For years I’ve been writing about fat stem cell clinics that sell non-FDA approved stem cell “treatments” to vulnerable patients right here in America.
These clinics have been sprouting up like mushrooms across the US and their numbers may be above 200 today overall. As a result perhaps it was inevitable that one would arrive in a locale near me.
Tomorrow, July 11, reportedly the Irvine Stem Cell Treatment Center will open a Sacramento, CA branch. The doctor there will apparently be Thomas A. Gionis (picture from press release). This private, for-profit clinic has no affiliation with UC Davis School of Medicine in Sacramento where I’m located.
The stem cell clinic Sacramento branch will sell transplants of fat stem cells in the form of something called stromal vascular fraction or SVF, which I believe is almost certainly a drug. To my knowledge this clinic and the large chain that it belongs to called Cell Surgical Network (CSN), do not have FDA approval to use SVF.
Both publicly and to me on this blog, CSN continues to argue that it doesn’t need FDA approval (here, here and here), but recent FDA draft guidances sure suggest otherwise in my view. Of course if the FDA never takes action on the use of SVF then how are we all supposed to interpret that? Without FDA action or finalized guidelines, is it formally possible that the FDA could back down on SVF?
This clinic will reportedly sell SVF to treat a dizzying array of conditions having nothing to do with fat:
“Emphysema, COPD, Asthma, Heart Failure, Heart Attack, Parkinson’s Disease, Stroke, Traumatic Brain Injury, Lou Gehrig’s Disease, Multiple Sclerosis, Lupus, Rheumatoid Arthritis, Crohn’s Disease, Muscular Dystrophy, Inflammatory Myopathies, and Degenerative Orthopedic Joint Conditions (Knee, Shoulder, Hip, Spine).”
To me as a scientist the use of SVF to treat all these very different conditions does not make good common sense.
It would also seem arguably to be quite likely be considered “non-homologous use” by the FDA, a standing that would also automatically make this a drug requiring FDA pre-approval. Non-homologous use means using a biological product of a certain kind that is not homologous (not the same or similar in origin) to the tissue being treated. For example, fat is not the same as the brain or other central nervous system tissue that is involved in several of the conditions on the clinic menu. Same goes for cardiac muscle, airways, etc.
The use of a non-FDA approved product in a largely non-homologous manner increases risks for patients. Note that these stem cell transplants are also very expensive with little evidence in the way of published data of benefit.
The CSN stem cell clinic in Sacramento will be located at the New Body MD Surgical Center, just about 10 minutes from my office. I plan on paying them a visit at some point. Let’s see how that goes. Will they let me in?
I had a stem cell treatment for my cardiomyopathy in June of 2014 and I have improved by 20%. My EF (ejection fraction) was only 30%, and my last echo confirmed it at 50%-55%. Dr. Gionis used fat from my hip. I don’t understand why this has happened to a Doctor that literally saved my life. I’m sad to see that his world has been turned upside down by this FDA ruling. During my treatment, there was another patient that had COPD and he had improved so much that he could play with his grandchildren.
Dr. Gionis saved my life and I am forever in his debt.
@Chris Centeno
I have read much on your homepage and I would like to read more about your methods. What kind of cells do you use? Do you use the PRP-method, too?
We use only bone marrow with a proprietary lab based same day isolation method for the same day BMC procedure.
@Chris
“On the former, we’ll soon be submitting an n=2,300 complications paper (the largest of it’s kind) with 5 independent reviewers adjudicating the complications collected in a registry over 9 years”
Great to hear this, please let us know, when this article is published. I would like to read it.
@Paul
maybe you could write an article about this paper, I am sure many of your readers are interested in this article, too. Maybe it will be a great step for the stem cell based medicine, which could help us to talk about facts and data and maybe to judge the one or other stem cell application.
@Christian Sure, the paper is written, just going back and forth in pre-submission editing now. It compares complication reporting and adjudication in cultured cell recipients to BMC patients for ortho use. We randomly recruited 5 physicians off LinkedIn who we didn’t know to serve as independent reviewers who were asked to adjudicate SAEs in a blinded fashion. As you know, it may be between 6 months to a year before it gets published.
