What really happened at XCell-Center in Germany, formerly the largest stem cell clinic in Europe?
A baby died after receiving treatment there. Why? Was the death in any way connected to stem cells? (update: note that since post originally went up, quite a few more patient deaths both a clinics and in clinical trials have been reported.)
A commenter on a recent post of mine on reports of the possible deaths from stem cell interventions in Germany of three politicians from the Philippines, provided some fresh details on the now closed German clinic called XCell-Center. Whether the details are factual remains unclear at this time, but they might be.
The commenter even defended XCell and said it had gotten a “bad rap”.
The commenter, named XCell-Info, had this to say about XCell, showing some apparent very detailed, in depth knowledge of the place and their practices:
The XCell-Center primarily used autologous CD34+ stem cells from bone marrow. The cells were spun out (not expanded) in a certified GMP lab. Very few MSCs are found in the bone marrow.
To set the record straight, that particular patient died neither from stem cells nor from their injection. The death resulted from bleeding that was caused by the neurosurgeon while attempting to surgically open a brain ventricle blockage. Stem cells were never injected into that patient. Even though brain injections represented a tiny fraction of procedures performed at XCell, I strongly disagreed with their use and my opinion on that remains unchanged today.
The vast majority of patients were treated systemically and/or intrathecally depending on their particular disease or disorder. Some were treated via cardiac catheter by a licensed, experienced cardiologist in a cath lab, the standards of which, along with the rest of XCell’s treatment facilities, met or surpassed those found at US facilities. Many orthopedic conditions were treated by injecting the cells into the affected joint(s), a procedure not unlike that XXXX US orthopedists routinely use in the US today.
Despite the bad rap the XCell gets from reporters, bloggers and certain patient forums with axes to grind, for the most part, XCell did nothing more than treat patients with their own bone-marrow derived stem cells under pristine lab conditions in world-class treatment facilities.
It goes without saying that their upper management left a lot to be desired, to say the least. However, at least in my somewhat more informed opinion than almost anyone else, XCell does not deserve the categorical bad rap it routinely gets unless one believes that no patient should be treated with their own bone marrow-derived stem cells for things like arthritis, MS, heart conditions, knee problems, COPD, etc.
The “XXXX” is an edit by me to maintain consistency with our blog policy. I thought readers would find many aspects of this comment interesting. Reactions?
I for one am not convinced that XCell got a bad rap, but it is important to get as much detail as to the facts of the case as possible.
Is the comment above factual? Frankly, I’m not entirely sure at this point and am looking for more information. What do you think?
My wife attended X-Cell Centre in March 2011 and received an autologous stem cell transfusion with the stem cells introduced via a drip in her arm. Prior to the treatment she had suffered 4 CNS strokes (cerebral vasculitis) and had no mobility and extremely poor verbal communication skills.
After the transfusion we returned home to Australia, and with support from a physiotherapist and speech therapist, she has regained moderate to good speech and can now mobilise with the assistance of a walker for short distances.
Her specialist (an immunologist at a large private hospital in Brisbane) has agreed that whilst she would have shown some improvement, the improvement to date far exceeds what he considers would have been possible without the treatment.
I agree that X-Cell had problems from an administration perspective … I found it quite frustrating dealing with them remotely from Australia. However from a purely medical treatment perspective I found them to be professional, more than happy to answer questions (in English), and we were provided with full document including copies of CT and MRI images, and full documentation of the treatments performed, and lab results.
I can’t comment on the various stories, or other patients, but felt that a personal post might provide some balance to the posts previously made.
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Dr Cornelis Kleinbloesem still runs a business carrying out the same treatments in country’s more sympathetic than Germany. http://www.cells4health.com/
InsideXCell – Perhaps as your name implies you have inside information. This article and many others like it carried the story that the founder of X-Cell, Dr Cornelis Kleinbloesem, was accused of stealing to fund his lavish lifestyle. Has there been any new developments as far as criminal charges or civil lawsuits? I haven’t seen any follow up so I honestly don’t know, but this kind of headline and story don’t say much for the founder’s character if true.
http://www.telegraph.co.uk/active/9367208/Founder-of-XCell-stem-cell-clinic-accused-of-stealing-to-fund-lavish-lifestyle.html
I was really looking forward to answers to Barb’s last questions pertaining to Kleinbloesem. Please don’t stop now, InsideXCell…
Apparently InsideXCell doesn’t care to respond. I also asked what his or her interests in X-Cell were and got no response. It will be telling to see whether or not this person responds to Paul’s request to provide a real e-mail address.
