Friday, January 23, 2015

A Stem Cell Scam Unravels…

As many MS patients are aware, stem cells represent one of the great hopes for vanquishing multiple sclerosis by way of their tantalizing potential for repairing damaged brain and spinal cord tissues, regulating aberrant immune responses, and ultimately restoring patients to good health. Research into the use of stem cells to treat a wide variety of diseases is increasing seemingly by the day, and scientists are beginning to unlock the tremendous promise of these emerging therapies. The therapeutic use of stem cells may dramatically transform the medical landscape in the coming years, and this prospect provides much-needed hope to patients desperately searching for answers.

Sadly, where there are significant populations of desperate people, there are almost always human sharks ready, willing, and able to take advantage of them. Thus, it seems, we have the story of Regenetek, a Canadian company that arranged for patients to travel to India for an experimental stem cell treatment under the guise of a certified medical clinical trial. Over the last several weeks, the Canadian press has revealed that the man behind Regenetek, Mr. Doug Broeska, allegedly misrepresented his credentials, the qualifications and abilities of his company to conduct a valid medical clinical study, and cajoled, bullied, and berated patients who dared question his authority or the veracity of his claims (click here). It must be said that while some of the patients who underwent the Regenetek’s stem cell therapy in India received no benefit, others have reported good results, and that’s where this story gets tricky. Though Regenetek and Doug Broeska may turn out to be complete shams, the stem cell therapy the company was hawking may have value, at least according to patients who claim to have seen benefit from it (click here).

I first became aware of Regenetek when Mr. Broeska invited me via email to join Regenetek’s private Facebook group, where patients discussed various aspects of the company’s stem cell treatment and their experiences with it. At that time, Broeska was known as Dr. Doug Broeska, or “Dr. Doug”, claiming that he was a “PhD medical researcher”. That rather generic designation set off a few red flags in my mind, especially after a quick Google search revealed little other than the fact that Mr. Broeska had been involved in some sort of electronic medical records company before taking an apparently rather sudden interest in stem cells.

Further red flags sprung up when, after spending a little time on his Facebook page, I saw that Broeska was posting articles he had written on various stem cell related subjects that contained errors and misinformation. These articles were also posted on Regenetek’s website and blog. One article in particular raised my cackles, a piece about HSCT – a type of stem cell therapy in which a patient’s immune system is ablated using chemotherapy drugs and then rebooted through the use of bone marrow derived stem cells, which clinical trials are proving to be quite effective in properly selected patients – that was so ill-conceived that I felt compelled to call out the myriad inaccuracies in the piece. After a bit of back-and-forth, Broeska removed the article, but his seeming intentional misrepresentations of fact set off alarm bells of doubt in me about his credibility.

As I’ve mentioned in the past, I’m not a huge fan of Facebook, and after the above incident I didn’t spend much time visiting the Regenetek page. I was left with questions about the clinical trial the company was supposedly conducting, since it seemed that the only follow-up being done after patients returned from India were e-mailed anecdotal patient self-reports of how they were doing post treatment (no MRIs, neurologic testing, or other objective measures required), as well as doubts about many of the statements and claims made by “Dr. Doug”, but I’d seen how anybody raising such concerns on the site were met with hostility and frankly wanted no part of it. I remained in email contact with one of the members of the group, who occasionally asked for my opinion on stem cell related topics and told me about several disgruntled patients, but other than that I didn’t give Regenetek or Mr. Broeska much thought at all.

A few weeks ago I was alerted to the fact that the Regenetek Facebook site and related webpages had been taken down, along with Doug Broeska’s business profiles on the LinkedIn website. Soon after, an article appeared in the Winnipeg Free Press detailing Mr. Broeska’s alleged web of deceit (click here). Among the article’s findings were that “Dr. Doug’s” claims of earning a PhD at the University of Manitoba could not be confirmed (the University had no record of his graduating), and that another of his claimed degrees came from an institution called Brightland University, which apparently doesn’t actually exist, and is only part of the University Degree Program, an online degree mill that operates dozens of sham institutions. Furthermore, Broeska had claimed that he was a member of the International Cellular Medicine Society (click here), an international stem cell research oversight organization, but the executive director of the ICMS could find no evidence of Broeska’s membership. It had also been claimed that Regenetek’s clinical trial was being run under the direction of several Institutional Review Boards (IRB’s), which are governing bodies that ensure the validity of medical research efforts. No record of any legitimate IRB approvals could be found, and one of the organizations cited by Broeska as overseeing the Regenetek clinical trial was found to be headed up by one of his business partners.

