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Medical advances have significantly improved human living conditions. Pharmaceutical products such as drugs, antibiotics, vaccines and the remarkable improvements in medicine and surgery provide effective treatments and defence against a vast number of diseases. However, the rapid progress in technology and the understanding of human biology have also led to the emergence of controversial innovations.
Regenerative medicine is one of the newest and most fascinating fields in medical science. Enormous investment is poured in with the hope for fruitful results. Promising outcomes of the research suggest the huge medical potential and the positive impacts on the economy and health care system. However, the opponents are concerned about the technical obstacles and ethical issues that may arise in the development of regenerative medicine. Critics worldwide thus question: should regenerative medicine be encouraged?
The aim of the report is to provide an overview of regenerative medicine and discuss the negative and positive impacts on social, economic and medical level.
THE SCOPE OF REGENERATIVE MEDICINE
Regenerative medicine focuses on the replacement and regeneration of tissues or organs. Moving beyond the scope of traditional transplantation, it is the intersection of various technological approaches including gene therapy, stem cell transplantation and tissue engineering (Greenwood et al, 2008). Its core lies in the manipulation of cells, the smallest independent unit of life that can be cultured under appropriate conditions. The type of cells used in regenerative medicine is stem cell, unspecialized cells that can divide and differentiate into specialized cells such as muscle cells, nerve cells, etc. Stem cells can be derived from embryos or adult bone marrow (Kochar, 2004).
The process of bio-engineering an organ or tissue consists of four main steps: (1) isolation and (2) expansion of cells in culture, (3) assembling the cells in maturation system and (4) transplantation (Kemp, 2006, p. 660). Firstly, the cells are extracted from the patient and cultured in a nutrient-rich soup containing essential molecules required for cell's growth and division. Next, the soup is coated on a 3-dimensional artificial scaffold designed to degrade once implanted into the patient. The scaffold provides the framework for the cells to grow on. The final construction is placed in a bio-reactor which mimics the conditions inside the human body, including the temperature, pH and pressure. During this process, the cells further multiply and mature to form a functional organ or tissue ready to be implanted. Biomaterials, growth factors and other substances are used to stimulate cell division and ensure the cells grow in the right direction (Atala, 2010).
Figure 1. The process of bio-engineering a heart Organengineerheartlg.jpg
Source: Yen-Chih Huang in Regenerative Medicine, 2007
The aim of regenerative medicine is to fully restore the loss or impairment of tissues or organs (Greenwood et al, 2006). If successful, this technology can expand the human's potential to regenerate: worn out tissues and organs can be replaced, wounds healed without scarring. Such promising outcomes easily cause hype in the media and unrealistic public expectations (Mason, Dunnil, 2009). Although research in this field has given hope to millions of dying patients, the truth is it takes time to create products that can be approved to use in humans and deliver to the market (Powers, 2006). Currently, regenerative medicine research is still in its early stage. Most products are in trials; ones that work are struggling to find a place in the enormous pharmaceutical market. Some initial products failed to work properly when implanted into the patients. For example, Apligraf did not function as a living skin but a mere wound stimulant (Kemp, 2006). However, despite early failures, regenerative medicine has been making steady progress (Mason, 2007). Professor Yacoub states: "It is an ambitious project but not impossible. If you want me to guess I'd say 10 years. But experience has shown that the progress that is happening nowadays makes it possible to achieve milestones in a shorter time. I wouldn't be surprised if it was some day sooner than we think." (Jha, 2007, p. 1). Recent breakthroughs in regenerative medicine include the successful transplantation of a bio-engineered trachea (wind pipe) into a 30-year-old woman with collapsed airways (Scientific Blogging, 2008). The operation, carried out by Professor Paolo Macchiarini from the University of Barcelona, involved extraction of stem cells from the patient's bone marrow and expansion of these cells into a large population. A donor trachea was decellularized leaving only the cartilage of the trachea intact. The patient's cells were grown on the donor trachea in a bio-reactor. This results in a new trachea made of the patient own cell, which was used to replace the impaired bronchus in the patient. Bio-engineered bladders have also been grown using a similar method by Dr. Anthony Atala at Wake Forest Institution (a three dimensional collagen scaffold is used instead of a decelluarized cartilage) and successfully implanted into patients (Johnson, 2009). His research team is also working on growing other organs, including heart, kidney, blood vessels and solid body parts (e.g. ears, fingers, limbs) with promising outcomes (Atala, 2010).
