Doug Sipp's Blog and Accuracy on "The CellTex Affair"-Part 1

My focus for the next several blogs will be to use what's publicly available on the Internet to check the accuracy of Doug Sipp's blog. My goal will be to pretend that I'm a reporter doing research. Basically, like a good reporter, I need to do my homework and confirm my sources. I won't make any judgements on the subject matter (like CellTex or RNL).

Doug and several other blokes have been agitating against CellTex Therapeutics, a company in the U.S./Texas whose claim to fame was treating Governor Rick Perry's low back with stem cells. While none of these bloggers knew much about what CellTex was doing, many focused on RNL Bio, a South Korean company that licensed it's stem cell technology to CellTex. Doug had previously made it his personal quixotic quest to take down RNL (see posts on 12/1/10, 11/16/10, 7/1/10, and 6/6/10) . So in this "affair" RNL became a proxy for attacks on CellTex.

So let's ask a question any good reporter should ask:

Was the RNL technology licensed to CellTex dangerous?
RNL Bio reported that it banked stem cells for about 8,000 patients who were later treated. The process was to take adipose stem cells from the patients, grow them in culture to greater numbers, and then to re-inject them locally at the site in need of tissue repair as well as intravenous. Of those patients, the families of two eventually testified against the company. Both believed that the injections were responsible for the death of their loved ones. So we have two suspected deaths in about 8,000 patients.

• Were the 2 deaths related to the treatment? There is only one group that commented on this issue in any detail, the ICMS. From this press release they state:

1. The two patients were not part of their registry, but they felt the need to investigate because they were patients treated with a common technique to patients in their registry.
2. The investigation of the deaths was led by 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 Centre for Adult Stem Cell Therapy at the Indiana University School of Medicine.
3. The death of patient 1, 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. 
4. The death of patient 2, 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 travelled 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.
5. So in conclusion, after an expert panel of university physicians investigated the deaths, one was related to the stem cell treatment.

What were Sipp's comments?  

"The ICMS promptly launched an "investigation" which unsurprisingly has found that the company was effectively blameless because they had patients sign informed consent forms prior to undergoing the procedures that appear to have killed at least two of them." 

What? Maybe this post was before the ICMS announced their findings? No, Sipp's post is dated 12/16/10 and the ICMS post discusses that they will discuss the findings at the Korean National Press Club (future tense) on 12/14/10. So Doug falsified the ICMS findings to suit his story line. If he had been a reporter for any news agency he would have been immediately sacked.

So just how dangerous is 1 death in 8,000 treated patients? Let's compare this to other drugs used by some of the same patients. RNL had treated patients with multiple sclerosis. One of increasingly popular FDA approved drugs that MS patients can use is called Tysabri (natalizumab). MS patients who use this drug have approximately a 1 in 800 chance of contracting a rare and serious brain infection called PML (progressive multifocal leukoencephalopathy), which is almost a certain death sentence. So there would have to be ten times the reported deaths for RNL's stem cell treatment just for it to match the leathality of a rising star MS drug! So why the Sipp alarm? 

To end this instalment on the accuracy of Doug Sipp (or lack thereof), Doug misrepresented the information coming out of ICMS on RNL so it would fit his story. Journalists are bound by an ethical code. The society of professionalism journalists has the following in their professional code:

"Journalists should:

— Test the accuracy of information from all sources and exercise care to avoid inadvertent error. Deliberate distortion is never permissible."

 As I will show over the next several posts, Sipp often distorts information or flat out misrepresents it altogether. He's on a bender of inaccuracy. So any journalist relying on Sipp's wonky information and taking it as gospel has a problem. 

Who is the real Doug Sipp?

Doug Sipp's blog has viciously attacked any physician using stem cells. While a few of his attacks have been against real bad actors, many have also been against physicians trying to do legitimate work. He's also attacked groups of sick patients who want access to this care. Why?

To understand Sipp and his blog, we need to digress back into his history. Doug is an American who has lived in Japan since the early 1990s. When Doug first arrived in Japan after college, he worked on "patient simulation software". He then worked as a freelance translator at the Nature Network. It's interesting that neither job was academic in any way, nor did either qualify him as being an expert bioethics or policy issues on stem cells.

He has commented on his tenure as a science translator. In one 2005 article, he boasts that translating science articles can be lucrative:

"Pay Translation can be a lucrative business or sideline in Japan, which offers some of the best per-word rates in the world. Fees for technical translations from Japanese into English range from ¥3000 to ¥6000 per page (US$23 to $46); English to Japanese translations pay a little less. An experienced translator working with familiar subject matter can earn in excess of ¥10,000 (US$77) per hour, but few people are able to maintain that pace for a full 8-hour workday."

That's more than 140K USD a year! (or 88,500 pounds)! So we know Doug had a smattering of first jobs after a four year college degree and was making some serious cash translating science articles.

He states in his profile on the Nature Network that he now manages communications for a research institution in Kobe Japan. What is that research institution? The Riken Centre is a large and often entrepreneurial group of different labs scattered across Japan. 

While Riken seems like a credible place that does legitimate science, it has also done some nutso things in recent years. They have recently been in the news for trying to clone woolly mammoths. This is despite Japan's neighbour south Korea being infamous for serious ethical issues cloning dogs and cats. In fact, a science daily news site reported that Riken had taken "one giant leap for mankind" by reviving...wait for it...a dead rat!

The Riken Zombie Rat...

