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Saturday, Oct. 13, 2012
Doubt cast on clinical stem cell tests
Harvard says it never authorized studies by Japanese man claiming major research advance
Harvard University said neither it nor Massachusetts General Hospital have ever authorized any iPS-related clinical studies by Hisashi Moriguchi, who claims to have achieved the first clinical application using the revolutionary stem cell technology.
"No clinical trials related to Moriguchi's work have been approved by institutional review boards at either Harvard University or Massachusetts General Hospital," a statement issued by Harvard and related institutes said Thursday.
The statement confirmed that Moriguchi "was a visiting fellow at Massachusetts General Hospital from 1999-2000," but added that he "has not been associated with (the institution) or Harvard since that time."
Moriguchi, a researcher at University of Tokyo Hospital, claimed to be a visiting lecturer at Harvard and to have conducted clinical trials at Massachusetts General Hospital with other researchers to transplant artificial cardiac muscle cells developed from iPS cells into six patients with heart disease.
The claim came just after Shinya Yamanaka of Kyoto University and a British scholar were jointly awarded this year's Nobel Prize in physiology or medicine for their research on iPS cells. Yamanaka and John Gurdon were credited with the discovery that mature human cells can be reprogrammed as immature cells capable of developing into all types of body parts.
"Research has been conducted after going through due procedures, such as consultations with a university ethics committee," Moriguchi claimed. "I have been told my method of creating iPS cells is different from the one used by Yamanaka (and Gurdon), but I have been doing it my way and no problems have been identified after transplants."
Moriguchi, who is thought to have asked a heart surgeon to carry out cell transplants, unveiled details about the treatment at a meeting of annual stem-cell research conference at Rockefeller University in New York held Wednesday and Thursday.
But the event's organizer, the nonprofit New York Stem Cell Foundation, subsequently said it "has received information from Harvard University that raises legitimate questions concerning a poster presentation" by Moriguchi, and has withdrawn it from the conference.
Moriguchi graduated from Tokyo Medical and Dental University with a degree in nursing science and does not have a license to practice medicine, according to a professor who taught him as an undergraduate.
Treating heart disease is said to pose the biggest challenge in clinical studies using stem cells. Experts say it will take several years at the earliest before clinical trials on human patients with heart problems can begin.