The University of Southampton

Author: Emilie Last

Patients vs. Patents: Is DNA a Corporate Asset or Human Right

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Imagine having the ability to “pick and mix” genetic traits – eye color, disease resistance, height maybe even intelligence. CRISPR gene editing means this isn’t just science fiction;  it’s becoming science reality! Acting like a molecular toolkit to produce ‘designer babies’ offering the potential to select or modify traits before birth. If we can customize human life, who gets access?

What Got Me Interested in CRISPR

I became interested in CRISPR after reading about legal battles between major research institutions and ethical tensions between innovation and accessibility. Critically, this topic shows the intersection of cutting-edge technology and human rights. During research I was struck by the rapid progression from laboratory research to clinical trials and how tightly the therapeutic potential is limited through patents. It raised difficult ethical questions and concerns: should these technologies be monopolized or are they a global good?

Figure 1. Image showing the mechanism of the CRISPR-cas9 enzyme (BioRad, 2021)

What is CRISPR-Cas9?

CRISPR-Cas9 is a genome editing system derived from the bacterial immune response. It functions as a precise, RNA guided tool for editing genes in living organisms (Doudna & Charpentier, 2014). Cas9 facilitates highly specific and precise genomic modifications by creating double-stranded breaks at targeted DNA sequences, directed by a strand of guide RNA. These breaks are repaired through homology-directed repair (HDR) or non-homologous end joining (NHEJ), these introduce small mutations (Barrangou & Doudna, 2016).

Who owns CRISPR?

One of the most intriguing controversies surrounding CRISPR isn’t scientific—it’s legal! Both the University of California and the Broad Institute contested ownership of the technology. Ultimately, the Broad Institute was awarded key patents. Critical examination shows a troubling dynamic; these exclusive patents restrict access and increase costs, limiting freedom of research (Correa & Hilty, 2022).

Figure 2, Timeline of the CRISPR CAS-9 patent dispute (Aquino-Jarquin, 2022)

Continued research led me to question whether patents hinder CRISPRs medical potential. Patents are widely regarded as incentives for innovation; however, they often prevent widespread accessibility to lifesaving treatments (Mir et al., 2022). Consequently, medical technology ownership through patents prioritizes profit over patient access. I considered open innovation and open-source models as ways to reduce patent exclusivity (Mali, 2020). This led me to pose the question: Should medical treatment be owned by a few or shared for the common good?

Figure 3. Shows the complex network of CRISPR-Cas9 intellectual property ownership, applications and licensing (RodrĂ­guez FernĂĄndez, 2018).

Is it Ethical?

Gene editing offers remarkable possibilities but also raises challenging and uncomfortable questions. Core issues consent, accessibility and the potential societal impact. Genetic editing poses a risk for off-target mutations which are likely irreversible and raise significant concerns about human health and ecological stability in the long term (Evans, 2021).

Personally, researching these risks altered my perspective. Despite the exciting potential, I became concerned about unintended consequences. Irreversible changes impact entire ecosystems or human health across generations. I also confronted issues such as autonomy and distributive justice.

The National Academies in the US have approved germline editing for serious diseases in situations where it is safe and informed by parental consent. However, this may push technology closer towards practices such as eugenic enhancement. Germline editing brings forwards the issue of consent. Prompting me to question whether it is ethically justifiable to make permanent genetic decisions for individuals who are unable to give their consent (Waters, 2000).

The future of CRISPR

Researching this topic altered me to the balance between innovation and ethical responsibility. I concluded that achieving the full potential medical benefit of requires global collaboration and transparent regulatory frameworks. CRISPR could easily become a privilege reserved only for the affluent. Initiatives like patent pools can promote broader and affordable access, important for low and middle income countries. Flexible licensing models such as non-exclusive and humanitarian use licenses. Ultimately, I do not believe that CRISPRs success will be solely scientific but in the ethical, responsible and equitable deployment of this technology.

Bibliography

Aquino-Jarquin, Guillermo. ‘Early “Reduction to Practice” of the CRISPR–Cas9 Invention in Eukaryotic Cells’. Frontiers in Genetics 13 (4 October 2022). https://doi.org/10.3389/fgene.2022.1009688.

