaki et al. (2025), Li et al. (2022), and Gura (2013) demonstrate the potential of these technologies to improve stem cell viability, stability, and adaptability, offering solutions for degenerative diseases, organ regeneration, and drug testing. However, ethical concerns, including the use of embryos and the high cost of research, continue to pose significant barriers to their broader implementation. This research emphasizes the importance of establishing regulatory frameworks to ensure these technologies are used responsibly by examining both the scientific progress and these ethical debates. Stem cell cloning shows vast potential for addressing critical issues such as organ transplant shortages and personalized medicine, but overcoming the financial and regulatory hurdles is essential for their clinical application. Ultimately, the continued refinement of stem cell cloning techniques could reshape the landscape of medical treatments, offering hope for a wide range of diseases and conditions.

References

Gura, T. (2013). Cell biology: Does cloning produce better embryonic stem cells? Science, 340(6139), 1390. https://pubmed.ncbi.nlm.nih.gov/23788774/

Inagaki, S., Nakamura, S., Kuse, Y., Aoshima, K., Funato, M., Shimazawa, M., & Hara, H. (2025). Establishment of vascularized human retinal organoids from induced pluripotent stem cells. Stem Cells. Advance online publication. https://doi.org/10.1093/stmcls/sxae093

Li, Y., Guo, X., Tang, K., & Liu, C. (2022). Efficient and safe single-cell cloning of human pluripotent stem cells using microfluidics-based cell sorting. Nature Protocols. Advance online publication. https://pubmed.ncbi.nlm.nih.gov/36261632/

Mummery, C. L., & Roelen, B. A. J. (2013). Cloning human embryos. Nature, 498(7453), 174–175. https://doi.org/10.1038/498174a

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