@Chris,
I’m very interested to read that paper when it comes out.
How does one randomly select physicians off of LinkedIn? It seems like it could be somewhat non-random and that it would be preferable to have an independent body do the selection of the reviewers.
Paul
@admin, random likely wrong word. We asked for physician reviewers and took the first 5 qualified and willing that responded with whom we have no connection nor relationship.
On adipose clinics, I have yet to see much data from US clinics. Jae Woo Pak does a good job in Korea, but I expect no US clinic has built much of a registry tracking infrastructure to properly get data from patients. It’s expensive as we have customized software that we paid 150K to create, 3 FT employees who call patients, 1 FT employee who codes procedure types, 1 FT biostatistician, and a FT study coordinator.
The RCT are cross-overs at 3 months. So for example, for the rotator cuff patients are randomized to PT exercises or therapy and those who get PT can cross over at three months to the active group if they have had little benefit. So the control is a standard conservative therapy. While they won’t have the impact of a placebo trial, they are a big step up from publishing registry data. Each will cost us about 250K to complete as they are no charge to the patient, so not nutty expensive, but a great deal of money for a small clinic.
Amniotic products have traditionally been viewed at 361 tissues, but that goes back to the days where the only applications were wound coverings or dural repair. Since then the companies in the space have figured out that calling them stem cell products (this is done informally by reps speaking with physicians) dramatically increases sales. Regrettably the physicians have no mechanism where they can test these claims and are frankly ignorant enough to buy the sales pitch which they then parrot on web-sites. The companies usually avoid making any formal claims about cell content, knowing that if they did this would cause FDA to reclassify as a 351. 361 requires only registration with no IND and no clinical trials.
Thanks for the clarification and the info, @Chris.
Do you think the adipose clinics generally don’t do this kind of clinical research simply because they want more profit?
As discussed, collecting data from patients on an ongoing basis in a clinical registry is extremely expensive. I think clinics tend to fall into one of two categories. Some of the smaller clinics that I have spoken to claim they have no expertise in data collection nor publication. Others know they should be collecting data and publishing it, but it is clearly all about the money. I remember 1 orthopedic guy from many years ago who refused to join the ICMS data collection effort because of exactly that rationale. He’s now been doing this about 7 years and still hasn’t collected any significant data and the little bit that he has presented seems very unlikely to be credible. So in summary, this is a huge issue that needs to be corrected. In my opinion, if you’re working with an investigational technique you have an ethical responsibility to collect and report data. There are no excuses and money should not enter into that discussion.
@Chris Centeno
Thank you for your list and your published works. I am still reading them, it is very interesting.
@Chris, thanks for sharing details of your OA objective measures. Great that you have candidate biomarkers / theragnostics – hope those provide good correlations. One doesn’t often see dose-response reports in this field, so congrats on getting that score too.
Best, Wolf
@Wolff, we use a variety of validated metrics. For example, for the knee we use LEFS and WOMAC as well as NPS (numeric pain scale). We also add in a subjective % improvement as this is usually what patients relate to, but we report all metrics. On objective measures, when they are expected to change we will use those as well. As an example, for severe knee OA we don’t expect to see radical changes on knee MRIs other than an improvement in BMLs. Having said that, this hasn’t stopped us for looking for such an objective metric. as a result, the 5th study we have funded is examining various GF and cytokines levels present in the synovial fluid before and after a procedure with the goal of identifying markers that correlate with recovery (similar to existing equine OA studies). On the other hand, in indications like ACL tear where we expect to see changes in morphology of the ligament after a precise SC injection, we use MRI. As an example there, we recently had a study accepted for publication that used computer histogram density analysis of before and after MRI images of the ACL to better objectify changes. Another example is our rotator cuff tear RCT that uses 3D ultrasound volume inquisition (GE S8 protocol) to determine if objective improvements are being seen in the tendon. On dose, we have a paper that was recently provisionally accepted that found a nice correlation between dose and pain response in knee OA patients for a specific protocol of BMC.