Barrangou, Rodolphe, and Jennifer A. Doudna. ‘Applications of CRISPR Technologies in Research and Beyond’. Nature Biotechnology 34, no. 9 (September 2016): 933–41. https://doi.org/10.1038/nbt.3659Bio-Rad. ‘How CRISPR Revolutionized Science’. Accessed 25 March 2025. https://www.bio-rad-antibodies.com/blog/how-crispr-revolutionized-science.html.


Correa, Carlos M., and Reto M. Hilty, eds. Access to Medicines and Vaccines: Implementing Flexibilities Under Intellectual Property Law. Cham: Springer International Publishing, 2022. https://doi.org/10.1007/978-3-030-83114-1.

Doudna, J. A., & CharpThe new frontier of genome engineering with CRISPR-Cas9. Science, 346(6213), 1258096. Centier, E. (2014).Evans, John H. ‘Setting Ethical Limits on Human Gene Editing after the Fall of the Somatic/Germline Barrier’. Proceedings of the National Academy of Sciences 118, no. 22 (June 2021): e2004837117. https://doi.org/10.1073/pnas.2004837117.


Mali, Franc. ‘Is the Patent System the Way Forward with the CRISPR-Cas 9 Technology?’ Science & Technology Studies 33, no. 4 (15 December 2020): 2–23. https://doi.org/10.23987/sts.70114.

Mir, Tahir Ul Gani, Atif Khurshid Wani, Nahid Akhtar, and Saurabh Shukla. ‘CRISPR/Cas9: Regulations and Challenges for Law Enforcement to Combat Its Dual-Use’. Forensic Science International 334 (May 2022): 111274. https://doi.org/10.1016/j.forsciint.2022.111274.

Bio-Rad. ‘How CRISPR Revolutionized Science’. Accessed 25 March 2025. https://www.bio-rad-antibodies.com/blog/how-crispr-revolutionized-science.html.

A New You! Stem Cells in Regenerative Medicine

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Can the body heal itself? The power of stem cells in a new era of healing

Stem Cells are cells that can self-renew and differentiate, this is crucial for the development of an organism as well as repair after injury (Mayo Clinic, no date). As a cornerstone of regenerative medicine, they offer innovative new solutions to treating diseases with limited treatment options such as restoring damaged organs and tissues (Wang et al. 2024).

Understanding Stem Cells

It is important to understand the different types of stem cell

  • Multipotent: The ability to differentiate into more than one cell type in the body
  • Pluripotent: The ability to differentiate into all of the various cell types in the body

Pluripotent and multipotent stem cells originate from different sources. Pluripotent stem cells are derived from early-stage human embryos, these are capable of dividing without differentiation and can develop into the primary three germ layers. In comparison, adult stem cells can only differentiate into the cell type of the tissue that they are found (Mayo Clinic, 2025). Researchers have developed an induced pluripotent stem cell, similar to embryonic stem cells, but, formed by transferring embryonic genes to a somatic cell (Mayo Clinic, 2025).

What is Regenerative Medicine

Regenerative medicine is a branch of medicine that focuses on healing or replacing organs and tissues damaged by factors such as disease or trauma. ‘Healing’ is achieved by replacing missing tissue structurally or functionally using stem cells such as mesenchymal stem cells induced pluripotent. This is achieved through materials as well as de novo-generated cells. It is also possible to leverage the body’s inate healing response, however humans lack regenerative capacity (Mao and Mooney, 2015). Regenerative medicine has the potential to treat neurodegenerative diseases as well as heart failure, for example.

Stem Cells in Regenerative Medicine

Adult stem cells such as mesenchymal and induced pluripotent stem cells (iPSCs) , exhibit multilineage differentiation capacities as well as immunomodulatory properties (Li, Luanpitpong, and Kheolamai, 2022). There have been successful treatments using these stem cells for bone and cartilage regeneration as well as spinal cord injuries and diabetes (Hoang et al., 2022). allowing them to differentiate into required tissues and treat injuries, inflammation, and age-related disorders through regeneration of muscle, cartilage, and muscle regeneration. Human pluripotent stem cells (hPSCs), embryonic stem cells (ESCs), and (iPSCs) can differentiate into any cell type so have a very high potential (Wang et al., 2024).

