Regenerative Medicine Will Need a Reset of Outcome Measures

Image Credit: Singularity Hub 

Authors: Gordon Slater| Tandose Sambo 

“If you have health, you probably will be happy, and if you have health and happiness, you have all the wealth you need, even if it is not all you want.” – Elbert Hubbard

Regenerative Medicine is an evolving multi-disciplinary field that enables healing therapies to be incorporated into the body with the intention to enable the body to heal itself. The field is advancing at an exponential pace, and coupled with the opportunities are various inherent challenges that must be overcome. This summary outlines the highlights of the field, as well as the ethical issues that are faced by the researchers and practitioners respectively. 

As stem cell therapies and regenerative medicines are becoming more mainstream, the clinical adaptation of these therapies is not advancing as rapidly as anticipated. These reservations are influenced by the fact that some of the therapies are still to be scientifically validated in terms of their efficacy. With novel approaches to healing that are improving a patient’s health in areas such as genetic ailments, there are still some gaps to be filled where the expectations of regenerative medicine are concerned. The primary areas to be addressed in the acceptance of regenerative therapies are in the process of improving scientific methods, improving funding for research, understanding healing mechanisms for improved treatments, and the legalization of treatments so that standards are established in medical practice. Medical Science still has room for improvement and the journey is just beginning. 

What’s the core of Regenerative Medicine?

Regenerative Medicine is a multi-disciplinary field that has a multitude of focuses that ultimately aim to replace, restore and repair the normal bodily functions via the body’s healing mechanisms. The healing is administered via the introduction of live cells into the body either as clusters of identical cells or incorporated into specially designed materials that are then inserted into the body and integrated into the system. 

Within the current spheres of technology, there’s always been a forecast of what’s to come. Regenerative Medicine is a concept that is centuries in existence as a thought. It has materialized in the current realm via the advent of technology. Greek mythology has actually predicted that tissue regeneration will be a reality in our lifespans. The concept was early identified in living organisms such as newts and starfish, that have the ability to regenerate limbs. Within a two month period, the organisms are able to replenish their organs to their full capacity. 

After having witnessed other organisms regenerate limbs, man did ponder if it was possible to actually regenerate parts of his body. Regenerative medicine emerged to the present day as solid organ transplantation and stem cell therapy. Transplants of organs and even bone marrow are medical techniques that have existed for decades. Current medicine has evolved to a state where fully functioning organs can be rebuilt from cells. As these technologies evolve self replacement via transplantation will be possible. The body will accept its own cells, and the success rate of such procedures will be improved. The repair mechanism will be via exogenous cell therapy, and regeneration will be via stem cell incorporation. 

The Building Blocks of Regenerative Medicine

As regenerative medicine has evolved, there have been a variety of cell types that are utilized in therapeutic practices. Bioengineering and stem cell therapies are gearing up to be next generation therapies that will be utilized in order to heal certain orthopaedic ailments. When it comes to existing treatments, conditions such as arthritis are currently being treated via the utilization of stem cells and growth factors. Bone is now being integrated with materials generated in a material science lab, that actually match its physical properties and can also grow and expand. Transplant medicine is benefiting from the fact that via certain critical biological procedures, new organs or even veins can be grown for an individual, and implanted into the body in order to integrate with the existing mechanism. 

Stem cell therapy as a regenerative medicine, is also emerging as a means to heal the body. The stem cells are those parts of our bodies that are able to create new cells as needed by the body. With time, our stem cell count diminishes. Via external injections however, healing can be restored to a site. In the regenerative realm, researchers are studying how stem cells can be used to replace, repair, reprogram and even renew diseased cells. When healthy cells abound, the appropriate mechanisms of healing will follow. 

As undifferentiated, yet intelligent cells, stem cells have the amazing ability to grow and develop into the cells the body needs for a healing mechanism. The sources of these stem cells vary from sites such as a placenta (embryonic stem cells), garnered from a labor and delivery exercise, to adult stem cells that are extracted from places like the fat of the body, and genetically reprogrammed to the desired purpose. The latter stem cells are known as induced pluripotent stem cells. Regardless of the source, studies have shown an improvement in healing time of patients who have utilized these therapies. The current challenge in medicine is identifying the appropriate healing mechanism, and the ability to specify the differentiating ability of the stem cells. The current medical studies are aiming to identify how reprogrammed stem cells specifically generate specialized stem cells that are able to repair cells in healing sites such as the heart, foot and ankle and also in the nervous system. Via these critical analyses, the root causes of many of our current ailments can be identified and even prevented. 