@Chris,
Are you aware of any adipose stem cell clinic doing these kinds of functional measurements in patients?
Paul
@Chris Centeno – great that you could give up some time to post and describe your work. You address a key issue that provides direction for those asking what makes a stem cell trial credible or not and that is the “n”.
In the Nadal case and other press releases and blogs, we hear about spectacular recoveries from illness of single individuals (n=1). But we are not told if this treatment worked for anyone else. What if n=99 others had no benefit – then you would not call Nadal’s case a success for the therapy in general, but that Nadal’s recovery was an exception (maybe he was getting physio too, or he healed naturally, or he was taking other therapies, etc). But if a significant fraction of patients experience a significant benefit – then you can call it a potentially good therapeutic and it may become approved. Furthermore, “significant benefit” should be measured by robust means, such as blood chemistry, tissue biopsy, clinical assessment scores. Although patients “self-reporting” that they feel better is important, it alone cannot be considered an independent measure of therapeutic success.
Chris – what type of clinical measures do you employ and is there any way you can address the issue of whether the injected cells are causal for recovery, e.g dose-response? And best of luck with that n=2,300!
Thank you for this interesting discussion. There are already stem cell therapies which work and have a good outcome. I saw myself that for example the PRP-therapy could have an amazing outcome. The PRP-therapy healed the avascular necrosis of my brother. His bone was healed, even the damaged cartilage was ok after this therapy. I can only repeat myself, it was amazing.
@BioCurious
I am no expert and of course it is too much to earn a PhD-level just to judge a stem cell therapy.
But there are many experts writing in this blog and it could be a big help, if some experts let us know which stem cell therapy is already advisable/approved/could have a good outcome.
I can tell you my experiences about PRP, this is not much, but I hope some experts will help us to make a list about possible good stem cell therapies and maybe an other list about very dubious therapies.
It is good to be sceptic about new stem cell therapies, but I think you can not place them all under the same umbrella.
@BioCurioius,
thank you very much for your answer
@Paul and other experts
Please, all stem cell experts, help us to answer this question and to make a list about maybe good stem cell therapies
This would be the best to inform potential stem cell patients about what they may will do.
Since several people seem to be asking how to judge a stem cell efficacy study and/or therapy, I’ll give my opinion (which may not be very helpful). The only way to do this for YOU is to be able to understand and critically analyze the rationale, experimental design, and data from a particular study THEN come up with your OWN interpretation of the data. Notice I didn’t say the author’s conclusions. This is because the authors may have a conclusion that speculates slightly beyond what the results of the data do in fact demonstrate. This isn’t something only done by stem cell researchers/clinicians trying to sell a product, but is done in almost all biological fields, and is a way of pushing back the frontiers of what we understand as scientists. By making a strong interpretation of your data and generating a testable model, the rest of the field will (usually) take notice (if they haven’t already) and the model will be tested and eventually refined by several independent labs.
So, unfortunately, in order for any particular person to decide if a study or therapy is good for them, my suggestion/opinion is that they get a PhD-level (or MD + research) education. This is probably not an option for most, though, and the second best thing you can do (again, just my opinion) is to read through information and forums (like this one) to try and get as much information from people on both sides of the argument (and those who are neutral).
–>Richie,
These are the crucial questions and I hope Paul or anyone else could give an answer to this.
Paul and Wolf say stem cell medicine is not approved till today
Barbara says she believes in stem cell medicine and tells us about her own success and supports her view with some interesting studies.
We all can read about several stories about amazing recoveries in media.
There are about 200 stem cell clinics, I think they all won’t be the same.
And the big challenge is to differ between the big number of therapies. I think stem cell applications in orthopedy are some steps forward (just take a look in the literature posted by Barbara) … maybe.