Additionally, Broeska often boasted that Regenetek was a not-for-profit corporation, and that the company actually helped subsidize the cost of patients' treatments, for which the patients themselves paid up to $45,000 US. While Regenetek is indeed registered with Canada as a not-for-profit entity, most of the patients sent for stem cell treatment in India paid their fees to another Broeska owned company, CliniCard, which is a for-profit corporation (click here). Allegations have also been made that Regenetek paid patients that had gone through their stem cell protocol to recruit other patients, and to post testimonials and videos on Facebook and YouTube.

Perhaps worse than all of Broeska’s alleged falsehoods and financial sleight-of-hand were his practices involving many of the patients with whom he dealt (click here and here). According to reports, patients were threatened with being kicked out of the Regenetek clinical trial if they questioned any of the claims or methodologies used by Broeska after they returned from India. Broeska repeatedly stated that virtually all patients undergoing the treatment protocol in India saw “curative effects”, and that many had “returned to complete health without symptoms” (click here). Patients who reported little or no benefit from the treatment were accused of working for competitors, or otherwise having ulterior motives, and were booted out of the Regenetek study. Upon returning home, most patients received little if any follow-up, despite their supposedly enrollment in an ongoing clinical trial. Broeska was known to spend hours emailing and even Skypeing with prospective clients, befriending them in an effort to convince them of the validity of his claims and of his expertise in stem cell research, and ultimately to sign them up for treatment in India, to the tune of tens of thousands of dollars.

Regenetek partnered with an Indian firm called Genesis, whose Chief Operating Officer is an IT professional named Surjo Banerjee, that oversaw the medical procedures performed at a hospital in Pune, India. As previously stated, patients were charged up to $45,000 US for treatment (not including travel expenses), which consisted of CCSVI angioplasty combined with an infusion of stem cells derived from the patient’s bone marrow, in addition to intravenous and intrathecal (spinal) infusions of these same autologous mesenchymal stem cells. While in India, patients also underwent roughly 2 hours of physical therapy each day, purportedly to help the stem cells circulate to where they were needed. Perhaps not coincidentally, studies have shown that periods of intense physical therapy alone can markedly improved the functionality of many MS patienes, although the benefits fade after physical therapy is stopped (click here). Many of the claims and methodology used in what Regenetek dubbed the CTP (Combination Treatment Protocol) have been challenged by doctors familiar with stem cell technology (click here).

Due to the fact that so little actual follow-up was done on the approximately 70 patients who traveled to India for treatment, it’s impossible to quantify the actual effects of the treatment; suffice it to say that of the relatively few patients who have been heard from there are some who say they have seen sometimes dramatic improvement, and others who claim the CTP treatment to be a total failure. It’s impossible to objectively judge the veracity of subjective anecdotal patient reports, as any number of factors could contribute to the self-reported success or failure of any experimental medical procedure.

I will say by all accounts it does appear that Regenetek patients did receive some sort of stem cell therapy from licensed doctors while in India, effective or not; the scam that occurred lies mostly in the manner by which patients were recruited and then handled after they returned home, and in the financial shenanigans allegedly undertaken by Mr. Broeska and his colleagues. Unfortunately, because of the lack of any rigorous follow-up whatsoever, the actual effects of the treatment on the 70 or so patients who underwent the stem cell therapy will never be known, at least in any scientifically valid fashion. This is a real shame, for who knows what valuable lessons might have been learned if these patients had been properly assessed post treatment by qualified medical professionals?

As of this writing, the Indian company Genesis, which worked hand-in-hand with Regenetek until news of this scandal broke, is planning to continue offering stem cell treatments in India (at a cost of $16,050 US, as compared to the $45,000 charged by Regenetek), and even has plans to open a clinic in Trinidad despite the questions surrounding its offerings (click here). Patients who paid deposits to Regenetek but have not yet gone to India are demanding refunds, but thus far have had very little success getting any response. Posts have appeared on Facebook pages on which this matter has been discussed stating that representatives from Genesis or Regenetek will not be answering any inquiries posed on those sites. A Canadian doctor who worked closely with Regenetek has claimed she was “scammed” (click here). It seems that most of the players involved are now in serious “cover your ass” mode, and investigations into Regenetek by the Royal Canadian Mounted Police and other Canadian government agencies are now underway.

