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"STER" Science and Cardiothoracic Surgery: an Asian Perspective

Canada

One of the most exciting scientific advances with great clinical promise in the dawn of the 21^st century is the advent of STER science and medicine. The term "STER" science is my new acronym for the increasingly intertwined fields of Stem cell, Tissue Engineering, and Regenerative sciences, which are currently undergoing vigorous laboratory studies and early clinical trials. In the field of cardiothoracic surgery, they may lead to new therapeutic approaches, such as: stem cell implantation to repair damaged myocardium and improve cardiac function, a procedure known as cellular cardiomyoplasty; tissue-engineered cardiac valves and conduits constructed using autologous cells populated on biodegradable scaffolds, which will require neither anticoagulation therapy nor repeated replacements to adapt to the growing infant or child recipient; and regeneration of tissues and organs such as the limbs and heart.^1–3 The rapid proliferation of new scientific societies, research laboratories, institutes, and companies engaged in the development of STER science in the last several years has been truly mind-boggling. Numerous new scientific journals and papers as well as clinical trial reports are pouring out, again reflecting the amazing advance and interest in STER science and medicine. In this tidal wave of excitement, a question that may be raised here is: can the developing countries of Asia participate and even lead this revolutionary development in science and patient care in the coming years?

The rapid emergence of Asia geopolitically and economically in recent years indicates that scientists and clinicians in Asian countries will indeed have the potential to play increasingly important roles in such advances. Japanese scientists are already displaying their leadership, exemplified by the recent creation of the amazing iPPC (induced pluripotent progenitor cells), in which fully differentiated cells, such as skin fibroblasts, were induced to de-differentiate back to become pluripotent stem cells.⁴ Clinically, this implies that we will be able to produce any kind of differentiated cell needed to treat a patient, by modifying his own cells such that they will be immunologically tolerated without rejection. Thus it is theoretically possible to create new heart muscle using cells taken from a patient’s skin, to replace damaged myocardium. Someday, we may even be able to modify a patient’s own cell to create a whole heart as a donor organ for himself, thus overcoming immune rejection and solving the problem of donor heart shortage for transplantation; a revolutionary vision hard to even imagine at present.

A number of smaller Asian countries, such as South Korea and Singapore, are already devoting much effort to develop expertise, actively contributing to STER sciences. In Taiwan’s Stem Cell Research Center, where I serve on its advisory committee, I witnessed the isolation of pluripotent stem cells from human placenta, an organ routinely discarded following childbirth.⁵ The logistic and ethical advantages of using such a stem cell source are obvious. In the 2 giant nations of Asia, China and India, institutions and research groups are also being established to pursue developments in this field^6,7 In view of the vast human resources available, increasingly significant contributions from these countries can be expected in the years to come.

In contrast to the scientific efforts discussed above, however, the rush to clinical application of STER sciences in Asia is showing a mixed picture. As an example, let us look at cellular cardiomyoplasty procedures for myocardial infarction and heart failure. In Western countries, this procedure is considered experimental, requiring rigorous review of the protocols for clinical trials, which have to be approval by ethics and safety committees prior to trials on patients. Such a trial progresses stepwise from phase I to phase III, so that the risk is minimized while scientifically rigorous results are acquired. Properly designed clinical trials are mandatory before a new procedure can be ethically and legally accepted for regular patient care. To date, many such trials on cellular cardiomyoplasty have been carried out worldwide, but this procedure has not been fully accepted as an established therapy.⁸ Nevertheless, in many Asian countries, such requirements for rigorous clinical trials prior to acceptance as routine therapy has not been firmly established and followed. Thus there are worldwide internet advertisements for various stem cell treatments in Asia, touting anecdotal cases without statistical validity to attract patients. In the past couple of years, I had opportunities to participate in 2 excellent international conferences on cardiac stem cell therapy; one in 2006 in Bangkok, Thailand, and another in Chennai, India in 2007. The sponsoring institutions, Bangkok Heart Hospital and Frontier Lifeline Heart Center, are both world-class, led by well-recognized cardiac surgeons, Kitipan Visudharom and KM Cherian, respectively. These scientific conferences supplemented clinical programs in which patients were recruited both locally and internationally. The facilities available and the quality of services offered at these institutions are excellent. However, at present, this effort appears to be a part of what is known in the West as medical tourism, in which patients travel to distant foreign countries to obtain medical or surgical therapies not available in their own countries, either for financial or regulatory reasons. Because of this, it is logistically nearly impossible to carry out scientifically valid clinical trials on these patients, with properly randomized controls, appropriate sample size, and follow-up.

Even though good efforts have been made in a number of countries to carry out such randomized clinical studies, they are mostly single-institute trials with limited sample size and statistical power. Thus collaborative multicenter trials with input and encouragement from established and respected multinational organizations in the region might be desirable. The Association of Thoracic and Cardiovascular Surgeons of Asia and the Asian Society for Cardiovascular Surgery, as well as this journal, Asian Cardiovascular and Thoracic Annals, have effectively promoted advances in cardiothoracic surgery in Asia in recent years. Their concerted efforts may further advance such cutting-edge research in Asia, and play leadership roles in its clinical application in cardiovascular and thoracic surgery.

REFERENCES

1. Chiu RCJ, Wang JS. Cellular cardiomyoplasty. In: Kipshidze NN, Serruys PW, editors. Handbook of cardiovascular cell transplantation. London: Martin Dunitz, 2004:15–30.

2. Sutherland FWH, Mayer JE Jr. Tissue engineering for cardiac surgery. In: Cohn LH, Edmunds LH Jr, editors. Cardiac surgery in the adult. New York: McGraw-Hill, 2003:1527–36.

3. Kühn B, del Monte F, Hajjar RJ, Chang YS, Lebeche D, Arab S, et al. Periostin induces proliferation of differentiated cardiomyocytes and promotes cardiac repair. Nat Med 2007;13: 962–9.[Medline]

4. Okita K, Ichisaka T, Yamanaka S. Generation of germline-competent induced pluripotent stem cells. Nature 2007;448:313–7.[Medline]

5. Chang CJ, Yen ML, Chen YC, Chien CC, Huang HI, Bai CH, et al. Placenta-derived multipotent cells exhibit immunosuppressive properties that are enhanced in the presence of interferon-gamma. Stem Cells 2006;24:2466–77.[Medline]

6. Murray F, Spar D. Bit player or powerhouse? China and stem-cell research. N Engl J Med 2006;355:1191–4.[Free Full Text]

7. Stem cell research in India. CellNEWS. Available at: http://www.geocities.com/giantfideli/CellNEWS_Stem_Cells_India.html. Accessed April 21, 2008.

8. Trials of the heart. The Scientist. Available at: http://www.the-scientist.com/supplementary/html/24104. Accessed April 21, 2008.

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