Chinese cemetery operator invests in stem cell anti-aging

Late last year, a Hong Kong-based Caymans-incorporated company, Zmay Holdings, caught the stem cell fever, plunking down around $40 million (a total of 330 mil HKD) in bonds and equity in a deal for a technology that apparently involves growing various types of human stem cells from ordinary somatic cells by treating them with Chinese herbs like ginseng, angelica and bitter melon, or a dash of deer antler and leech extract if you have them handy. The specifications are strangely quiet on the feng shui conditions under which these processes should be conducted - I'm guessing trade secret. Jokes aside, this looks like another step in the inexorable march of so-called "stem cells" into penumbral territory usually occupied by homeopathy, energy healing and Baron Samedi.  


Zmay, whose English website reveals one of its primary business to be funeral services and cemetery management, bought the tech from inventor Xiongbin Lin, through a contorted (to me, anyway) deal involving multiple foreign-registered holding companies and fronts. No mention is made of whether anti-aging customers who die as a result of "stem cell" treatment will get a deal on a headstone and plot of turf.

Death - the ultimate anti-aging solution

Forty mil is big money by any measure, especially for a technology that has not been described, or even mentioned, in a peer-reviewed journal - at least not that I could find in English. And the new licensees have lost no time in seeking to capitalize on their investment. The Institute of Anti-Aging Medical Research on Stem Cells (Hong Kong) Limited, which was acquired from Lin as part of the deal, has recently changed its name to 159 Anti-Aging Center (H.K.) Ltd., registered a web domain, and is on a hiring spree. A bolus of stem cell cash can't come to soon for Zmay, which has suffered recent financial losses and suspension of trading of its shares on the HK Gem boards last month. 

It's always hard to tell who the final sucker will be in deals of this ilk, the licensees, or the prospective patients they try to foist their schemes onto - whoever it is, my friends, don't let it be you. 

How many FDA auditors can you fit in a PO Box?

Ask the ICMS.

The International Cell Marketing Service Medicine Society reports that the FDA has audited its institutional review board (IRB), which the ICMS claims has been asked to review "nearly two dozen study applications over the last 3 years from nearly a half dozen countries."

The FDA has looked into a number of other IRBs in the past, including the unfortunately named Coast IRB, and a perhaps somewhat less than conscientious operator in my native NJ, Essex, which was recently busted, yet again, by Dateline NBC. Those are just the tip of the iceberg - the folks at CIRCARE have a whole catalog of IRB warning letters from the FDA chroncling oversight lapses on the part of supposed watchodgs. U Minn ethics professor Carl Elliott has been calling attention to the problems raised by fig-leaf IRBs and their porous reviews of clinical research for years now. It will be interesting to learn whether the FDA puts ICMS's review process in the same category.

Meanwhile, over at the iPS cell blog, Paul Knoepfler is reporting that the FDA has been busy down Texas way as well....

Stemedica thrives on neglect

Stemedica is a San Diego-based stem cell company founded in the mid noughties to harness and commercialize "adult stem cell technology and therapies for the treatment of neurodegenerative diseases." The principal movers and shakers behind the launch of this private venture were two American brothers - Roger and Maynard Howe - and their longtime Russian business partner, Nikolai Tankovich. The Brothers Howe have said they were driven to this area of medicine after a sister-in-law was severely injured in a car accident in 2004 that left her paraplegic, and after hearing of miraculous advances in cell medicine in the former Soviet Union. A compelling story, but one that neglects a few salient details...

The Stemedica Three

After taking their sister-in-law to Moscow for stem cell injections in 2006, the company claimed that, "Within four months, many basic life-functioning abilities began to return and [she] was able regain her independence". By the next year the Stemedica team had announced a network of international treatment centers in places like Mexico, Italy, Switzerland and France, with others to follow in Bermuda and Korea. The plan was to use various types of "adult stem cells" (apparently including fetal-derived neural cells), in combination with lasers and other devices, to treat diseases such as "stroke, Alzheimer's, Parkinson's, ischemic head trauma, spinal cord injury, diseases of the eye such as age-related macular degeneration and diabetic retinopathy as well as skin, scar and bone regeneraton [sic]". 