Challenges Associated

However, there remain risks associated with stem cell use such as a heightened risk of tumor formation, and immune rejection, and it’s not guaranteed that the cells will survive post-translation.

The treatments with the most therapeutic potential use embryonic stem cells, due to their pluripotency. However, the obtainment of ESCs is controversial due to the destruction of human embryos, many people object to religious and ethic principles (Margiana et al., 2022). Stem cell therapies also have a high cost meaning availability is restricted to wealthier patients (Hoang et al., 2022).

Conclusion

The advancement of regenerative medicine presents exciting opportunities such as within genetic modification, combining stem cells with drug delivery as well as biomaterial scaffolds (Li, Luanpitpong, and Kheolamai, 2022). However, currently stem cells remain at the forefront for conditions such as cardiovascular disease and organ regeneration. However, further research is needed to combat concerns such as immune rejection and tumor risks. For this treatment to become mainstream steps will have to be taken to address high costs and accessibility issues as well as the need for a global regulatory body to monitor its use.

Bibliography

Hoang, Duc M., Phuong T. Pham, Trung Q. Bach, Anh T. L. Ngo, Quyen T. Nguyen, Trang T. K. Phan, Giang H. Nguyen, et al. ‘Stem Cell-Based Therapy for Human Diseases’. Signal Transduction and Targeted Therapy 7, no. 1 (6 August 2022): 1–41. https://doi.org/10.1038/s41392-022-01134-4.

Li, Jingting, Sudjit Luanpitpong, and Pakpoom Kheolamai. ‘Editorial: Adult Stem Cells for Regenerative Medicine: From Cell Fate to Clinical Applications’. Frontiers in Cell and Developmental Biology 10 (31 October 2022). https://doi.org/10.3389/fcell.2022.1069665.

Mao, Angelo S., and David J. Mooney. ‘Regenerative Medicine: Current Therapies and Future Directions’. Proceedings of the National Academy of Sciences 112, no. 47 (24 November 2015): 14452–59. https://doi.org/10.1073/pnas.1508520112.

Margiana, Ria, Alexander Markov, Angelina O. Zekiy, Mohammed Ubaid Hamza, Khalid A. Al-Dabbagh, Sura Hasan Al-Zubaidi, Noora M. Hameed, et al. ‘Clinical Application of Mesenchymal Stem Cell in Regenerative Medicine: A Narrative Review’. Stem Cell Research & Therapy 13, no. 1 (28 July 2022): 366. https://doi.org/10.1186/s13287-022-03054-0.

Mayo Clinic. ‘Answers to Your Questions about Stem Cell Research’. Accessed 5 March 2025. https://www.mayoclinic.org/tests-procedures/bone-marrow-transplant/in-depth/stem-cells/art-20048117.

Mayo Clinic. ‘Answers to Your Questions about Stem Cell Research’. Accessed 5 March 2025. https://www.mayoclinic.org/tests-procedures/bone-marrow-transplant/in-depth/stem-cells/art-20048117.

Wang, Jipeng, Gang Deng, Shuyi Wang, Shuang Li, Peng Song, Kun Lin, Xiaoxiang Xu, and Zuhong He. ‘Enhancing Regenerative Medicine: The Crucial Role of Stem Cell Therapy’. Frontiers in Neuroscience 18 (8 February 2024). https://doi.org/10.3389/fnins.2024.1269577.

Petri Dish to Patient : How 3D Bioprinting is Changing Transplants

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“Why can’t we just print more organs?” Overcoming the organ shortage crisis with Bioengineering

Globally, the demand for organ transplants exceeds supply. In the United States as of 2021 116,566 patients were waiting for an organ transplant, 6 564 patients died waiting for an organ. Despite this, only 41 354 transplants were performed (Kupiec-Weglinski 2022). 3D bioprinting is an emerging technology that offers a promising solution by creating bioengineered organs and tissues, reducing patients left waiting for life-saving treatments and reliance on human donors (Bose, 2023)

