It seems like just yesterday I was blogging about how concerned I was that iPS cells might be used in early phase human clinical trials as early as next year and that would be high risk given safety concerns about iPS cells.
Yomiuri Shimbun, one of the top newspapers in all of Japan, today reported on its front page (both online and in print (see below)) that iPS cells were apparently transplanted into 6 human patients at Harvard beginning early in 2012 as a heart disease treatment.
This is a surprising headline.
The newspaper article (which is in Japanese), was summarized in English by colleague Doug Sipp as follows:
Headline: “iPS-derived heart muscle transplanted into patients”
- It was learned on October 10 that a Japanese clinical researcher named Hisashi Moriguchi working at Harvard University has transplanted iPSC-derived heart muscle cells in a world first. The pace of clinical development is moving unexpectedly quickly.
- The first case was 8 months ago, and that patient is already out of the hospital. The patient was a man in his thirties who had received a liver transplant, and subsequently required treatment for ischemic cardiomyopathy.
- The study received interim approval from the Harvard IRB
- The autologous iPSCs were generated from cells obtained by biopsy, using a different reprogramming method than the original Yamanaka method.
- The study will be reported at a meeting in the US on October 10, 11.
- Safety testing was done in pigs in advance.
- Moriguchi states that there were no adverse events in the 6 cases.
I’ve emailed Dr. Moriguchi directly to ask for info on the situation and am working to obtain more information to try to independently verify and hopefully clarify this story further.