Saturday, 25 August 2012


CellTex is a company offer stem cell treatments. The Celltex controversy has snowballed into a much bigger story than I ever expected it would be. This is largely thanks to the unfounded attacks of Carl Elliott and Leigh Turner, both of whom are faculty members of the Center for Bioethics at the University of Minnesota. Elliott published a detailed article of the situation in Slate, which was later retracted for being below the editorial standards of the magazine. The magazine issued a personal apology to McGee:

Editor’s Note

Slate withdraws "The Celltex Affair."

On Feb. 17, 2012, Slate published an article titled “The Celltex Affair: An Ethics Scandal Strikes the World of Bioethics.” Because of shortcomings in the editorial process, the article did not meet Slate’s standards for verification and fairness and should not have been published. We withdraw the article and apologize to Dr. Glenn McGee.

More recently, a different law firm, representing Celltex, has sent a letter to the office of the president of the University of Minnesota stating that Elliott is guilty of libel. For the record, I think that both Elliott and Turner should be lambasted by their university and the community at large for their outrageous critiques of CellTex's stem cell treatments.

Celltex supplies stem cells to at least one local physician and pays him a $500 commission for each use. It seems to me the company should be open about what it does with the cells it banks and processes, what it tells patients they can be used for, how they are described and delivered to physicians. To this end they have placed this information on-line.

And just as Celltex has done right by making a full disclosure of its practices, now that McGee has quit the companythe editor-in-chief role at AJoB, his position at the Center for Practical Bioethics, and his position on the board of directors at the ICMS, he has used his inside knowledge to help clear the air and make a valuable contribution to understanding the factors at play in this controversy. 

In summary, CellTex finds itself being attacked by academic scientists who are either trying to create a career around controversies in stem cell medicine or those like me, who write to protect the patent interests of universities (potentially worth billions). Stem cell clinics represent a competitive interest to many in the patents for dollars game. Hopefully the U Minn administration will recognize that the attacks launched by Elliott and Turner are very personal. I anticipate that  McGee will live up to his promise to provide "timely, lengthy, pointed comments on the matter."

New revelations in Grekos case

The Naples News has published dramatic new developments in the case surrounding Zannos Grekos, who has been accused by the Florida state medical board of injecting an elderly and very ill patient with stem cells in his Bonita Springs, FL clinic, despite an emergency restriction specifically prohibiting this activity that was placed on his medical license last year. In the March 19 article, the newspaper reveals that a second Lee County physician, Konstantine K. Yankopolus of Fort Myers, has also had an emergency restriction placed on his license for assisting Grekos. Yankopolus told an NBC news reporter that he considered his action in assisting Grekos in the procedure to be "humanitarian." I have not been able to find how much the patient was charged for this particular unscientific treatment, but Regenocyte has typically charged $65,000

Yankopolus unrepentant

Even more interestingly, according to the article, the medical board has alleged that Yankopolus "entered a false progress note in (the patient's) chart falsely indicating that no stem cell preparation was infused." 

Great times in stem cell land

For much of the past decade, Beike Biotechnology, a private company based Shenzhen, China was one of the most prominent stem cell centers on earth. In its early years Beike founder, Hu Xiang (a.k.a Sean Hu) teamed up with an American professional named Jon Hakim (a.k.a John Harris). Beike has reported treating more patients than almost any other stem cell clinic.

Scott Alexander Moffett (who usually goes by Alex) teamed up with Beike fresh out of a string of successful businesses in south and southeast Asia (visit his public LinkedIn page for a list of companies he has headed). He became the new head of Beike Biotech’s holding company, Beike Holdings and embarked on an impressive campaign to diversify their stem cell business outside of China. In the two and half years he was there, he helped build a network of affiliates and subsidiaries that spanned from Romania to Saudi Arabia to India to Malaysia and Indonesia.

Alex at the World Stem Cell Summit 2009. Watch the video here

But when Hu abruptly sold his stem cell company in late 2010, Moffett followed soon after, buying out the holding company and launching his own new venture, a Bangkok-based “Vanuatu corporation” called Siricell (apparently meaning “The wealth of the cell” in Sanskrit/English), which has the  mission of targeting “age related disease management and to assist in the extension of life until the Singularity Nexus expands the scope and capacities of our work in these areas.” For those of you who don’t read life extension books, the “Singularity” is a proposed future point at which technological development makes it possible to extend human lifespan radically or perhaps even indefinitely. Whether that is achieved through unforeseeable and unlikely advances in medicine, or by uploading a digitized simulacrum of one’s neural network into a computer, I for one will not be holding my breath for it to arrive. (But good luck to all the True Believers!)

And there are many true believers indeed, represented enthusiastically by the SENS (Strategies for Engineered Negligible Senescence) Foundation, an anti-aging research group headed by Aubrey de Grey, with backing from such impressive backers as PayPal co-founder and Ron Paul’s favorite sugardaddy Peter Thiel and “Internet entrepreneur” Jason Hope. (If you had hundreds of millions of dollars, as these two do, you might try to live forever too.) Interestingly, the SENS Foundation is listed on the Siricell website as a member of the advisory board.