3D bioprinting is an innovative technology that involves printing layer by layer, combining biomaterials, bio-inks, and living cells (Panja et al., 2022). This provides an opportunity to engineer human tissues and organs for medical use such as :

  • Drug testing on human models (more reliable and reduces demand for animal models)
  • Custom implants
  • Reducing the waitlist for replacement human organs

How It Works

There are 4 main bioprinting techniques

Technique How it Works Pros Cons
Extrusion Bioprinting Uses mechanical force to push bio-ink through a nozzle Good for large tissues
Can use high-viscosity bio-inks 		Can cause damage to cells from pressure
Laser-Assisted Bioprinting Uses lasers to deposit biomaterials High precision
No nozzles needed 		Expensive, Slow
Stereolithography (SLA)Uses UV light to harden layers of biomaterials High resolution, Fast Limited material options
Inkjet Printing Droplet-basedFast, Cost effective Low precision
Can only use low-viscosity bio-inks

(Panja et al., 2022)

Applications

Recently there have been significant breakthroughs in replicating complex human organs especially hollow organs such as the lungs, heart, and digestive system. Despite the immense progress, technical challenges still persist.

Bioprinting Lungs 

  • Lung diseases such as COPD and COVID-19 have increased demand for lung transplants. The focus remains on the airways and alveoli.  Advancements have been made in the development of artificial alveolar models using inkjet printing, hydrogels, and synthetic polymers.  Despite this, these have not been applied to organ replacement yet (Panja et al., 2022). Achieving the highly complex structure and function of alveoli is still a significant hurdle. 

3D Printed Heart Tissue 

  •  A heart has been bioprinted including blood vessels. This is crucial when developing the functionality of replacement organs. This was achieved using a technology called Coaxial Sacridicial Writing in Functional Tissue. This adds layers of real blood vessels, blood supply is essential for sustaining all bioprinted organs (Brownell, L. 2024).

Digestive System 

  • Researchers have also seen developments in the bioprinting of the digestive system, including stomach, intestines and bile ducts. There is enormous potential for this to revolutionize drug testing and reduce reliance on animal models. However, barriers remain due to the inability to replicate the mechanical processes of the digestive system such as peristalsis(Panja et al., 2022. 

 

Challenges and Ethical Concerns

  • Cost: Bioprinting is an expensive technology, with significant costs from research, development, and clinical trials. As well as the extensive laboratory equipment, this means that the early technology is likely to be limited to the wealthy (Bose, P., 2023).
  • Tissue Vascularisation: functional blood vessels are imperative for delivering oxygen and nutrients, and keeping tissues alive. Functional blood vessels are challenging due to their microscopic size and complexity (Panja et al., 2022).
  • Regulation and Safety: international regulations are necessary to ensure safety, efficacy and ethics have been taken into consideration (Brownell, L. 2024).

Conclusion

3D printing has the potential to make fully functional, transplantable organs a reality. There needs to be a focus on personalization to reduce the risk of elimination. However, vascularisation will remain a significant barrier to applicability. However, the potential to remove donor waitlists and animal models.

Could we be entering an era of on-demand organ transplants?

Bibliography

Bose, P. (2023). Bioprinting Organs: A Look into the Future of Transplantation. News-Medical. Available at: https://www.news-medical.net/health/Bioprinting-Organs-A-Look-into-the-Future-of-Transplantation.aspx [04/03/25].

Brownell, L. (2024). 3D-printed blood vessels bring artificial organs closer to reality. Harvard John A. Paulson School of Engineering and Applied Sciences. Available at: https://seas.harvard.edu/news/2024/08/3d-printed-blood-vessels-bring-artificial-organs-closer-reality [04/03/25].

Panja, N., Maji, S., Choudhuri, S., Ali, K. A., & Hossain, C. M. (2022). 3D Bioprinting of Human Hollow Organs. AAPS PharmSciTech, 23(5), p.139. Available at: https://doi.org/10.1208/s12249-022-02279-9 [04/03/25].

Kupiec-Weglinski, Jerzy W. ‘Grand Challenges in Organ Transplantation’. Frontiers in Transplantation 1 (6 May 2022). https://doi.org/10.3389/frtra.2022.897679. [04/03/25]