THE DISADVANTAGES OF REGENERATIVE MEDICINE
Cost is the major barrier to the development of regenerative medicine. Because the cost of cell-based product development and clinical trials is very high, it is undeniable that enormous investment, both from the public and private sectors, is crucial to the continuity of the research (Kemp, 2006). Contracts with a large amount of funding have increased in the past few years as private companies are on the race for this potentially profitable technology (Mason, Dunnill, 2008). However, according to Gary Pisano, "despite the commercial success of companies such as Amgen (Thousands Oak, CA, USA) and Genentech (South San Francisco, CA, USA) and the stunning growth in the revenues for the industry as a whole, most biotechnology firms earn no profit." (Pisano, 2006, p. 12). Investment in regenerative medicine is risky and may result in loss of profits. Thus, the cost of regenerative medicine is be considered justified by many (Mason, Dunnill, 2008)
This innovation can also cause a number of negative social impacts. According to Aubrey de Grey, the success of regenerative medicine means that people will have the chance to replace and regenerate their impaired organs, thus leading to the increase in worldwide life expectancy (Saenz, 2010). This may contribute to the expansion of population which can exceed the Earth's resource and cause negative consequences, such as loss of jobs due to the surplus of workers, pollution and food crisis. Secondly, the fact that most of the research funding comes from the private sector controls the direction of the research (Kemp, 2006). The risk of regenerative medicine being commercialized for the wrong purposes is possible. Without consistent legal framework and strict regulation, human greed for profits and the desire for longer life span can lead to inappropriate use of regenerative medicine's products (King et al, 2009).
In addition, regenerative medicine can be inefficient. Many technical problems are yet to be solved: some early products underperformed and failed to work properly once implanted (Kemp, 2006). The complexity of organs with three-dimensional structure made of various different cells (e.g. heart valves) is highly challenging compared to skins, blood vessels and bladders (Liszewki, 2006). There is also great difficulty in commercializing regenerative medicine products because of their short off-the-shelf life span. Furthermore, due to the variety of nucleotide sequences in DNA of individuals, specific cells must be taken from each patient with scaffolds of appropriate size to make sure the risk of rejection is minimized (Atala, 2010). Thus, large-scale manufacture of regenerative medicine products can be difficult.
THE ADVANTAGES OF REGENERATIVE MEDICINE
There are three main reasons why regenerative medicine should be encouraged. Firstly, it can provide positive impacts on public health by providing treatments to a variety of disease, including Alzheimer's disease (the degradation of nerve cells), diabetes, spinal cord injury, arthritis (joint inflammation), Parkinson's disease, diabetes and chronic diseases (Atala, 2010). It can also address congenital abnormalities in children where "the normal function of an organ is initially absent" (Mawson, Dunnil, 2008, p. 3). If successful, regenerative medicine can replace traditional organ transplantation which, despite remarkable improvements, is not the best treatment. Patients have to live on immunosuppressant drugs continuously after the transplant to prevent the body cells from attacking the foreign tissues or organs (Travers, 2001). This may pose risks of cancer or other diseases as the immune system is weakened enabling pathogens (e.g. bacteria, virus) and cancerous cells to infect the patient. Regenerative medicine is thus considered a more effective option. Because the cells are extracted from the patient, the risk of rejection and the use of immunosuppressant drugs are significantly minimized (Jha, 2010).
Secondly, the severe shortage of organ donor is another reason why regenerative medicine should be promoted (National Institute of Health, 2006). According to the World Health Organization, "15 million people died of cardiovascular disease in 2005; by 2010, it is estimated that 600,000 people around the world will need replacement heart valves." (Jha, 2008, p. 1). Clearly, the current demand for donor organs far exceeds the supply. Millions of patients worldwide have died or are suffering from diseases that can be treated by replacement of impaired organs (Kemp, 2006). Even in some cases where organs are available, operations still cannot be carried out because the recipient's body does not biologically accept the donor's organ (Fishman, Rubin, 1998). In addition, this shortage also leads to illegal organ trading on an international level (Shimazono, 2007). The World Health Organization states that there has been a significant increase in kidney trafficking in the past few years pushing the number of illegal kidneys to 15000 each year. Regenerative medicine can be an effective solution to the inadequate supply of donor organs, thus decreasing illegal organ trading (Scientific blogging, 2008).
Thirdly, the success of this technology can be beneficial to the economy. Regenerative medicine's potentials to reform health care system, especially aged care, means that the Government can reduce the budget spending on medical purposes, which can be used on other sectors such as education (Mawson, Dunnill, 2008) . Although the initial investment of regenerative medicine is high, the cost of immunosuppressant drugs, examination and multiple operations are expected to be lower compared to organ transplantation, which can be profitable in the long run (Pittsburgh Tissue Engineering Initiative, 2010). Furthermore, the development of regenerative medicine creates jobs and the establishment of local regenerative medicine healthcare institutions. This can attract a large number of medical tourists, thus potentially boosting the local economy (Kemp, 2006).
Recent progress in regenerative medicine has caused enormous public concern. The opponents of regenerative medicine propose that it is expensive and inefficient compared to traditional organ transplantation. Negative social impact is also a reason why regenerative medicine research should not be encouraged. However, this innovation can benefit the society with its potential to address a variety of incurable diseases, solve the problem of organ shortage and boost the economy by reducing treatment costs and promoting medical tourism.
Despite the enormous benefits, the problems associated with the development of regenerative medicine must be confronted before further research is carried out. Cautious approach should be taken to ensure ethical codes are not breached and to keep the field's rapid development under control. There is also the need to establish a global legal framework to prevent the risks of companies and individuals taking advantage of this innovation.