Balkan Journal of Medical Genetics

STEM CELLS NEWS UPDATE: A PERSONAL PERSPECTIVE
Wong SC
*Corresponding Author: Shiu C. Wong, Ph.D., M.B.A., Stem Cell Link, Hong Lok Building, Block M, 1st Floor, 96 Chik Fuk Street, Tai Wai, New Territories, Hong Kong, Special Administration Region, People’s Republic of China; Tel.: +852-677-22933; E-mail: scwong555@gmail.com
page: 7

SUMMARY REMARKS

From the news reports in the past 2 years, we learn that the search for the Holy Grail of Regeneration Medicine, i.e., the creation of whole working organs, is moving forward at full speed. What medical scientists have been able to achieve with decellularized ‘scaffolds’ and ‘spray-on’ stem cells is amazing. Moreover, the recent Nature “Reprogramming in vivo” article from Spain ]21[ may indeed have a strong impact on ‘organ replacement’ soon. Similar to my 2011 Commentary [1], I wish to conclude this article with a few words on the issue of ‘government laws and regulations.’ It is true that there are still countries that need to impose better regulation on unproven stem cell treatments carried out by unscrupulous individuals. Fortunately, there are countries in which their government agencies are working hard to establish laws and restrictions to regulate such unproven stem cell therapies. First, the US is an example. In 2008, the US Food and Drug Administration (FDA) began investigating Regenerative Sciences Inc. in Broomfield, CO for treating orthopedic problems using the company’s stem cell product called ‘Regenexx’ [41]. In July 2012, after 4 years of investigation and legal argument (United States of America vs. Regenerative Sciences), a US Federal Court ruled that the ‘stem cell culture product is a drug,’ since the stem cells extracted from the patient’s own bone marrow were more than minimally manipulated using reagents that were transported across state lines [42]. As mentioned in my 2011 Commentary [1], the stem cell businesses in China were described as ‘Stem Cell China. Wild East or Scientific Feast.’ It sounded good that in January 2012, the Chinese Ministry of Health announced “All medical research and clinical practices of stem cell therapy without approval from the ministry and the State Food and Drug Administration will be put to an end after the overhaul.” However, this 2012 Health Ministry announcement has fallen on deaf ears. It was thus reassuring that in March 2013, the Chinese Ministry of Health (MOH) and the State Food and Drug Administration (SFDA) issued a joint announcement, detailing the draft regulations and requirements for drug and stem cell clinical trials and indicating non compliant centers would face severe penalties [43]. At this time, l can report that the Chinese MOH and SFDA’s crackdown on unapproved stem cell centers seems to be working. I have learned that a few stem cell centers have indeed completely stopped their operations in China since the early part of 2013. The above regulatory news from the US and China is encouraging. However, a word of caution is worth repeating. In view of the increasing interest in ‘stem cell tourism’ and the huge profits from marketing ‘stem cell therapy,’ I suppose unproven stem cell therapies will continue in countries where regulations are less stringent. I sincerely hope that I do not have to hear more news about patients who have died from such unproven treatments! Finally, I wish to end this article on a high note with one more inspirational story. A recent Los Angeles television news and video in August 2013, reported the happy and emotional first-time meeting between a Stem Cell Donor (a young German woman living in Dresden, Germany) and a Stem Cell Recipient (an American woman living in Orange County, CA) 2 years after the PBSC from the former had saved the latter from leukemia [44]. I sincerely hope that stories like this will inspire more individuals to register as stem cell donors to “Save A Life Someday!”

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