Moffett himself is no stranger to out-of-the-box thinking. He did spend nearly 20 years, after all, at the helm of various companies in the "ayurceutics" and herbal medicine space. And, as with his most Singular stem cells, and apparently drum machine technology (see Linn Moffet Electronics) as well, his expertise was self-taught (see Education). He also spent quite some time in his youth on the luxurious compound of the Fellowship of Friends, an esoteric group in Northern California established by an elementary school teacher in the early 70s to keep the teachings of Gurdjieff and Ouspensky alive. Moffett previously listed this on his Education history, but now only this screenshot remains.

And what good friends they are!

And now, here in 2012, we find Moffett and Marshank together again in a stem cell venture, with Moffett the Founder, Chairman and CEO and “Visionary Entrepreneur” Marshank the Director of International Development. Rounding out the crew is Narin "Jimmy" Apiraichuk, the youthful former VP of Theravitae, the Bangkok-based stem cell center set up by Don Margolis. Marshank stated via LinkedIn that, “SiriCell now has subsidiaries in India, Hong Kong, Thailand, Malaysia, Philippines and the Britisch [sic] Virgin Islands. In 2011 we will be opening subsidiaries in Panama and Egypt.”

I remain convinced that Moffett and Marshank have stumbled upon the stem cell fountain of youth.

More than minimally manipulated

More than minimally manipulated is an FDA term that means that cells are processed beyond a certain point. 

While the Celltex controversy was unfolding down in Texas, the International Cellular Medicine Society (ICMS), a group dedicated to applying stringent guidelines, announced the appointment of plastic surgeon Ricardo Rodriguez as its new president. will be the third leader of this organization, which has shown a frankly astonishing ability to project its patient centric messages (and those of its previous leaders, sports medicine doctor Christopher J. Centeno, and chiropractor/epidemiologist Michael D. Freeman) in major media and across the internet. 

But what exactly is the ICMS about, how did it burst so suddenly onto the stem cell scene, who are its leaders, and what motivates them? The tale is long, so I'm afraid I'm going to need to ask a bit more of your time than usual to explain.

ICMS gets it's mail at a PO Box, like many small organizations. Also like many small non-profits without funding, it's true presence is on the internet. 

The Salem P.O. box is a convenient place for ICMS executive director, Salem-based David Audley, to pick up the mail, and just one hour by car from Oregon Health Sciences University in Portland, where former ICMS president, Michael D. Freeman (2009-2012), teaches forensic epidemiology. Freeman, originally a chiropractor, More recently, he seems to be putting this knowledge to frequent use as an expert witness in various cases, including testifying for the defense in the Casey Anthony trial, and giving lectures on "Exposing, defusing and debunking junk science" in Los Angeles this January.

I don't know what led Freeman out of chiropractic and into the arms of epidemiology, expert testimony, and his longtime partnership with Chris Centeno, owner of Regenerative Sciences (of Regenexx™ and USA v Regenerative Sciences fame), but PubMed shows their first co-authored publication to be from 2004 ("Waddell's signs revisited?"). This co-authored comment in Spine  and their next six papers have nothing to do with stem cells, but rather various forms of spinal injury, with a focus on spine trauma. For the past few years I thought this was anomalous, and not particularly worth commenting on.

But then last month I stumbled across some real expert testimony, by Dr. Muschler and Freeman, in the FDA vs Regenerative Sciences case. But for anyone interested in seeing what a barn burner of back and forth between these two experts only need to look as far as Centeno's response to this article:

Dr. Muschler established his own standard for what constitutes effective research. Unlike our procedure, where we went through two years of an IRB where we didn’t charge patients, Dr. Muchler’s competitive procedure that spawned his “Cellect Device” was used by surgeons solely based on a study in dogs (i.e. without any human use or IRB oversight). This is despite the fact that under current FDA rules, the device more than minimally manipulates a bone graft sample by allowing stem cells to attach to the sample, as its stated goal is to alter the biologic characteristics of that bone graft. After that, it was used in thousands of patients before a single human trial was performed. When that study was finally published, it wasn’t an RCT with a placebo; instead it was a comparison trial similar to the one we published on our procedure (see

Centeno and Freeman were also leaders of a separate, now-defunct organization (Spinal Injury Foundation) prior to becoming the first and second president of the ICMS, and said organization was tasked with, among other things, providing the institutional review of a body of research behind Centeno's Regenexx™ Freeman responded to the FDA's expert declarations here, and Regenerative Sciences posted a chronology here.

Freeman and Centeno: the early years
At this point in the story, I have to give credit to an anonymous friend of the blog who pointed out that the Spinal Injury Foundation itself evolved from a different website, Whiplash 101. Centeno also founded an (also now-defunct) online Journal of Whiplash and Related Disordersfor which he and Freeman, served as co-editors-in-chief.
Centeno and Freeman's Spinal Injury Foundation ran awareness days and other fundraisers including, in 2007, a chance to drive a Lamborghini, Ferrari, Bentley, or other speedmobile around a race track in the Rockies. The promotional page for the event included the cautionary text: "If you can't find a car you like, consider psychiatric help or high-dose antidepressants."