A visitor to the Stemedica website circa 2007 was also greeted with an impressive list of institutional "strategic relationships" sporting the logos of Stanford, UC Irvine, and the Burnham Institute, among others.

By 2009, the company website had removed all mention of treatment centers and Stemedica was well on its way to amassing a collection of biotech merit badges, including state certification of a cGMP cell bank, FDA authorization for a Phase I/II clinical trial, and more recently, a patent on a cellular scaffold invented by Stemedica CTO, Alex Kharazi.


But when you're talking about overseas treatment/profit centers, gone does not necssearily mean forgotten, and Stemedica continues to have unusually cozy relationships with a number of clinics outside the US that openly advertise stem cell injections for a thick catalog of afflictions. 


The Regenerative Medicine Institute in Tijuana, Mexico (which I have blogged a bit about before) is just 30 miles south of the Stemedica office. The first clinic to be accredited by the ICMS, the RMI (which is set up within the Hospital Angeles Tijuana medical tourism operation in Mexico) offers stem cells for dozens of conditions, from cerebral palsy to frailty syndrome, under a novel business scheme in which patients are told that, for $10,000-$35,000 they can buy their way into a "clinical trial" absent many of the features like controls, randomization, or blinding that would actually make it possible to generate any scientific insights into the efficacy of the investigational product. 


The institute's StemCellMX website encourages users "To find out if our trials are right for you please contact us using the form on the right". Essentially, they ask their customers to be subjects in medical experiments, but to pay as if they are receiving therapy. Some have begun to complain. 

Stemedica's ostensible connection is as a provider of allogeneic stem cell technology for use in one such trial for stroke. A page deeper in the StemCellMX website, however, explains how a different Howe brother, David (who has an M.D. from Ross University in the Dominican Republic), accompanied 19 patients with serious, unrelated medical conditions like autism, muscular dystrophy, spinal cord injury and hearing loss to Moscow for similar experitherapies (theraperiments?), claiming 89% improvement. The doctor in charge of these procedures was Nikolay Mironov, a member of the Stemedica Scientific Advisory Board, and the treating physician at Global Stem Cell Health (treating stroke, spinal cord injury, traumatic brain injury, Parkinson’s, Alzheimer’s, cerebral palsy, multiple sclerosis, muscular dystrophy, etc.), a company co-founded by former Stemedica director of medical services, Michael Bayer. (Bayer had previously run Bayer Stem Cells, a now-inactive site with a very similar M.O.)


The link between Hospital Angeles and Stemedica goes back at least to the 2007 list of Licensed Treatment Centers on the Stemedica website (and even today, Cesar Amescua of Grupo Angeles is Stemedica's medical and regulatory affairs director for Latin America). Also on the 2007 list is the Brown-Darrell Clinic in Bermuda, which was slated to be launched in 2008 in collaboration with Ewart Brown, then-Premier of the island nation, and his wife Wanda. The opening had to be postposed after a local media firestorm ignited over the propriety of opening a stem cell hospital in a country in which medical regulations for cell therapy were not in place, and the Brown-Darrell clinic vanished from Stemedica's site. Five years later, no such guidelines have materialized and the controversy simmers on.


During the 2007 hubbub, the Bermuda Sun earned itself a heartfelt hat-tip for doing  background and fact checks on key players at Stemedica. They revealed that CEO Maynard Howe, Ph.D. was a "marketing expert with a Midas touch" who had made tens of millions from the sale of an anti-wrinkle laser, at a company in which Roger and David Howe and Nikolai Tankovich were also all partners (as was Roger's son Derek, the VP of operations at Stemedica at that time). The Sun reported that Maynard was also chairman of a nutraceutical company selling something called Nanogreens (the healthy fast food!).


The Sun also cast light on CMO Nikolai Tankovich, a physicist who first struck it rich with a hair-removal laser, before setting up the company Aquaphotonics and developing a cellular hydration bottled water product that was marketed as Penta Water; the company claimed that its structural differences from ordinary water made it better at hydration. Penta earned the rare distinction of being called out on its spurious claims on separate occasions by skeptic icons James Randi and Ben Goldacre, among others (Goldacre later wrote that he received anonymous threats after voicing his doubts about Penta.) In 2005, the UK Advertising Standards Authority upheld a number of complaints against Penta for misleading claims.