InsideXCell has now responded, but I am communicating with him/her about some aspects of their comment before I can decide whether to post it.
Curious to hear InsideXCell’s response.
So is that the end of it then? I was really interested in hearing InsideXCell’s response and see what other information came out of this discussion.
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XCell-Center provided patients access to their own stem cells. These cells were processed in a certified GMP environment and administered by licensed, specialist physicians in a sterile environment.
Whether or not patients should be given such access before safety and efficacy data is published is a valid question. I believe Dr. Knoepfler advocates that safety and efficacy should be proven before any cell-based therapy is offered commercially. Seems Ms. Hansen is leaning in the same direction. Perhaps she can share the safety and efficacy data published by other “dubious” off-shore clinics before they started offering patients access to their own stem cells or even afterwards? I can’t seem to find anything more than a smattering of press releases and videos from “patients” claiming what some might call “miraculous” improvements.
InsideXCell – You missed my point. The X-Cell website claimed they were doing studies and they claimed a high rate of success treating everything under the sun. I am critical of any clinic that makes such extraordinary claims when there is no evidence to back it up. If a clinic isn’t doing studies, then don’t make such claims. It’s misleading and deceitful. Testimonials are one thing, but there were press releases giving actual figures such as 87% of patients with XXX have had noticeable improvements.
I do not believe that proof of efficacy is something that must be established. By doing that, it could take decades and many patients who could be helped will deteriorate or die. I do believe that safety is very important and at this point there is quite a good bit of published data showing that autologous stem cell therapy is safe. I already mentioned that I don’t believe that the deaths at X-Cell had anything to do with the stem cells. Having said that, I will not hesitate to call any clinic out that gives false information on their website or directly to patients who inquire about treatment at their facility. I have called out quite a few clinics besides X-Cell.
It’s so simple to be honest. X-Cell failed miserably in that category.
I don’t know Brian Sanderson but evidently he and I need for you to tell us where the published study results can be found since you seem to be a supporter, former owner or employee, or somehow connected to X-Cell. If you can provide the information then that would go a long way to settle this matter for me.
Without XCell-Center having published any peer-reviewed data how can you or anyone else possibly make a statement like: “Many went to X-Cell and the results were disappointing for the majority. “? You are doing exactly the same thing you accuse XCell-Center of doing. Where is your evidence?
Please provide data to support your claim. “I have contact with hundreds of patients” is not data. Otherwise, a simple “I don’t know.” will suffice.
Please provide a link to the “87%” press release. XCell-Center never made such claims regarding all of its patients. It did publish limited data on very small patient samples. It was very made very clear the numbers of patients involved. If you have evidence to the contrary, please share it.
I think you are able to do an internet search as well as I can. Unfortunately (or should I say fortunately), the XCell website is no longer available with its bells and whistles and patient testimonials. There are plenty of other articles and posts however. Here’s a video where the patient is told 80% see improvements.
http://www.telegraph.co.uk/health/healthnews/8083001/I-travelled-in-hope-to-stem-cell-clinic.html
Here’s a more recent update about the founder. http://www.telegraph.co.uk/health/healthnews/9192157/Stem-cell-clinic-that-preyed-on-the-vulnerable.html
Here’s a post I made in 2010 on the SCP forum:
09-19-2010, 01:42 PM
barbara
Pioneer Founding member
” I did find that back in 2007, Dr. Kleinbloesem was indicating that he would be doing some clinical trials very shortly. It will soon be 2011 and I couldn’t find anywhere that any trials had begun. I tried to find more on the study in Crete, but the links always come back to the X-Cell site. One of the trials is supposed to be for CP. There are mixed feelings on the boards about whether treatment did anyone any good. I did find that some patients featured in the Patient Stories were also the same ones that did a lot of posting (cheer leading I should say) on the boards. Is this a good or a bad sign? You be the judge. It is very easy to plant paid people on boards and forums.
