Harold C., Jr. “Baylor’s Contribution to Thoracic Surgery and Cardiac Stem Cell Therapy for Heart Failure.” Proceedings of Baylor University Medical Center, v.21/1 (January 2008).
Beike Biotechnology
Beike Biotechnology
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Beike Biotechnology
Beike Biotechnology (full name: Shenzhen Beike Biotechnology Co., Ltd.), a Chinese biotechnology company, was founded in July 2005 by Xiang Hu, with funding from Peking University, the Hong Kong University of Science and Technology, and Shenzhen City Hall. The company specializes in research, clinical translation, and technology support services for adult stem cells, and does not work with human embryonic stem cells (hESC). Beike Biotechnology’s mission, according to its website, is “to be the world leader in stem cell research and clinical translation, to make comprehensive cellular therapy accessible and cost-effective, and to improve each patient’s quality of life.”
Beike Biotechnology has 450 employees, with subsidiaries located in China and India: Jiangsu Beike, Anhul Beike, Guizhou Beike, Henan Beike, Liaoning Beike, Beike (Hong Kong) International, and Beike (India) International. In addition, Beike Biotechnology has research and development centers located in Taizhou (Jiangsu Province, China) and Shenzhen (Guangdon Province, China): the Taizhou center focuses on production and storage of adult stem cells, while the Shenzhen center focuses on basic research in induced pluripotent stem cell (iPS) technology, clinical and pre-clinical studies, and the production, registration, and industrialization of adult stem cells. The Taizhou center, located within China Medical City (an area within Taizhou, which is home to many companies working in the pharmaceutical and medical materials industry), includes China’s largest international stem cell bank and first comprehensive regenerative medicine technology center.
The company’s current leadership includes Xiang Hu, chairman of the board; Shu Jian, vice president of Beike Biotechnology and member of the Shenzhen Science & Technology Expert Committee; and Tao Li, director of research and development and chief scientist of Beike Biotechnology’s induced pluripotent stem cell (iPS) project.
Research and International Cooperation
Beike Biotechnology is involved in numerous national research alliances, with partners including Huazhong University of Science and Technology; Sun Yat-Sen University in Guangzhou, China; Shenzhen Graduate School of Tsinghua University; Zhengzhou University; Wu Zu Ze Science and Technology Foundation; and the PLA Navy General Hospital.
China is a pioneer in offering stem cell treatments for medical conditions, and Beike Biotechnology is a key supplier of adult stem cells for such treatments. In fact, the company provides stem cells and clinical research support to over 70 medical institutions in China, southeast Asia, the Middle East, and Europe. These stem cells are derived from healthy donors, and samples are screened for disease both by Beike’s labs and by blood banks appointed by the government. Beike Biotechnology has worked with about 20 Chinese and international companies to negotiate standards for different aspects of stem cell technology and clinical research, is involved in a cooperative research and development project with the American company BetaStem Therapeutics, and is (as of April 2014) the only Chinese company to be a member of the International Society for Cellular Therapy.
Safety and Efficacy of Adult Stem Cell Treatments
China is a pioneer in using adult stem cells to treat many diseases, including multiple sclerosis, autism, refractory systemic lupus erythematosus, hereditary ataxis, cirrhosis of the liver, and burns. Many of the procedures that use adult stem cells to treat these diseases have not been subject to the types of clinical trials required in the United States or western Europe to demonstrate safety and effectiveness, but people from all over the world have traveled to China to receive them because they are not available elsewhere.
To help guide patients in evaluating stem cell therapies, and to further inform them about the process by which clinical therapies should be tested for safety and efficacy, the International Society for Stem Cell Research produced the Patient Handbook on Stem Cell Therapies. Because Beike Biotechnical is a leading supplier of adult stem cells, the company is often named in articles cautioning medical tourists (those who travel to a foreign country specifically to receive medical treatment) against spending their money, and perhaps risking their health, on unproven treatments.
In response to criticism about the lax regulation of stem cell therapies, the Chinese Ministry of Health has begun making an effort to regulate such treatments more closely. As of May 1, 2009, new regulations issued by the Chinese Ministry of Health categorized all stem cell therapies as “category 3” technologies, a classification that also includes gene therapy, sex change operations, and surgical procedures to treat drug addiction and mental illness. Category 3 technologies are directly regulated by the Ministry of Health, because they are considered “ethically problematic,” “high risk,” and/or “still in need of clinical verification,” according David Cyanoski, in a 2009 article in Nature. In addition, the ministry began requiring institutions to demonstrate the safety and efficacy of stem cell treatments through clinical trials before offering them to the public.
Beike Biotechnology was affected by these new regulations, because it not only provides stem cells to a network of clinics but also acts as a first point of contact for patients seeking stem cell treatment. For instance, Cyanoski quotes two Beike Biological representatives who said that they provided care and clinical consultations to patients in the hospital. This practice raises red flags in the eyes of some American medical directors, who argue that representatives of the company providing a treatment (stem cells in this cases, but the same principal would apply to pharmaceuticals) should not interact directly with patients. Cyanoski also notes that Beike did not respond to requests for information about success rates, clinical trials, and other questions about the effectiveness of the treatments offered by the company.
Carolyn Brown, writing in the Canadian Medical Association Journal in 2012, notes that many Canadians continue to travel to foreign countries, including China, for stem cell treatments whose effectiveness has not been proven and that might be unsafe. Brown also notes that, although China has imposed tougher regulations requiring that treatments be proven safe and effective, many clinics continue offering treatments that have not been widely accepted as effective. Brown cites Beike Biotechnology as a major provider of stem cell therapies for many conditions for which it is not approved in Canada, and also notes that most Chinese companies providing stem cell treatments are careful to not guarantee results for their treatments.
Sarah E. Boslaugh
Kennesaw State University
See Also: Adult Stem Cells: Overview; China; Clinical Trials (Adult Cells), Ethics of; International Society for Stem Cell Research; Unapproved Therapy, Ethics of.
Further Readings
Beike Biotech: Clinical Translation. http://beikebiotech.com/index.php/clinical-translation/overview (Accessed April 2014).
Brown, Carolyn. “Stem Cell Tourism Poses Risks.” Canadian Medical Association Journal, v.184/2 (February 7, 2012). http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3273527 (Accessed April 2014).
Cyanoski,
