May 27, 2020

The Niche

Knoepfler lab stem cell blog

My thoughts on the Moriguchi iPS cell transplant case: what it means for patients, Harvard, scientists, and Japan

My phone has been ringing off the hook and my email flowing at an even faster rate than usual over this still breaking story of the reported transplant of iPS cells into human patients by a Japanese scientist who at some point was a visiting scientist at Harvard, apparently no more recently than 12 years ago.

The story is confusing and seems to be rapidly changing by the hour.

The fundamental question that remains is did Dr. Moriguchi transplant iPS cells into patients or not?

I don’t have an answer to that, but either way to me it seems like the stem cell field loses.

If the cells were really transplanted into patients, first of all we have to be concerned about the patients possibly developing tumors in the future. Also, were the patients properly consented as to risks before the transplant? Where did the transplants take place and was a physician involved? Was there any IRB approval or FDA regulatory oversight? The consequences for the stem cell field could be substantial from a possibly unauthorized stem cell human experiment in this hypothetical scenario.

If the cells were not transplanted into patients (which is my hope given safety concerns, etc), then it would seem the poster at the NY Stem Cell Foundation meeting was inaccurate. The now handful of articles in one of Japan’s leading newspaper in turn may not be correct. In this scenario it seems that some negative repercussions may occur for stem cell research that could slow translation of legitimate, vetted therapies to the clinic. The newspaper, the Daily Yomiuri, one of the biggest in all of Japan, continues to run with this story on the Internet, having posted several updates during the last few hours and every one leads with “Harvard team….” even though there is no evidence Moriguchi is part of any Harvard team at present. If this story turns out to be untrue, the newspaper is going to have to do some serious damage control for reporting that seems to lack depth and fact-checking. I’m not so worried about the impact on the newspaper.

I do not know what this case means for Harvard, but understandably they cannot be happy. At this point I see no evidence that Harvard did anything wrong whatsoever, but that doesn’t mean there won’t be some fallout for them from this, which is really unjust and likely to be hurtful to many people. I don’t know if now that MIT has also been named as involved whether this story could impact them as well. I would encourage Harvard to put out a statement ASAP on this.

I do not see this story as having a direct impact on Shinya Yamanaka, but it is definitely not good news for Japan. I do believe Yamanaka’s Nobel Prize was well-deserved and his research will continue to make a real difference for the world moving forward. Still, he too is likely to be very upset about this case and how it might impact people’s perceptions about iPS cells and Japanese science.

Another worry I have for the stem cell field more generally is that this case could embolden stem cell snake oil salespeople and others to resist regulatory rules and push unvetted treatments.

Bottom line. In the end the people who will suffer the most from all of this are likely to to be patients who will have to wait longer for real, properly vetted stem cell treatments to reach them.

It’s a befuddling day for the stem cell field. Hang onto your hat as I’m not sure it’s going to get any clearer or more positive in the next 24 hours.

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