Regenerative medicine is a branch of medical science focused on repairing, replacing or regenerating damaged or diseased cells, tissues or organs to restore normal function.
The emerging interdisciplinary field combines biology, engineering and clinical practices to create innovative therapies aimed at repairing or replacing damaged tissues and organs.
Unlike traditional treatments that aim to manage symptoms, regenerative medicine seeks to address the root cause of a condition by deploying the body’s own repair mechanisms or by introducing new, healthy cells to work with the body.
Cell therapy
Cell therapy involves using living cells to repair or replace damaged tissues. For example, stem cells, which have the potential to become many different types of cells, are often used in regenerative medicine.
Stem cells are the body's raw materials – cells from which all other cells with specialised functions are generated. Under the right conditions, stem cells can divide and form more cells called daughter cells.
These daughter cells either become new stem cells (self-renewal) or specialised cells (differentiation) with a more specific function, such as blood cells, brain cells, heart muscle cells or bone cells.
In regenerative medicine, stem cells are often harvested from the patient’s own body (autologous therapy) or from donors (allogeneic therapy).
These cells can be injected into the damaged area, where they can grow and replace the lost or injured tissue.
Australian biotech Orthocell Ltd (ASX:OCC, OTC:ORHHF) is working on autologous tendon therapy, an injectable cellular therapy designed to treat chronic tendon injuries.
It’s a non-surgical solution currently in clinical development, with more than 1,000 patients treated so far.
The therapy uses the patient’s own healthy tendon-derived cells to promote the regeneration of the damaged tendon to reduce pain and return function.
Tissue engineering involves scientists creating scaffolds made of biomaterials that can be implanted into the body.
These scaffolds provide a structure where new cells can grow and form tissue.
Sometimes, these scaffolds are seeded with cells before being implanted or they may be designed to attract the body’s own cells to start the repair process.
Gene therapy, often a partner discipline to regenerative medicine, involves modifying or introducing genes into a patient’s cells to treat or prevent disease.
In the context of regenerative medicine, gene therapy can be used to correct defective genes that are causing disease or to introduce new genes that help cells to function better or regenerate.
Biomaterials
These are natural or synthetic materials that are designed to interact with biological systems.
In regenerative medicine, biomaterials are used to create scaffolds or as part of implants that can support tissue regeneration or act as delivery systems for cells or drugs.
Bioprinting is a cutting-edge technology that uses 3D printing techniques to create these complex tissue structures layer by layer.
Bioprinting uses bioinks – materials composed of living cells and other biological molecules – to print tissues with a high degree of precision.
Clinical applications
The discipline holds the key to curative treatments that restore function and improve the quality of life for patients with various conditions, with potential applications across a wide range of medical fields, including orthopaedics – repairing bones and joints, cardiology – regenerating heart tissue after a heart attack, neurology – treating spinal cord injuries, and dermatology – healing burns or chronic wounds.
One of the most well-known examples is the development of lab-grown skin for patients with severe burns.
For conditions like macular degeneration or corneal damage, regenerative medicine offers the potential to restore vision by regenerating or replacing damaged eye tissues.
In genetic disorders like cystic fibrosis, gene therapy can be used to deliver a correct copy of the defective gene to the patient’s lung cells, potentially restoring normal lung function.
Gene therapy can also be used to modify stem cells to make them more effective in repairing damaged tissues.
Chronic wounds, such as diabetic ulcers, are a major healthcare challenge. Regenerative therapies aim to accelerate healing by using stem cells, growth factors, or engineered tissues to promote tissue regeneration and reduce scarring.
And scientists are working towards the goal of growing entire organs in the lab for transplantation.
This could revolutionise organ transplants, addressing the shortage of donor organs and reducing the risk of transplant rejection.
Ethics and regulation
The field of regenerative medicine raises some important ethical and regulatory questions.
The use of embryonic stem cells has been a topic of ethical debate, particularly in the US, because it involves the destruction of early-stage embryos.
The development of induced pluripotent stem cells (iPSCs) has provided an alternative that bypasses this sensitive debate.
Another issue is regulation. Regenerative therapies often fall under the jurisdiction of regulatory bodies like the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA), which ensure that these therapies are safe and effective before they are approved for widespread human use.
The regulatory process for regenerative medicine products can be complex and lengthy, reflecting the need to thoroughly assess the risks and benefits of these novel therapies.
That said, for those companies moving through the system, the considerable benefits to humanity and the vast need these treatments will meet provide quite the incentive.