So is Riken merely a government research institution with no financial incentives? Not really. This on-line page explains how centers like Riken can cash in on bio-tech. Nature has described how Riken works with pharma companies to license their valuable patents. This page at the Riken Centre web-site explains more about how Doug's bosses in the life sciences area monetise their science. While their work is supposedly funded by the government, as one example, if you use Riken's cell clones to find something that leads to a patent, like the Yakuza, the center wants it's cut! In fact RIKEN filed a total of 998 patents in fiscal year 2008-2009. RIKEN has even set up a program it calls a "Baton Zone" that it explains as:


"Integrated Collaborative Research Program with Industry
Projects on topics proposed by private industry are undertaken at RIKEN to integrate the two parties’ expertise. An ad hoc collaborative research team, headed by an expert sent from the company, is formed to construct a technology platform and to realize prompt commercialization of research outcomes."

Riken-We want our "Vig"...

What's interesting is that Sipp's bosses at Riken have created an entire centre to commercialise patients (read turn them into cold hard cash). The tag line says it all, "Managing technology to create value". 

The web-site claims that "The RIKEN Venture system enables researchers to put their own world-class scientific achievements to commercial use". Read, "big pay day for scientists"... Heck, RIKEN will even give you office space in their buildings! How many companies have taken advantage of this program? 24 and counting... 

That company list is interesting in that the most prolific area of university-private payola is...you guessed it-Biology! 

Now is this characterisation of the Riken center and Doug's bosses fair and balanced? Maybe not, yet Doug has never been fair and balanced. What is fascinating, is that despite friendly news organisations noting that Doug's work is nasty...

CE: Well, now that you mention “rhetorical license,” let me ask you something else.  You don’t exactly mince words on the blog.  

...Doug's employers seem to turn a blind eye. In fact, there's every indication that his employers love his hate speech. While he started out as a communications director, after he began viciously and often unfairly attacking stem cell clinics and sick patients that were competitive to the interests of the his bosses patents on iPS cells, he got a promotion to the director of bioethics and policy for that unit. Funny thing, he knows nothing about bioethics! He has a four year degree and did not major in bioethics. He holds no masters degree nor doctorate in the field. Frankly, it's unlikely that he would qualify as a graduate student in bioethics, let alone a director of bioethics!

More on Doug's Bosses and why they would support his hate speech...

[I want to thank an anonymous reader of the blog for some of this information]. As discussed, Sipp works at a research center that uses competitive technologies to the adult stem cell clinics he bashes. In fact, the Riken Center is involved in the MEXT iPS cell research network which focuses on the distribution of iPS cells as well as patenting and licensing of intellectual property (iPS cells). 

iPS cells are a very popular topic in Wall Street biotech plays as unlike adult stem cells; they can be patented like a drug chemical (as they don’t exist in nature) and mass produced in bioreactors for mass distribution like a drug. If iPS cells become a clinical reality, these Riken patents would be worth a fortune to the bio-pharma industry and this centre. So what could possibly threaten the commercialisation of the science breakthrough known as iPS cells? Safer adult autologous stem cells being used by physicians as transplant surgeries instead of drugs. After all, why would a doctor use very expensive iPS cells provided by a pharma company through a Riken license if cheaper stem cells from the patient's own body would work as well?

While Sip has done a great job concealing his true intentions from the press, this talk that he gave in London in 2010 really says it all:

"Appearing: Congress Day 3 Thursday 13 May 2010 - AFTERNOON PLENARY SESSION 4:20 PM

Overcoming the threat to legitimate business: medical tourism and the stem cell industry"

Who are the “legitimate” business interests? Doug's bosses of course! If the Riken centre has no financial skin in that game, why is it filing for about 1,000 patents a year and licensing them to private industry? (see US 2010/0167398 A1 and US 2011/0091869 A1). If its interests are the pure pursuit of knowledge, why file for a patent at all? 

We can even drill the cells for profit scam right down to the scientists in Doug's unit. For example, why is the director of the group where Mr. Sipp works on the scientific advisory board for iPS Academia Japan, Inc?

What is iPS Academia Japan? It’s a for profit business entity devoted to cashing in on the discovery of iPS cells. This is from their web-site:

"Our main task is to manage the patents and other intellectual property relating to iPS cell technology, and grant the license to entities under such patents and intellectual property to use the technology in healthcare and pharmaceutical research as well as in drug discovery and to commercialize the iPS cell-related business."

In summary, who is Doug Sipp? I live in the UK and in this part of the world we have an ancient custom of "sin eaters". The general idea is that some poor bloke is hired at a funeral to "eat" (read internalise) the sins of the dead so that the deceased can more easily make it to heaven. This concept has now also been generalised to mean someone who does the nastiness to keep others pure.

I view Doug as a "sin eater"The recent movie, "The Borne Legacy" explains it well. After just being given and carrying out an order to do something heinous and horrible against civilians, the main character, a military operative/assassin, gets a pep talk from his boss:

“We are the sin eaters. It means that we take the moral excrement that we find in this equation and we bury it down deep inside of us so that the rest of our cause can stay pure. That is the job. We are morally indefensible and absolutely necessary. You understand?”

Doug and his bosses consider Doug to be morally indefensible and absolutely necessary and he is assigned the dirty work so that their cause can appear to be scientifically pure, even if what they are actually doing is harming patients by limiting choices and access. 

Celltex

Celltex

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."

By David Plotz|Posted Wednesday, Feb. 29, 2012, at 9:43 PM ET

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 company, the 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

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

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 http://www.box.com/s/vzlh0sqt3v987m33vnfj).

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 Disorders, for which he and Freeman, served as co-editors-in-chief.

http://web.archive.org/web/20050210122622/http://whiplash101.com/

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 www.stemcelldocs.org. 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. 

http://worldstemcells.com/stem-cell-therapy-conditions.html

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. 

Yes, that 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.