Snap your neck for whiplash!

It was in around 2005 that Centeno showed visible symptoms of the stem cell itch (his first stem cell paper was published the following year). We know this because 2005 was the year he sold the Colorado professional corporation known as "Christopher J. Centeno, M.D., P.C."  to Florida-based company PainCare Holdings for $3,250,000 in cash and 1,132,931 PainCare shares valued at $3,750,000. The PainCare deal turned rancid after that company was accused of overstating its revenues, and became subject to multiple class action suits. Centeno was able to regain his assets.

Not long after this settlement, Centeno and Freeman started the first version of the ICMS, known as the American Stem Cell Therapy Association (ASCTA) at This group, whose founding members included Freeman, Centeno, and Centeno's partner John Schultz, espoused the same basic set of values that characterizes the ICMS, including an emphasis on the use of autologous stem cells as teh practice of medicine.

Whatever the case, the ICMS' general strategy seems to me to have consisted from Day One of: 1) the promotion of the use of stem cells as the practice of medicine.

In a remarkably short time, the ICMS became a credible organization, complete with various guidelines, an Offshore Clinics Report another patient portal (Stem Cell Watch), a newsletter, a Treatment Registry, which is at 750 registered patients and counting, and a Clinic Accreditation Program for clinics. The organization also recently announced a deal with an insurance company to provide malpractice insurance for their members. This, in my view, may prove to be one of the most valuable member service ICMS has introduced to date.

The accreditation program allows clinics to certify taht they are following guidelines. The first outfit accredited by the ICMS is the Regenerative Medicine Institute of Tijuana, Mexico. The ICMS process, took less than a year (the RMI application for accreditation was announced on March 15, 2011, and the ICMS approval announced on February 24, 2012). In the more recent release, ICMS executive director David Audley praised the clinic, saying, "The safety profile has been excellent. We have tracked patients over at least two follow ups and a minimum of six months and not seen a single cell-related adverse event." 

ICMS has also investigated clinics when adverse events were reported. This occurred when the organization announced investigation of the death of a patient treated at the same clinic, and then CNN later announced that the clinic's stem cell treatment didn't cause the death of the  two patients. The group's website issued a release noting:

The investigation of the deaths was led by ICMS Board President Dr. Michael Freeman, forensic epidemiologist and Affiliate Professor of Epidemiology at Oregon Health & Science University School of Medicine and Adjunct Associate Professor of Forensic Medicine at Aarhus University. The investigation involved extensive interviews and review of documents, as well as consultation with experts in clinical applications of stem cells, including Dr. Keith March, Professor of Medicine and Director of the Vascular and Cardiac Center for Adult Stem Cell Therapy at the Indiana University School of Medicine. As a result of findings uncovered during the investigation into the patients’ deaths, the ICMS initiated an on-site evaluation of ethical and clinical practices of RNL Bio, conducted by Dr. Glenn McGee, John B. Francis Endowed Chair of Bioethics at the Center for Practical Bioethics.
The ICMS has made the following findings:
  • The death of patient JJJ, which occurred nearly 2 months after his last stem cell infusion, was unlikely to have been caused by either the stem cells or the procedures used to administer the stem cells. The specific cause of Mr. Jun’s death is currently unknown as no documentation has been released with this information.
  • The death of patient LSK, which occurred on the same day as the stem cell procedure, was likely to have been caused or triggered by the stem cell procedure. The cause of death was due to a pre-existing blood clot that traveled to the lungs, and may have been precipitated by the procedure used to infuse the stem cells, or less probably, from a clot formed by the cells.
  • No evidence was found to suggest that inaccurate information caused either patient to give consent to medical procedures that they otherwise would not have given. A review of all relevant forms, chart notes, correspondence, and interviews suggests that both patients were provided sufficient information to give appropriate informed consent, and both did give consent.
The ICMS has accepted other applications as well. Take World Stem Cells, LLC, for instance. Located in Cancun, Mexico, this clinic flies the ICMS badge right on the top page of its website, and applied for accreditation last May

Chris Centeno has been keeping busy after being replaced by Freeman as head of the ICMS and is now locked in a legal fight over an injunction the FDA sought against his company Regenexx. He has licensed to partners in Argentina and China, and set up a stem cell treatment subsidiary in the Cayman Islands. He is also a planning committee member and speaker for this year's one-day ICMS-sponsored session in Hollywood, FL, held in conjunction with the annual meeting of the Age Management Medicine Group, alongside other such luminaries as Jeffry S. Life

It is too soon to say what will happen under new leadership, and best of luck to Dr. Rodriguez and the latest generation of ICMS leaders in setting the group on a course to science-based medicine.