Alkhass (Amni), Schuller (Stemedica Intl., Amni)

Meanwhile, in the Rest of the World, Stemedica has continued its empire-building and regulatory arbitrage overseas. In recent years, they have inked a deal with Jordanian Stem Cell Company, chaired by Prince Asem Bin Nayef of Jordan, and partnered with Amni BioScience, a Middle East regional biz headed by fellow San Diego citizen Sam Alkhass (who also brokered the Jordan alliance), and counting Tankovich and David Howe, as well as Stemedica International chief Frank Schuller, and Mark Tager, Stemedica executive for dermatological operations, and another 'nother Howe brother, Bruce, on its team.


Stemedica is popping up all over Asia, entering a joint venture with AnC Bio in Korea, and launching Stemedica Asia in Singapore. In China, Maynard and David held an Educational Forum with W.A. Stem Cell Technologies, a company recently exposed in a Nature article that detailed how its medical tourism arm offers a double dose of stem cells (adipose, cord blood) for autism for 250,000 RMB (around $40,000), in apparent violation of the Chinese Ministry of Health's efforts to rein in over-the-top claims of stem cell efficacy. W.A. is headed by Shu Li, a former engineer who also goes by the name of Taichi Tzu, holds a patent on negative gravity therapeutic methods, and has "been practicing Taoist alchemy for over 15 years."

Maynard and David go to Shanghai

Stemedica also shows up in the logo roll on the website for Beijing's IPM Group (also known as Beijing Damcell Bio-Medical Technology), alongside the heraldry for Harvard, Oxford, and Cambridge and STEM-CELL.KZ (website archived here), a seemingly now-defunct company in Kazakhstan, the country where Daniyar Jumaniyazov has been injecting heart patients with Stemedica cells as part of a trial at the National Medical Research Center in Astana, in collaboration with Nikolai Tankovich. (Jumaniyazov is also a member of the Amni team). 

Some people might see Kazakhstan as a less than obvious choice for a Phase II clinical trial, but at least two U.S. cardiologists, Nabil Dib and Jackie See, called the announced results "promising" and "impressive" in a recent press release. What the Stemedica release fails to mention is the direct ties between the company and these commentators; Jackie See is on the Stemedica scientific advisory board, and that Nabil Dib is a special advisor to the board.


The release also fails to mention that Jackie See, himself a member of the physician team at California Stem Cell Treatment Center (which offers stem cells for (among others) asthma, hair loss, incontinence, MS, kidney failure and Peyronie's disease), has been in trouble in the past for scientific fraud. In 1999, the LA Times reported how Harvard Scientific, a company at which he was director for research, got into trouble with the FDA for submitting "misleading and erroneous information about a clinical study" for an agent being tested for treatment of sexual impotence. Predictably, this hurt Harvard Scientific's share price, triggering an investor suit against See (RK Company v See). According to the circuit court ruling, the court "repeatedly described Dr. See's testimony as not credible," and the plaintiff (who was himself in prison at the time on bribery and racketeering charges) won.


The press release also neglects to disclose that Nabil Dib is the director of cardiovascular research at Mercy Gilbert Medical Center in Arizona, one of the sites where Stemedica is conducting its stroke clinical trial. It further omits Dib's former role as chief of staff in the stem cell transplant clinic at Stowe Biotherapy. The proprietor of that business, Larry Stowe, surrendered to authorities this January after 60 Minutes caught him and his then-partner Frank Morales offering stem cells and tall tales to an ALS patient, on camera. 

Neglecting the inconvenient seems to be the norm at Stemedica. When the Brothers Three and Tankovich co-authored a book (The Miracle of Stem Cells), the company neglected to mention that the president of their publisher (ChangeWell Publishing) is Stemedica's dermatology exec, Mark Tager. When the radio show In Our Life Time interviewed Maynard Howe about his life, his company, and "the miracle of stem cells" the show's host, Dave McGuigan, neglected to mention that he also serves as Stemedica's VP for Marketing and Business Development, despite having an hour to do so. And when Stemedica announced that company president Nikolai Tankovich had been named legate at the obscure Centre for Science and Society in Oxford, they neglected to mention that the director of that centre, Frank C. Schuller, is also head of Switzerland-based Stemedica International. 

