Engineering the future: The intersection of TERM and precision medicine in modern healthcare

Tissue engineering and regenerative medicine (TERM), integral to the evolution of precision medicine, are making strides in regenerating or repairing damaged tissues and organs. Tissue engineering uses cells, scaffolds, and growth factors to regenerate or replace damaged or diseased tissues, while regenerative medicine combines tissue engineering with other treatments like gene therapy, immunomodulation and cell-based therapy to induce tissue regeneration within the body. When combined with precision medicine's tailored approach, TERM holds immense promise for addressing some of the biggest modern healthcare issues, such as the urgent demand for organ replacements amidst an ageing population. 

While challenges such as technical complexities and ethical concerns persist, ongoing advancements are gradually integrating TERM into precision medicine frameworks, offering personalised healthcare solutions for organ and tissue repair. This blog gives a brief introduction to TERM in the context of precision medicine, the challenges currently faced in the sector and what the future holds for this discipline of medicine.

Stem cells

Stem cells are unique cells capable of transforming into various types of cells in the body and have the potential to repair or replace damaged tissues. Under the right conditions in the body or a laboratory, stem cells divide to form more cells called daughter cells. These daughter cells can become new stem cells or specialised cells, such as blood cells, brain cells, heart muscle cells or bone cells. 

At the moment, researchers are using stem cell studies to:

• Increase our understanding of disease: By understanding how stem cells mature into specialised cells and grow into organs, researchers can better understand how diseases develop.
• Test new drugs: Before trialling new medicines on human participants, researchers can use stem cells to test drugs for safety and effectiveness. For example, nerve cells can be created to test a new drug for a nerve disease.
• Regenerative medicine: Because stem cells can be guided into becoming specific cells, they can be used in people to regenerate and repair tissues that have been damaged or affected by disease.

Due to their pluripotency, differentiation, and self-regeneration properties, stem cells have become important for the treatment of a wide variety of conditions, including Alzheimer’s disease, Parkinson’s disease, spinal cord injuries, and osteoarthritis. 

Another common example of stem cell regenerative medicine is bone marrow transplants. In these transplants, doctors use stem cells to replace cells in bone marrow which have been damaged by chemotherapy or disease. These cells are often adult stem cells or taken from umbilical cord blood. They can also be used to support the donor's immune system to fight some types of cancer and blood-related diseases, such as leukaemia, lymphoma, neuroblastoma and multiple myeloma. 

Stem cell therapy is also being used to repair diseased, dysfunctional, or injured tissues. To do this, researchers grow stem cells in a lab and then manipulate them to develop into the specific type of cell needed by the patient. From here, the specialised cells can be implanted into a person. For example, a person with heart disease would receive heart cells into the heart muscle. With these transplanted cells, the heart could then have what it needs to repair itself. At the moment, researchers have already shown that adult bone marrow cells guided to become heart-like cells can repair heart tissue, but more research is being done before this treatment becomes available.

Tissue engineering

Tissue engineering evolved from the field of biomaterials development. It involves using scaffolds, cells, and biologically active molecules and combining them into functional tissues. The main aim of tissue engineering is to create cells, organs or systems that can restore, maintain, or improve damaged tissues or whole organs. There are already a few types of engineered tissues that are approved by the FDA, including artificial skin and cartilage, however they have limited use in human patients.

Tissue engineering plays a relatively small role in patient treatment at the moment. Supplemental bladders, small arteries, skin grafts, cartilage, and even a full trachea have been implanted in patients, but the procedures are still experimental and very costly. In the lab, there have been successful examples of complex organ tissues like heart, lung, and liver tissue being recreated. However, we're currently still a long way from being able to implant these into a patient. While that is a goal for the future, these tissues are still very useful in drug development and research. By using lab-grown organs and tissues, researchers can screen drug candidates, help create more personalised medicines, reduce the number of animals used in research, and lower the risk to human participants too.

