Stem cell news bites: microbiota, clinic doc death, Stem Cells Inc, & more

This edition of our stem cell news bites finds a number of notable stem cell news items.

A potentially cool link between gut stem cells and microbiota is reported by Tae-Hee Kim of the Ontario Institute for Regenerative Medicine. See the nifty image of the stem cells from Dr. Kim showing proliferating gut cells in green in roughly the same location where the stem cells find their home.The work mentioned relates to necrotizing enterocolitis. Note that this article mentions only mouse work so implications in humans are unclear and I could not find an associated publication so we’ll have to stay tuned to see the meaning of this development.

gut stem cells microbiota

Dr. Tae-Hee Kim research image

Will formerly near death stem cell biotech Stem Cells Inc. ($STEM) be regenerated following its acquisition by another firm? This stem cell news has generated a lot of attention including this headline: “StemCells Inc picked up by Israeli medical devices firm.” What will $STEM shareholders get out of this? What is Microbot Medical exactly?

Stem cell clinic chain Cell Surgical Network has reported in the News section of the apparent death of a doctor who formerly was a member of that network, Dr. Steven Gitt. Dr. Gitt offered stem cell interventions via Phoenix Stem Cell Treatment Center. I was not able to find an obituary for Dr. Gitt, although his practice North Valley Plastic Surgery mentions a funeral held a few weeks ago. My condolences go out to his family.

More stem cell news on a happier note, noted stem cell researcher George Daley is the new Dean of Harvard Medical School.

I need to learn more about this other merger: Ireland’s Mallinckrodt buys US regenerative medicine firm. The firm in question is Stratatech…not one I’m familiar with.

What news on stem cells caught your eye?

Did NBC News Err On Key Part of Their Stem Cell Report?

Steven Gitt Nancy SnydermanNBC News did a big on-line story and even a NBC Nightly News Segment on dubious stem cell therapies on Friday.

Normally a national news story on the problem of the mushrooming stem cell clinics selling unapproved “treatments” would be a positive development, but this otherwise very nicely done story might have a major error that could confuse millions of viewers.

The NBC story by Anna Schecter and Stacey Naggiar is entitled “Costly, Unproven Stem Cell Therapy for Neurological Disorders Questioned”. It focused on Cell Surgical Network, a franchising chain of stem cell clinics selling non-FDA approved, fat-based stem cell interventions  for a host of conditions. For background see my interview with the leaders of Cell Surgical Network and another post on my concerns about their operations.

Overall this was a very well-done, balanced NBC report, but a key part of this story was a bombshell claim by NBC that the FDA does not regulate these stem cell “treatments”. This seems frankly very difficult to believe.

So in an otherwise fine report, did NBC make a major mistake on the FDA or did the FDA make a major tidal policy change to weaken its own regulation of stem cells without telling anyone else? That latter possibility sure doesn’t sound like something that the FDA would do.

I have emailed Schecter to ask for clarification and a potential correction of this part of their story if appropriate. Schecter had talked quite a bit with me when preparing the story. I indicated that the adipose stem cell preparations of Cell Surgical Network were from my perspective almost certainly to be viewed by the FDA as more than minimally manipulated. I also stressed that the FDA does indeed by all accounts regulate these therapies and every bit of recent FDA guidance would suggest no recent change.

For example, the FDA just issued new guidance in the last few weeks that is consistent with their continued regulation of these stem cell treatments. I also just this week posted my interview with the FDA in which they indicated in their own words no apparent change in policy. So it sure would seem the FDA is in fact regulating these stem cell “treatments” even if they are going about it more slowly than many of us would wish.

Still, at the end of the NBC stem cell story video, NBC News Chief Medical Correspondent Dr. Nancy Snyderman unambiguously says that the FDA told NBC News that it does not regulate these stem cell “treatments”.  You can see an image above from NBC of Snyderman interviewing Dr. Steven Gitt, a physician member of the Cell Surgical Network with a clinic in Phoenix.

Also in the written NBC story, it says:

“Under FDA guidelines, the procedure used by Berman and Gitt is not regulated because the cells are “minimally manipulated,” aren’t combined with other genetic material and the patient gets only his or her cells re-injected.”

So did the FDA just do a complete U-turn on regulation of stem cells or did NBC err in this key part of their story?