We're in the business of miracles  

Stemedica even almost entirely neglects to mention that some of its "adult, allogeneic stem cells" are actually fetal in origin (the mincing code for this apparently being "taken from donated brain tissue"). Fetal cell injections have a history of being ethically problematic and potentially dangerous, when used outside the a well-regulated, scientifically controlled context. (Readers interested in a disturbing, long-form exposition of a fetal cell treatment gone haywire should check out this chapter from the book, When Science Goes Wrong.)   


Riccardo Nisato, Director of Manufacturing and Clinical Business Development at Stemedica International, did in fact drop the F (for "fetal") bomb in a single comment announcing his appointment back in 2009, which Stemedica's neglecters seem to have neglected to neglect but, to be fair, he was still new back then and may have missed the memo.


The sister-in-law whose accidental paralysis kicked off this latest family venture died back in 2009. But while she was still living, a local magazine reported that, despite the hype, "an MRI performed in June revealed that the stem cells had not repaired her spinal cord." In the end, she attributed her perceived progress "to God." 

Q&A with Carl Elliott

Carl Elliott, a bioethicist at the University of Minnesota and author of such works as White Coat, Black Hat and a recent article on Slate that, shall we say, burned bright, hot and fast, interviewed me and posted our conversation on the Brainstorm blog at The Chronicle of Higher Education. Carl is known for his courageous and influential work on serious issues in medical ethics, so it was a great honor for me to have this opportunity to talk about about the history of this blog and issues in the predatory marketing of stem cells. 

More than minimally manipulative

While the Celltex travesty was unfolding down in Texas, the International Cellular Medicine Society (ICMS), a marketing-savvy group of proponents of the deregulation of stem cell injections, announced the appointment of plastic surgeon Ricardo Rodriguez as its new president. Dr. Rodriguez, whose advertised procedures include BOTOX, breast augmentation (warning: link may be NSFW), and the B'more butt-lift, will be the third leader of this organization, which has shown a frankly astonishing ability to project its simplistic, stem cell business-building 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 to promote expensive, wild-eyed stem cell schemes without independent oversight or evidence of safety and efficacy? The tale is long and very, very twisted, so I'm afraid I'm going to need to ask a bit more of your time than usual to explain why I think the ICMS is not all that, and much more than, it seems.

Let's go back to the roots. If you ever find yourself in Salem, Oregon, try heading south of city center to a downscale neighborhood near the municipal airport and Stone Quarry Lake. Drive a few hundred meters down 22^nd St, to where the sidewalk ends just east of McGrath’s Fish House and Prestige Auto Repair, and you will find the global headquarters of the ICMS: a post office box at 2667 22nd St SE, Salem, OR 97302. If you need directions, the ICMS graciously provides them on its Facebook page, although I generally prefer Google Maps to Bing, if only for the pictures...

The bleeding edge of stem cell therapy...

... on the banks of Stone Quarry Lake.

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, is himself no stranger to Salem - the ICMS mailbox is less than 10 miles from the clinic where, in 1991, he and four other chiropractors (including Freeman's father) were accused by the state of fraud and racketeering for using a doohickey known as a Toftness Device (but as the court documents note, also referred to as a "radionics detector" or "Freeman device"). The online Museum of Quackery points out that these *ahem* diagnostic tools were rigged together from PVC tubes and couplings. The defendants asserted that the device they used in their practices was, however, substantially different from the TFD, as it included "rubbing plates" and anyway, had been approved by the Oregon Board of Chiropractic Examiners - so there! In any case, the case was dropped even though the chiropractors did not deny using these devices, giving Freeman a defendant's-seat view of the amazing healing power of wriggly legal maneuvers. 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 a non-self-reflective lecture on "Exposing, defusing and debunking junk science" in Los Angeles this January.

Hat tip, Eugene Register-Guard.

