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Defying Western Science, Chinese Biotech Pursues Untested Stem Cell Therapy

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Although Beike Biotechnology’s promising stem cell treatment is unproven, patients are paying to receive the treatment in China.

Pursuing a controversial medical procedure that shows great promise but hasn’t been validated by clinical trials, a Chinese company is using stem cells to treat patients, many of them from the West, who have diseases previously thought incurable.The company, Beike Biotechnology, hosted the first China Stem Cell Technology Forum in late July.

Beike uses nonembryonic stem cells to treat a variety of ailments including heart disease and neurological disorders such as cerebral palsy, spinal cord injury, muscular dystrophy, and optic nerve hypoplasia, a primary cause of blindness in children. Its technology, which hasn’t been subjected to double-blind clinical trials of the sort required by the U.S. Food and Drug Administration, uses a combination of umbilical cord cells and stem cells derived from the patient being treated. Beike is based in Shenzhen, in southeastern Guangdong Province.

Beike was founded in July 2005 with funding from Beijing University, Hong Kong University of Science and Technology, and Shenzhen City Hall. The Mandarin-language forum was attended by over 300 stem cell biologists and researchers, including several scientists based in the United States. It was described in a report in ChinaBio Today, an online newsletter that covers the biotechnology industry in China.

Unlike most countries of the West, China lacks rigorous government oversight of testing and clinical trials required before a drug or medical procedure is used on human patients.

Along with the umbilical cord cells it uses to treat patients, Beike is researching induced pluripotent stem cells (iPS cells), which are derived from cell reprogramming technologies and can be frozen and stored for later use in medical treatment. First produced in 2006 from mouse cells and in 2007 from human cells, iPS cells are considered a noncontroversial potential alternative to embryonic stem cells. A symposium on iPS cells was held in conjunction with the Stem Cell Technology Forum.

“Leading scientists in China are constantly finding ways to create more effective iPS cells,” said Dr. Hu Jifan, a senior research scientist at the Palo Alto VA Health Care System in California, in a statement released by Beike. Collaboration among researchers, added Hu, “may someday create the conditions for effective clinical treatments and industrial-scale production of iPS cells.”

While Beike’s research on iPS cells is supported by some Western scientists, its decision to begin treating patients, who pay upward of $20,000 for a series of injections of stem cells, has raised questions among stem cell researchers.

One prospective patient is Brandon Stewart, a 7-year-old visually impaired resident of Calhan, Colo., near Colorado Springs. The boy suffers from optic nerve hypoplasia, and his parents have held a series of fundraisers to generate the $75,000 they estimate it will cost to transport him to Shenzhen for treatment. Brandon and his family plan to leave for China on Aug. 8.

Editor’s note: This story was updated Aug. 6 to make clear that Beike is researching iPS cells and not using them in any treatments.

By Richard Martin, InformationWeek

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