Clinics can’t retract stem cell treatments gone bad

Stem cell facelift comicYou can stop taking a pill or an injection treatment, but you can’t stop or retract stem cell treatments if there’s a bad side effect.

Unlike other kinds of medicines, once stem cells have been transplanted into patients, if something goes wrong you cannot stop the ‘treatment’. There’s no retraction possible because transplanted stem cells spread in the body and potentially integrate.

One of the striking things in the commercial stem cell arena in 2016 was the emergence of patient lawsuits against stem cell clinics including two proposed class action suits. These patients, and I count potentially now more than a dozen, allege a variety of harms ranging from tumors to blindness. The reason I mention this is that there appears to be huge potential for harm to patients from unapproved stem cell therapies. I know a lot of patients who would wish they could undo what the stem cell clinic did. It’s just not possible.Stem cell cartoon

Even in an appropriately regulated stem cell trial context, there’s no easy way to undo stem cell transplants. There has been talk for years about suicide genes to be inserted into stem cells to provide “a net” should something go awry with stem cell treatments, but it’s not clear how well these would work and stem cell clinics aren’t interested in that anyway.

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Rick Perry’s Paid Board Position at Controversial Stem Cell Clinic Celltex

Rick Perry stem cellsIf you rewind the stem cell clock several years, the big news in the stem cell clinic arena was dominated for quite some time by a single stem cell clinic called Celltex in Texas in part because their most famous customer was Governor (at that time) Rick Perry. You can read the many past posts I’ve done on Celltex here.

Today the stem cell clinics are making news more for their sheer numbers (nearly 600 in the U.S. alone), but a few years back Celltex and Perry were stirring things up and getting noticed in large part because they were tangling with the FDA. Celltex and their former partner RNL Bio were cooking up a stem cell product that did not have FDA approval and the agency issued Celltex a warning letter. Perry was a supporter of Celltex.

Now Perry is more than just a supporter or patient of Celltex, he reportedly has a paid position on the stem cell clinic’s board. No longer governor nor running for president, perhaps Perry wants to devote more time to stem cells?

The Celltex of today remains a Texas business, but is selling stem cell treatments only (to my knowledge) administered across the border in Mexico. The change in clinical location was it seems an attempt to get outside the range of authority of the FDA. What will Perry’s actual operational role be? I don’t know. The AP got this quote:

“I’m a big believer in adult stem cells,” Perry told The Associated Press by phone Thursday. “My reputation is important to me and I want to be associated with companies I believe in.”

I actually met and talked with Governor Perry a few years back when Celltex was more on the radar screen and he was still governor. The meeting was down at Scripps in a meeting set up by Jeanne Loring. Several other physicians and scientists were present. He struck me as very excited about stem cells and eager to get businesses to move to Texas.

ABC News has this quote from Celltex on this development:

“Celltex CEO David Eller said in an emailed statement. “Given this passion, it is natural he joined the board of a premier U.S.-based biotechnology company that is known for its unparalleled adult stem cell technology now that he has left public service.”

I’m curious what the future holds for Celltex and every now and then I hear rumors of them potentially doing some treatments in the US or getting an IND from the FDA or something like that.  I did note that at least one of their patients spoke at the recent FDA stem cell meeting.

Anyone heard other news on Celltex?

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?

Patient gets cancer growing on spine from dubious stem cell treatment

A brief report in the NEJM today highlights the risks facing patients who get stem cell treatment from dubious clinics as one such patient recently developed a large spinal tumor.

Dr. Aaron L. Berkowitz and colleagues describe how this patient who received a mixture of several stem cell types from an overseas clinic was later diagnosed with a very unusual neoplastic growth on his spine.

stem cell tourism tumor

NEJM Figure 1a/b, showing massive spinal tumor (long, brighter region)

The data point to the tumor arising from the stem cell treatment as it was genetically distinct from the patient.

Oddly the cancer defied classification as a particular tumor type. This may in part be due to the fact that he was given a mix of embryonic, fetal neural, and mesenchymal stem cells. It’s unclear which cell type(s) might have led to the tumor. Notably he apparently didn’t get any immunosuppression, which raises the question of his own immune response to the transplants.

This patient received at least three transplants at different locations across the globe outside the U.S. While risks of stem cell offerings are higher in certain countries, there are many stem cell clinics here in the U.S. that sell stem cells without FDA approval and with little if any data to back them up.

The NY Times just published an article on this case and identified the patient as Jim Gass as well as providing more details including the start of the chain of events:

“I began doing research on the internet,” Mr. Gass said. He was particularly struck by the tale of the former football star and professional golfer John Brodie who had a stroke, received stem cell therapy in Russia and returned to playing golf again.

So Mr. Gass contacted a company, Stemedica, that had been involved with the clinic, and learned about a program in Kazakhstan. When Mr. Gass balked at going there, the Russian clinic referred him to a clinic in Mexico. That was the start of his odyssey.”

The impact of sports celebrities getting unapproved stem cell treatments and the press about such situations can be far and wide on the public.

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Is REGROW Act anti-embryo research? Pluripotent stem cells excluded

REGROW ActThe REGROW Act has attracted both support and criticism, including on this blog, for the changes it would mandate in the way the FDA regulates stem cell products. More specifically it would greatly reduce regulation of experimental stem cell products. I believe that would be dangerous to patients and to the stem cell field more generally.

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