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 (sorry, paywall) and their next six papers have nothing to do with stem cells, but rather various forms of spinal injury, with a focus on whiplash. 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 orthopedic surgeon George Muschler, in the FDA vs Regenerative Sciences case (via a link in this story on HuffPo). At 107 pages (48 pf which are Muschler's CV, and several of which have been redacted), this is not for the short of time. But for anyone interested in seeing what an actual scientifically-minded M.D. makes of the published claims in support of Centeno's Regenexx™ stem cell product, it is definitely worth a read. My one-word summary would be: scathing. For the curious, I have excerpted a few choice passages below:

Based on these observations, while I have no reason to question the motive of Dr. Centeno et al. to provide service to patients, I am concerned at this point that continued progress along the direction that has currently been established may be degenerating into an undisciplined and unfocused and even groping and wishful fishing expedition. The process that has been established does not appear to be subject to adequate oversight at the level of the IRB. From the personal level, this has the risk of exposing hopeful patients to a broad range of unnecessary and unproductive clinical therapy attempts under the banner of a “research investigation” that is, in fact, incapable, by design, of detecting the very treatment effect that RS purportedly hopes to demonstrate. On the medical level, I am concerned that the studies, as proposed, are being conducted using a culture expanded cell product that has not yet been adequately characterized. Furthermore, product specifications for quality assessment have not been defined, specific release criteria are not articulated, and the product has not been subjected to a rigorous assessment of safety that satisfies contemporary practice standards. [Muschler declaration, p. 31]

 and..

According to the paper [referring to (Centeno CJ et al., Safety and ComplicationsReporting on the Re-implantation of Culture-Expanded Mesenchymal Stem Cells usingAutologous Platelet Lysate Technique, Current Stem Cell Research & Therapy, 2010;5:81-93)], four of the six authors (Centeno, Schultz, Cheever, and Robinson) have equity ownership in RS. Centeno 2010 article at 81. Another author (Marasco) has equity ownership in NeoStem, a company to which RS has reportedly licensed the Regenexx procedure in Asia. http://www.regenexx.com/2009/05/regenexx-in-china/ (November 22, 2010). Thus, all but one of the authors in this report have direct financial conflicts. Of particular note, Dr. Centeno and Dr. Schultz served as the only two reviewers charged with screening follow- up MRI scans for evidence of abnormal growth or tumor formation. Centeno 2010 article at 82. They also served as the only two adjudicators of patient complaints. Id. at 83. [Muschler declaration, p. 38]   

and furthermore...

Although bearing more on the ethical context of these studies than their scientific context, the IRB overview of these studies warrants brief discussion. The IRB that took responsibility for review, approval, and oversight of the studies authored by Dr. Centeno is identified as the Spinal Injury Foundation IRB. In the case of the Centeno 2010 article, the paper states that treatment of the “Group 1” patients was approved by the Spinal Injury Foundation IRB. Centeno 2010 article at 81. No mention is made of any IRB approval of treatment of the Group 2 patients discussed in that study. 

From records provided to me, it appears that Dr. Centeno has an unusually close relationship to the Spinal Injury Foundation IRB: Dr. Centeno was the registered agent and Medical Director of the Spinal Injury Foundation. See 2009 EIR Attachments 6-7 (Kreuzer Dec. Exhibits 19-20). It should be noted that Dr. Centeno apparently recused himself from voting on the IRB’s approval of the studies. It is not clear if he was also excluded from the review and discussion of these protocols and/or if the voting records of IRB members were secret, so as to minimize potentially biased influence of a professionally and financially conflicted member. It should also be noted that John Schultz, M.D., and Michael Freeman, Ph.D., who are listed as co- authors on some of Dr. Centeno’s publications regarding the RS cultured cell product, were also members of the SIF Board of Directors.