If any or all of the allegations made about Regenetek hold true, I hope all who read this will see this story as a cautionary tale about the dangers lurking in some corners of the world of alternative medicine. Distressingly, there are living, breathing human beings out there who somehow feel no guilt in taking advantage of desperate people with horrible illnesses. Back in high school I took an art appreciation class, most of whose content I don’t remember. I do remember, though, something that my art teacher, Mr. Rosen, once said: “Be careful, there’s human garbage out there…” Don't ask me what that quote had to do with art appreciation, but it sure was memorable, and quite apropos of charlatans who seek to profit from the desperation of sick people.


  1. Snake oil, it was prevalent in the old west and is still prevalent today. It's annoying as hell. I have friends, family, acquaintances who come to me with this "new amazing thing" that will most certainly cure what ails me. When in just a moment of contemplation I can clearly see that it's nothing more than snake oil...

    1. Yes, the well-meaning who come to us with all nature of "cures" can be bothersome, but they are only trying to help. Unfortunately, the average person out there has neither the training or inclination to separate facts from fallacy, and thus we have a handful of people making fortunes off of the misfortune of desperately ill patients seeking reason for hope. As you note, this certainly isn't a new phenomenon, and I'm sure it won't end anytime soon…

  2. Sadly, I fell for it, hook, line and sinker. I even read your prior post about stem cells and warning us not to go offshore, but I thought I knew better. An expensive lesson. Thanks for writing about this con man. Hopefully with all the negative press he's been receiving of late, when someone Google's his name for whatever venture he's involved in, it will save them.

    1. Kathleen, I can only imagine that Mr. Broeska will be facing jail time if the allegations against him prove true. And don't feel bad for falling for his con, it seems he was practiced at the art of deception. I've said many times on this blog that it's vital to not let hope eclipse reason, but that's much easier said than done when faced with this dreadful disease…

  3. Hi Marc,
    My last two doctors were fully invested, in something. From one, “But you have to be on something!” The other offered “To make you feel better” With decent drug company money flowing to them, both seemingly working on volume, hardly any questions asked or entertained. Running on automatic? All a common story, and pocket change compared to current and coming exotic stem cell services. And I’d peg the over/under on travel agent cousins at 1.5 for the Canadian crew, and take the over all day long…
    Thanks for all the work, much appreciated.

    1. Tom, please, don't get me started on pharmaceutical companies paying doctors to distribute their wares. How on earth is this legal? I used to work in the music industry, and there are still people in jail for something called "payola", the practice of paying DJs to play records on the air. So, paying someone to create hit singles is worthy of jail time, but paying doctors to push medicines is not? Something is wrong with that picture…

  4. Replies
    1. You're welcome. I certainly hope you didn't stay sober for long… Only kidding, don't mean to be pushing drunken debauchery. Well, maybe just a little…

  5. Thanks for this - great reporting. I listened to an audio of Doug on; January 7, 2014, Hosted by Tim Manson. There is annoying advertising at the beginning but if you persist around minute 14 Doug B. starts talking about how they do the procedure - there is not a lot of science in what he is saying. He also says there are 40-50 clinicians to every patient. Hope you take the time to listen to it and ask qualified doctors if what he is saying is even possible.

    1. Hi Flo – to say that there is not a lot of science to what he is saying is quite the understatement. I listened to Broeska's first segment, in which he describes that his stem cell protocol addresses the root cause of MS, and I had to stop. If the root cause of MS was known, we'd all be dancing a jig before you know it. I'm familiar with the research that Broeska was referring to, and it was all done on mice. The mouse model of MS is notoriously horrendous, and treatments that suppress it have a very very low translation rate when applied to humans. Let's put it this way, studies have found that saltwater, yes, saltwater can cure the most widely used mouse model of MS. I also know for a fact that almost everything Broeska said about his company is either completely false or a gross exaggeration. Sorry, but I wouldn't subject a qualified doctor to his drivel.

      That said, please don't think that this is indictment of stem cell research in general. There is a legitimate research being done on stem cells in MS patients, and there is much reason to hope that this research will lead to paradigm shifting treatments in the not-too-distant future. But a suggestion that regenerative stem cell therapy has been proven to work on MS patients right now is, to put it politely, horse hockey.