My conclusions after reading all I could stand are that this clinic is masterful at recruiting patients, writing press releases and maintaining an image of scientific integrity when there really isn’t any. The odds of seeing a few bodily functions improve with this type of therapy aren’t that bad, but actually reversing disease or having an sci patient walk again, I just don’t buy into it.
Here is a statement from their site promising clinical studies by this year:
The XCell-Center combines clinical expertise with scientific research.
For 2009 – 2010, we plan to initiate two international clinical trials, one for Spinal Cord Injury and the other for Cerebral Palsy.
In 2009, we’ve commenced a study in cooperation with the University of Crete: “Stem Cells in Diabetes Mellitus Patients with Limb Amputation”.
In addition to clinical trials, we also perform pre-clinical research projects
These projects involve second and third generation stem cells. Second generation stem cells will enable us to multiply mesenchymal cells (multiple treatment option). Third generation stem cells will allow us to target specific cells (multiplied targeted progenitor cells, f.e. progenitor neuro-cells).
These projects are developing in close collaboration with Neuronax and the University of Clermont Ferrand in France.
___________________________________
After a couple of years of continued hype about studies on their website, recycled patients telling the same success stories and patients that I had contact with not getting the results that their website touted, there simply is no factual evidence that they were getting good results. Enough said. I simply cannot defend a clinic that engages in deception. Apparently, no one else but you can either.
Despite your “David Blaine-like” attempt at misdirection, let’s first get back to the original points:
1) Please provide a link to the press release you quoted.
2) Please provide credible, verifiable evidence that supports your claim that the majority of patients treated at the XCell-Center were disappointed with their results or retract your statement and confirm that you actually don’t know one way or the other.
After we’ve resolved these issues, maybe we can move on to some others.
InsideXCell,
If you are going to continue commenting here, I need a way to contact you such as a real email address, which I will of course keep confidential. Contact me.
Paul
The Internet never forgets. You can access historical archives of XCell’s web site via the Internet Archive. Here’s a link to the last useful version of that site captured by Internet Archive: http://web.archive.org/web/20110226023207/http://www.xcell-center.com/
Thanks Bill – Here’s a survey X-Cell supposedly conducted. I took it from the website you provided. 95% (even higher than I thought) rated their care good or better and a whopping 100% would return and recommend X-Cell to others. The website states “Excellence in patient care is paramount to our overall success at the XCell-Center.” Anyone reading that would, I believe, think that X-Cell was producing results. If they weren’t then why would a patient return or recommend them?
Our 2009 Patient Satisfaction Survey Results
Satisfaction Survey from 140 English Speaking Patients
November 2009
Excellence in patient care is paramount to our overall success at the XCell-Center. From the time each patient contacts us until they return home safely, every staff member continually strives to exceed that patient’s expectations.
In our recent patient satisfaction survey, our patients acknowledge that we are surpassing our patient care goals.
Overall
The vast majority of respondents rated their overall experience in Germany quite highly. About 70% rated their overall quality of care as “Excellent” and more than 95% rated their care “Good” or better. Every patient surveyed indicated that they would return to the XCell-Center again and that they would recommend treatment at the XCell-Center to their friends.
I’m not so sure Xcell operated at the high level of physician practice claimed. As an example, one one of their web pages they showed someone getting an intradural injection of cells, but the procedure was blind. So while the room looked all Euro snazzy, using a blind placement procedure would be substandard in the U.S. for many reasons. The first and most obvious of which is that you have no way to confirm that the cells are actually likely to get to the CSF in the brain. We’ve seen many instances where moving the needle a mm or two can greatly enhance contrast flow. So in this instance, a minimum standard of care for the U.S. would have been the use of a c-arm fluoroscope with contrast.
Dr. Centeno, I was not aware that the United States had an established standard of practice for the intrathecal administration of unexpanded, bone marrow-derived CD34+ stem cells? If that is the case, could you please elaborate on the details. Do you have any idea how many doctors performed this procedure in the US to this established standard between 2007 and 2011?
It’s difficult for me to comment about a picture I haven’t seen so before I do, could you please provide a link to it? Once I’ve had a chance to see it, I’ll be happy to comment.