It is of potential significance that, according to the current (November 22, 2010) Spinal Injury Foundation website (http://www.spinalinjuryfoundation.org/), the Spinal Injury Foundation is now operating under a different name, International Cellular Medicine Society, which is located in Oregon. Among the nine points in the ICMS mission statement is the goal: “To establish that when A-ASCs are minimally culture expanded, are not biologic drugs but rather human tissue.” http://www.cellmedicinesociety.org/physicians/join (accessed November 22, 2010). Dr. Centeno also serves in a leadership role in ICMS, specifically as the Medical Director. http://www.cellmedicinesociety.org/home/boards-and-councils/board-of-directors (accessed November 22, 2010). [Muschler declaration, p. 40]

The TL;DR summary: Centeno and Freeman were 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™ product line that one expert noted as being at risk of "degenerating into an undisciplined and unfocused and even groping and wishful fishing expedition." 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, a resource used to, among other things, direct patients to apply for a one-hour consultation with Centeno for $350. Centeno also founded an (also now-defunct) online Journal of Whiplash and Related Disorders, for which he and Freeman, unsurprisingly, served as co-editors-in-chief. 

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

Centeno and Freeman's Spinal Injury Foundation ramped up its marketing game even as they were careening off toward the stem cell fringe, running awareness days and other fundraisers including, in 2007, the novel concept of rewarding anyone who donated $1495 to this whiplash organization with 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 n=1 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. What Centeno (the person) specifically did not sell, however, was intellectual property surrounding a certain stem cell process he had cooked up while running the Spinal Injury Foundation, and Whiplash 101, and his busy clinic, and the whiplash journal, without (as far as the literature reveals) any previous published indication of interest, ability, or experience in stem cell research and development. Another stem cell miracle!

Stem Cell Intellectual Property .  (i) Any and all activities and work product of Sellers regarding regenerating damaged or degenerated tissue, including, but not limited to, the development and sale of a turnkey solution for the isolation, processing and expansion of autologous stem cells for such regenerating damaged or degenerated tissue and the pursuit of any and all business opportunities available as a result of such activities; (ii) any and all work and work product of Sellers related to the isolation, processing and expansion of autologous stem cells; and (iii) any and all work and work product of Sellers related to the isolation, “processing” (as hereinafter defined), expansion and “storage” (as hereinafter defined) of autologous stem cells and/or storage of stem cells, Mensenchymal stem cells, chrondrocytes, or other unnamed progenitor cells, including but not limited to the development of short and long term stem cell storage plans.  “Storage” means the freezing or otherwise storing stem cells in a suspended activity state for later use.  “Processing” means includes but not limited to manipulation, expansion, isolation, purification, and/or differentiation of autologous stem cells or any stem cell line. [from PainCare - CJC Asset Purchase Agreement]

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 eponymous assets for a small fraction of the original selling price.

Not long after this settlement, Centeno and Freeman were cobbling together 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, as well as, o-ho!, Centeno's fellow University of South Florida alum Zannos G. Grekos (someone readers of this blog should certainly recognize), espoused the same basic set of values that characterizes the ICMS, including an emphasis on the de-regulation of autologous stem cell products, and a strange insistence that dark forces stand in the way of stem cell progress (with enthusiastic support from the bleachers at Stem Cell Pioneers, and its own, now apparently static, patient info portal, safestemcells.org). 

Over the years, the ICMS has embraced a galaxy of stem cell proprietors, the likes of Korea's own Booger-cloning Ra Jeong Chan [wayback], and Jorge Tuma [wayback] and Augusto Brazzini [wayback] of Peru on various councils, although you won't find much trace of them on the current version of the site. But even after making the transition to an "international" society, the group has maintained some oddly America-centric positions, including the oath it requires prospective board and council members to take prior to entering service (secret decoder ring not included):

Advisory Board and Council Members must affirm that minimally culture expanded stem cells are 1). Part of the practice of medicine and used as part of a physician practice in one state and through the state practice of medicine, 2). Do not constitute the creation of a new biologic drug or product that would fall under any part of FDA regulation on new drugs or biologics and 3). Exempt from any US Food and Drug Administration regulations.

Note that this vow makes no mention of the substantively similar provisions for the regulation of human cell and tissue products in the EU, UK, Canada, and other countries, which seems strange for a group that labels itself "international." 


Whatever the case, the ICMS' general strategy seems to me to have consisted from Day One of: 1) the promotion of treatments based on human cells that have not been subjected to rigorous scientific study or independent oversight; 2) the encouragement of healthcare providers to challenge and indeed violate existing laws established for the protection of patients; and 3) the invocation of baseless conspiracy theories and legal attacks when such practices are criticized and prosecuted (which I call the "tout, flout, and pout" model). 