Precision medicine applications

The applications of Tissue Engineering and Regenerative Medicine (TERM) within the realm of precision medicine represent a significant leap towards highly personalised healthcare solutions. By integrating the unique capabilities of TERM with the tailored approach of precision medicine, this innovative field offers the potential for developing personalised tissue and organ replacements. These replacements are engineered from a patient’s own cells, which is a strategy designed to minimise rejection and enhance recovery. For instance, in addressing degenerative diseases, TERM methodologies enable the creation of specific cell types or tissues that have been lost or damaged, thereby providing targeted therapies. These therapies are meticulously tailored to each patient's specific condition, ensuring that treatments are as effective and as individualised as possible.

Moreover, the power of TERM extends into the creation of organoids and tissue models derived from patient cells, which serve as groundbreaking tools for drug testing and disease modelling. This aspect of TERM is invaluable in precision medicine, as it allows for the identification of the most effective treatments with minimal side effects on an individual basis. The capability to mimic the complex structure and function of real tissues in a controlled environment enables researchers and clinicians to predict how different treatments will work in the specific genetic context of a patient. As a result, TERM is not only pioneering new paths in regenerative medicine but also fortifying the foundation of precision medicine. Through these applications, TERM is actively contributing to a shift in healthcare towards more personalised, effective, and timely interventions, promising a future where treatments are not just based on the diagnosis but also on the unique genetic makeup and circumstances of each individual.

Challenges

Using precision medicine with TERM brings to light a range of challenges that span technical, ethical, regulatory, and financial domains, reflecting the complexity and novelty of these approaches in healthcare.

Scientific and technical challenges

• Individual variation in tissue response: A significant challenge is the variability in how individuals’ tissues respond to engineered products, requiring personalised approaches not just at the genetic level but also in the bioengineering of tissues.
• Compatibility and integration: Ensuring that bioengineered tissues or organs are fully compatible with the patient’s body and can integrate seamlessly, functionally, and immunologically within diverse genetic backgrounds is complex and requires a deep understanding of both genetics and tissue engineering.

Ethical and regulatory challenges

• Ethical concerns with genetic data: Precision medicine’s reliance on detailed genetic information raises ethical questions about privacy and consent, which are compounded when this information is used to design personalised TERM solutions.
• Regulatory pathways: Personalised tissue-engineered products must meet safety and efficacy standards, necessitating flexible yet rigorous regulatory frameworks to accommodate the bespoke nature of these therapies.

Economic and accessibility challenges

• Cost of TERM therapies: The development, manufacturing, and clinical implementation of personalised TERM solutions are inherently costly, raising concerns about the affordability and equitable access to these advanced treatments.
• Reimbursement models: Traditional healthcare reimbursement models are ill-equipped to handle the high costs and personalised nature of TERM therapie, challenging their broader adoption and implementation.

Implementation and scalability challenges

• Clinical translation: Translating personalised TERM innovations from bench to bedside involves overcoming significant scientific and logistical hurdles, including proving efficacy across varied genetic profiles and ensuring scalable manufacturing processes.
• Infrastructure for personalised therapies: The infrastructure required to support the widespread adoption of personalised TERM solutions—ranging from genetic sequencing facilities to specialised biomanufacturing units—is substantial and not yet fully established.

Addressing these challenges requires a multidisciplinary effort, involving not only scientific and medical advancements but also ethical deliberation, regulatory innovation, and strategies to ensure equitable access to these cutting-edge healthcare solutions.

Conclusion

The intersection of TERM and precision medicine represents a significant advancement towards addressing complex healthcare challenges, such as organ replacement and the treatment of degenerative diseases. As we navigate the technical, ethical, regulatory, and financial challenges, the future of healthcare looks increasingly personalised and effective. By continuing to integrate TERM's innovative approaches with the tailored care models of precision medicine, we are moving towards a future where treatments are not only based on a patient's diagnosis but also their unique genetic makeup, offering a more nuanced and effective approach to healing and recovery.