  6. Thank you for another thoughtful post. Your blog is the best written and best researched thing out there and is a great asset to MS patients (I was diagnosed PPMS in 2003, as you were). Do you have thoughts on “stromal vascular fraction” or SVF, which is made by enzymatically liquefying the fat tissue and spinning it through a column to isolate just the cellular “stem cell” part of the fat? It was featured on an NBC Nightly News segment in December ( and there seem to be enough practitioners that the FDA is starting to take notice. It's very hard for a layperson to distinguish legitimate non-HSCT stem cell researchers like Tisch and the Cleveland Clinic from scams, as Regenetek seems to be.

    1. Hi Neil – thank you for the extremely kind words about my blog. I certainly hope that they are even half true. Very sorry to hear about your diagnosis…

      As for SVF, I don't think anyone can say for certain whether or not the cells derived are efficacious. I think a lot would depend on how the cells are treated after acquisition from the patient. The number of stem cells typically derived from adipose (fat) tissue is quite small, and I wouldn't think they would have much effect if immediately injected back into the patient. If they went through expansion in a laboratory, a process that would take days if not weeks, and were grown to numbers in the tens or hundreds of millions, it's conceivable that such cells might have some effect.

      It seems to me that many of the clinics offering SVF therapies are doing so to get around FDA rules prohibiting "excessive manipulation" of autologous stem cells. I know that there are some claims that the other tissues and chemicals contained in the adipose material might also have therapeutic properties. I don't think any of that has been proven, either.

      As for distinguishing between legitimate stem cell research and scams, in general legitimate clinical trials do not charge patients to participate. Although I wouldn't term all medical tourism sites as scams, since I believe many of them do provide the services they claim to offer, I also don't believe the extravagant claims they make for their treatments, either. As I've said before, if the researchers and doctors involved were actually seeing the results claimed, they would be getting their tuxedos pressed and clearing off their fireplace mantels in anticipation of receiving their Nobel prizes. Any legitimate researcher should have a paper trail of published research. Ask whatever center you are considering to provide you with a list of the researchers under their employ, and then do some googling. If you don't come up with much, chances are you are being bamboozled…

  7. sad, but not surprising. as with everything else, buyer beware!


  8. Hi Marc,

    I just found the following website in relation to stem cells:

    The company uses fetal stem cells, and the website shows some very impressive videos of treated patients.

    I was wondering if you've heard of them and if so, what are your thoughts?

    Thanks for doing all that you do for the MS community.

    Debbie Dove

    1. Hi Debbie, thanks for commenting. I have not heard of "Stem Cell of America" before, and quite frankly I'm alarmed hat what I see on their website. All stem cell procedures are experimental, but the use of fetal stem cells is extremely experimental, as most of the current research has focused on the use of adult mesenchymal stem cells. Previous attempts at using fetal stem cells in patients has led to cancers, and the use of fetal stem cells in human test subjects is currently illegal in the US. As for the patient videos, take them with several huge grains of salt. Anecdotal evidence should always be looked at with much scrutiny, especially when presented by companies that are for-profit operations. As I've stated before, if these companies were actually achieving the results they claim, their scientists would be getting ready to receive their Nobel prizes. I'd be willing to bet that "Stem Cells of America" wouldn't even divulge the names of its researchers, and if they did those researchers wouldn't have any kind of paper trail attached to them. I have three words: CAUTION! CAUTION! CAUTION

  9. Marc, I remember you from the CCSVI blog. I actually went to Standford and saw Dr Dake right before the "stent migration" disaster. I was exploring tonight info on multipotent stem/stromal cells because I am ready to plunk down $4,000.00 to be in a "Clinical Trial" in Stevensville, MT. On Friday the 20th. Think I need to cancel the MRI & my "treatment". Have been really questioning my decision. But I am well aware of your extensive research into all thing's related to "New for Multiple Sclerosis". Me too, and I thought I had found it. But after reading the "Purpose of the study" It seems the study is : Summary
    Purpose of study is to determine safety and efficacy of use of autologous Adipose-Derived cellular Stromal Vascular Fraction (AD-cSVF) suspended in Normal Saline and delivered via intravascular system of quality of life and alteration of documented Muscular Sclerosis (MS) and related neurodegenerative patients. It is believed that the heterogeneous cell population which includes multipotent stem/stromal cells are capable of immune modulation/inflammatory modulation properties. Exam of disease progression and quality of life changes will be evaluated.