In a remarkably short time, the ICMS whipped itself into the semblance of a credible organization, complete with various guidelines for budding stem cell entrepreneurs, an Offshore Clinics Report (which if nothing else serves as an excellent scorecard for what clinics have signed up with ICMS), another patient portal (Stem Cell Watch), a newsletter, a Treatment Registry for which patients were charged $350 to store their own treatment information, which at 750 registered patients and counting means at least another $262,500 for this NPO (and as I noted in an earlier post, the inclusion of RNL Bio in the ICMS Treatment Registry at $50 per patient on the provider side would potentially have cost that company $400,000+), and a Clinic Accreditation Program for clinics willing to pay the society for a fig leaf to plaster on their website (more on this below). Without apparent irony, the organization also recently announced a deal with an insurance company to provide malpractice insurance for their members (many of whom have built businesses around putative stem cell injections supported by guesswork, anecdote, slapdash research, and "expert" hand waving). This, in my view, may prove to be one of the most valuable member service ICMS has introduced to date, and I'm sure it will see plenty of use....

Short of "stem cell" cred? We've got you covered.

The accreditation program, however, is their marketing master stroke, as it lends a veneer of authenticity and a web-friendly banner to otherwise incredible stem cell-flavored medical claims made by enrollees. The first outfit accredited by the ICMS is the Regenerative Medicine Institute of Tijuana, Mexico. The ICMS process, which was originally announced as taking a rigorous 18 months, 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 and marketing whiz 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." 

This is remarkable, as only four months earlier the ICMS announced an investigation of the death of a patient treated at the same clinic, and then just two weeks later announced the expected finding that its paying customer was not to blame, based on what appears to be only partial evidence (e.g., no autopsy), interviews, and testimony. No mention is made of the identities of the three physicians who conducted the investigation on the ICMS' behalf, or of the ethicality of subjecting a a frail ('"the patient was told by his family physician that he was very weak and that another infection would most likely be fatal") 74-year-old man with lung disease to an uncontrolled, for-profit medical experiment in Mexico.

The RMI, which is operated by the Angeles Health International medical tourism network and connected to the website www.stemcellmx.com, is itself worthy of another long and detailed post, particularly given its close relationships with Bioheart and Stemedica, two US-based companies with registered clinical trials (here, here), and its extraordinarily long and diverse list of ungrounded treatment claims. By this, I mean Parkinson's disease, and Alzheimer's disease, and traumatic brain injury. And stroke and cerebral palsy and multiple sclerosis. And heart failure! And don't forget macular degeneration and glaucoma and diabetic retinopathy. And diabetes and kidney failure to boot! 


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 of shame right on the top page of its website, and applied for accreditation last May, which if the RMI experience is any indicator, means the results of the "18-month" review are already overdue. I don't feel like typing the long list of World Stem Cells' treatment claims in its entirety, so please feel free to click away below. 

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

Ever the businessman, Chris Centeno has been keeping busy after being replaced by Freeman as head of the ICMS, and unceremoniously dumping his previous NPOs and the whiplash journal he launched. In 2010, he tried unsuccessfully to sue the FDA (revealing in the process that by June of that year his company, Regenerative Sciences, had already performed 43 unapproved treatments earning $236,500 and banked 242 patients' cells at $5,000 - $8,000 a pop; i.e., $1.2 to 1.9 million in revenue), and is now locked in a legal fight over an injunction the FDA sought against his company Regenexx. He has licensed his cultured cell product (Regenexx-C) 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 alt-med luminaries as Jeffry S. Life (alternative medicine is, anyway, familiar turf for Centeno). 

Yes, that Jeffry S. Life.

So forgive me for my skepticism. Having watched the crass casuistry, hucksterism and vampire squid ethology that have characterized the organization so far, I can't help but think the real meaning of "ICMS" is International Cellular Marketing Service. It is too soon to say whether things will change under their 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. But given the proven profit potential of many other companies selling variations on the stem cell miracle cure, and the growing demand for weaselly workarounds to independent pre-marketing safety and efficacy requirements of the sort the ICMS has specialized in to date, I wouldn't bet my life on it. 


And neither, my valued reader, should you.