Cell Expansion 

The process of growing cell cultures is one that is being improved. The process is one that is often time consuming and labour intensive. The 2D process of growing cells is riddled with challenges that are countered by the 3D approach. With the advent of bioreactors it is now possible to have cohesive, organized, perfused and functional tissue grown. These systems are able to facilitate the critical incubation parameters that are able to sustain cell growth. These include nutrient supply, oxygen and the removal of critical waste metabolites. The systems also regulate pH via suitable buffer environments and an appropriate environment that will incorporate mechanical stresses and stimulate the growth of the extracellular matrix. Bioreactors will be able to facilitate the growth and maturation of tissues. 

How Regenerative Medicine Can Optimize Medical Practice 

Regenerative medicine is the future of medicine, and will be one of the impactors, along with Healthcare 4.0, that will revolutionize the way that medicine is delivered. As a treatment that is expected to solve an issue at its root cause and result in healthy function and organs, without the need for drugs or surgery. Conventional patient therapy is likely to last a long time, while regenerative medicine is aiming to heal forever. With initially high start up costs, the results will justify the initial expenditure. As the therapy proves itself, economies of scale will enable the treatment to be expected to be more economical and benefit than traditional medicine. For aging populations, regenerative medicines will be key to improvements in quality of life as longevity is expected to increase with time. 

Biomaterials will be carriers of future biologic agents. These materials made of a variety of organic and inorganic materials will be the vehicles for the delivery of our future therapies. As material science evolves engineered materials with nano-modified structure for appropriate cell growth and improved mechanical properties will be developed. The qualities of materials such as bioavailable scaffolds include: biocompatibility, biodegradable and  non-toxic. 

Clinical Applications

As worldwide research in the field unfolds, several trials are underway to enable the transition of regenerative medicine from the bench top to the clinical practice. As tissue engineering evolves, it is now possible to transfer manufactured bladders, tracheas and even other body parts into patients. These parts were initially seeded with mesenchymal stem cells, and as a result the cells differentiated and facilitated cell growth to the new organs. Stem cell predictability is still being understood, and for this reason, many doctors are still reluctant to incorporate them into the healing therapies. The general consensus is that cytokine release and growth factors are enhancing their propagation. On going research will enable the true mechanisms to be elucidated. 

Conclusions

Surgery and drug therapy have long been established for clinical practice. As regenerative medicines are better understood, the practice will be to transition from more traditional methods to current therapies that will be sustained by the body’s own healing mechanisms. As better understanding of therapies is gleaned, it will be possible for patients to be treated within their own bodies, without the need for excessive external intervention. As the regulatory landscape is evolving, the regulatory bodies such as the FDA will actually consider stem cell therapy in their treatment plans for patients. Within the medical realm, current medical curricula will have to be adjusted to include regenerative medicine as an option. 

Reference Articles: 

[1] Regenerative medicine. Opportunities and challenges: a brief overview: https://royalsocietypublishing.org/doi/10.1098/rsif.2010.0362.focus

[2] Stanford Stem Cell PhD Program: https://med.stanford.edu/stemcell/phd/opportunities.html

[3] Ethical Issues in Regenerative Medicine: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=1380162#:~:text=Most%20of%20the%20attention%20to,human%20embryonic%20stem%20cells%2C%20and

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Dr. Gordon Slater

Dr. Slater is one of the first foot and ankle surgeons in Australia to adopt minimally invasive surgical techniques. He routinely uses MIS to treat a range of conditions, including bunions.

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Dr Gordon Slater is a highly-skilled surgeon specialising in foot and ankle conditions and sports injuries. Dr Slater is one of the first foot and ankle surgeons in Australia to adopt minimally invasive surgical techniques. He routinely uses MIS to treat a range of conditions, including bunions. MIS  has many advantages including shorter operating times, reduced post-operative pain, reduced risk of infection, minimal scarring and better cosmetic outcomes.

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