XCell certainly deserves some of the criticism it has received. However, it did separate stem cells from bone marrow in a cGMP facility. What other offshore facility does that? It did employ licensed specialists in orthopedics, cardiology and neurology. It did administer stem cells under sterile conditions in a very modern hospital setting that included MRI and CT scanning. It did actually treat people with the type of stem cells that it claimed and it did administer those cells as claimed. Any criticism directed at physician training, using “real” stem cells, etc is misguided and thus a “bad rap” in my opinion. My intention is to inform the uninformed that, despite what some might say (even some who support autologous bone marrow-derived stem cell treatments abroad) the XCell center did not “scam” everyone who went there.
Did they publish the results of any of their treatments?
I’ve not been able to find anything in the peer reviewed literature but that may just reflect my inability… I’d be genuinely interested to find any publications, if they exist.
The short answer is no. This is something I think they should have done along with performing better patient follow-up in general. I cannot find any such publications from any other off-shore clinics either. I have found a handful of very small “case studies” but certainly nothing done to a scale that would show statistical significance. Perhaps this just reflects my inability as well…
Thank you for your response.
OK, in the interests of prompting more information about XCell-Center, I’m going to explain why I opted to go elsewhere.
(1) I couldn’t find peer-reviewed publications by their doctors.
(2) They were treating such a wide range of diseases… Improbably many birds with one stone.
(3) The way they presented patient outcomes smacked of too much hype.
These were my impressions based upon their website. I never got as far as actually corresponding with them.
So, if anything I said above is sufficiently wrong, I hope someone will come foward with information about XCell-Center in order to correct me.
Brian – My sentiments exactly. I am co-founder of the Stem Cell Pioneers and am undoubtedly one of the “patient forums with an axe to grind” mentioned, however, I have no axe to grind with X-Cell for any other reason that what Brian so aptly states. If thousands of patients were being treated so successfully and studies done as advertised, then surely the scientific world would have been abuzz about it. I have contact with hundreds of patients. Many went to X-Cell and the results were disappointing for the majority. The hype on their press releases was almost embarrassing to anyone with any knowledge of stem cell therapy. I will say however, they knew how to sell patients on their treatments. Excellent sales force!
I don’t believe that the stem cells themselves were in any way the cause of the deaths, however, a clinic that engages in risky procedures or medical malpractice deserves a bad rap. Those involved in X-Cell have only themselves to blame for what happened. Reporters, bloggers and patient forums were not the cause of its demise. Let’s put the blame where it’s due.
Without Xcell-Center having published any peer-reviewed data how can you or anyone else possibly make a statement like: “Many went to X-Cell and the results were disappointing for the majority. “? Please provide data to support your claim. “I have contact with hundreds of patients” is not data. Otherwise, a simple “I don’t know.” will suffice.
I know some of the patients to begin with. Also, do a simple internet search and you will turn up a lot of disgruntled patients. Start with Ripoff report, Neuro Talk, Care Cure, Stem Cell Pioneers. Do you still have a stake in the clinic? With thousands of patients supposedly treated successfully, then you should be able to produce some type of proof yourself. Are you now stating that you simply don’t know if anyone got any improvements and that patients were duped by the statements claiming that legitimate studies were being undertaken and that results would be published? Is there some reason, you are not posting under your real name?
You are the one making the claim that the majority of patients who were treated at the XCell-Center experience disappointing outcomes. You still have not provided any credible evidence to support that statement. I will not fall prey to you sophomoric attempts at misdirection and changing the subject. So, please provide credible, verifiable evidence to support your claim or please retract your statement. It’s really as simple as that.
Any doctor who commits medical malpractice should be punished. I think everyone can agree on that. Keep in mind that a couple dozen or so “brain” procedures were done by more than one neurosurgeon and only one of them was accused of any wrongdoing.
…and by the way, who gets to decide what constitutes a “risky” procedure? You? Me? The FDA? Shouldn’t this be a decision to undergo any medical procedure be made between a patient (or minor patient’s parent) and his or her licensed physicians? Someone like Dr. Knoepfler might say that administering autologous bone marrow- or fat- derived stem cells to any patient systemically or into ANY organ is “risky”. Perhaps he should get to decide? What do you think?
Well….?