    1. Honestly, I think you should follow your instincts and NOT do the trial. As a general rule of thumb, you should NEVER paid to be in a clinical trial. Legitimate clinical trials do not ask their participants to pay to be in them.

      There's very little evidence that adipose derived stromal stem cells are of much use to MS patients. Not sure what your disease status is, but if you are still experiencing active inflammation (in the form of relapses and/or enhancing lesions on your MRI) I would seriously look into HSCT. It's not an easy treatment to go through, but it could put your disease into long-term remission (on the order of at least 7-10 years).

      Wishing you the best, and remember, discretion is the better part of valor…

  10. I am not familiar with HSCT. Can you tell me where yo look for info.
    I have a call into the Institutionsl Review Board and missed thier call back. I will try again in the AM. By the way here is the trial info.
    Neurodegenerative Disorder
    Robert W. Alexander, MD,DMD,FICS

    1. HSCT is the MS treatment that is similar to the bone marrow transplants given to patients with blood cancers. Chemotherapy drugs are used to completely wipe out the immune system, and then stem cells derived from bone marrow are infused back into the patient to "reboot" the immune system. As I mentioned above, in properly selected patients (those with active inflammation) this treatment can put multiple sclerosis into long-term complete remission. This treatment is gaining traction even with mainstream neurologists, but it is expensive (at least $50,000, and can cost over $100,000 at certain centers). I've written extensively about HSCT in previous posts, which include lots of links to abstracts and studies. Just search for HSCT in the search box at the top left of the blog.

      There's also a lot of information about HSCT all over the Internet, but be careful as some sites make claims for the treatment that are unsubstantiated, primarily that it can help all MS patients, even those progressive patients that display no inflammation. These claims aren't backed up by any current research, but there is some evidence that some members of the progressive MS population can benefit from the treatment.

      As far as the trial you were considering, like I said above, I don't know of any legitimate clinical trial that would require patients pay to be included in the trial. If you are considering regenerative stem cell therapy, I would recommend you find treatment centers offering mesenchymal stem cell therapies, such as Celltex. I'm not endorsing Celltex, but their approach at least has some scientific validity behind it. Keep in mind, all of these treatments are still unproven, and regenerative stem cell therapy in general is in its infancy. Any patient considering such therapy must be aware that a single treatment will likely not resulted in any type of lasting results, and that multiple therapies will be necessary to maintain whatever benefits might be achieved, if any.

      Like I said, if I were a patient with active inflammatory multiple sclerosis I would be very aggressive in seeking HSCT therapy. This, despite its high cost. The UK has recently added HSCT to its list of approved therapies, but only for patients with signs of active inflammation. There are several centers in the US currently conducting clinical trials of HSCT, and some centers do provide the service, for a fee, that patients outside of trials. In addition, there are many, many offshore sites now offering the treatment, as it's becoming a popular treatment for medical tourism. Much care should be taken in choosing a treatment center, though, as this is a very serious endeavor with many possible complications if not done right and in the proper setting.

  11. I really appreciate your answer and suggestions so I have put off having any procedure anywhere until I research further. I bumped into this 2012 article while researching Govenor Perry's personal experience with stem cell therapy.
    Perry’s association with Celltex goes beyond the traditional relationship between a patient and the clinic that treated him.

    You see, Perry seems to be buddies with the leadership of Cellex including Dr. Stanley Jones and David Eller. Perry was one of Celltex’s biggest boosters and there is little doubt that Perry’s backing helped the clinic. He also pushed for the Texas Medical Board to adopt rules that benefitted Celltex.

    Unfortunately, Celltex ran afoul of various federal regulations governing medical treatments, got audited by the FDA, and ultimately had to stop its clinical practice due an FDA Warning Letter (here). The FDA is still investigating Celltex to this day as far as I know and could produce some ill-timed news for Perry’s presidential hopes.

    Adding to the stem cell issues are Celltex’s mysterious stem cell operation now going on in Mexico, which may not reflect well on Perry either. There are more questions than answers about Celltex’s supposed Mexico operation, but the answers will come and they may be trouble for Perry.

    In the end, while stem cells were supposed to help Perry’s back injury, he may not be able to get stem cell issues off his back during a possible run for 2016.