I am a little bit disappointed, because our interesting discussion seems to stop at this point – the most interesting and crucial question.
How it is possible to judge a stem cell therapy and which stem cell therapy is already approved/successful???
I hope some of the experts will help us with some answers.
–>Paul, Wolf, Barbara, could you please help us with some more answers?
Thanks
Thanks Barb for alerting me about this thread. Yikes, I have to say that this could be the longest comments thread I’ve ever seen on Paul’s blog, so congrats to Paul to sparking an important debate. @Richie, we list our published work here: http://www.regenexx.com/about-regenexx/research-based-stem-cell-procedure/ . We list our collected data here: http://www.regenexx.com/regenexx-patient-outcome-data/ . On the former, we’ll soon be submitting an n=2,300 complications paper (the largest of it’s kind) with 5 independent reviewers adjudicating the complications collected in a registry over 9 years. On the latter, we’ll be updating all of our collected and on-line reported registry data again this fall as we do annually (or more frequently). Having said all of that, all of this is registry data, so it’s not perfect, but it does report all results that we obtain for a certain orthopedic disease state. To that end we have four RCTs that we have funded, with our knee OA RCT having just completed enrollment in Chicago and three open and enrolling RCTs in Colorado that are still recruiting.
On amniotic cells, The Interventional Orthopedics Foundation is testing all of these products right now. They took over a project we began in our lab last year that showed that the BioD product contained no living cells let alone living stem cells. That organization has now tested a second amniotic tissue product and again found no viable cells. They have more to test, but it seems likely that none of these products have much in the way of viable stem cells.
@Chris,
I appreciate you weighing in here on these issues. Do your RCTs include placebos?
Paul
@Chris, On the amniotic products, wouldn’t the FDA view such products automatically as drugs requiring preapproval? It seems that many of the organizations selling such products have no approval, IND, etc.
@Wolf
You give us one example, but there are many other stem cell applications with maybe other results. What do you think for example about the stem cell applications in orthopedics from Dr. Centeno? Why are his studies not enough evidence for you? I just ask, because I would like to learn, how to distinguish between a “good” and a “bad” stem cell therapy and maybe, how to choose a “good” stem cell clinic.
And I hope an expert would explain this to me.
For potential stem cell patients it is very difficult to distinguish, because some experts say: they are sceptically, because there is not enough evidence. .
and others say there are already some safe and approved stem cell therapies.
And in media you can see that some famous people really were healed by stem cell therapies like tennis professional Rafael Nadal. These examples are just only one case report, but a successful one.
How could a potential patient decide?
Please help us and give us a short advise.
Thank you in advance.
Barbara – that’s a good question and I hope I can provide a concise and understandable answer.
As Paul said there are very few publications by stem cell clinics and many have never carried out clinical trials to assess their therapies for safety (if there are near-term or long-term health dangers), efficacy (if it is really the stem cells that are affecting the disease beneficially) or mechanism (how the stem cells achieve a therapeutic effect). Usually clinical trials are done to answer these questions and avoid exposing patients to health risks.
We attempted to answer some of these questions by comparing the medical records of patients before stem cell therapy with their disease status afterwards. For example, in type I diabetes, we assessed patients’ insulin requirements and blood glucose control, as well as diabetes-related pathologies. In a 2-4 year follow-up, we found no improvements in any parameter that could unequivocally be assigned to stem cell treatment. We found just as many cases of improved control in those receiving stem cells as in another group that had not had such treatment.
Some patients had indeed hoped for a cure because they read articles and blogs about stem cell cures. Literature from some clinics misappropriates basic stem cell research results to promote this idea – an example from one clinic:
“Stem cells are separated from fat cells …stem cells return to patient’s body. Stem cells then rush and home to that injured area, and start turning into new tissue.”
“New stem cells are able to make new beta cells, the new beta cells are able to sense blood sugar levels and react accordingly”
The second line refers to research results in cell culture but if you don’t know that it is easy to assume that your fat stem cells are going to make new beta-cells in your pancreas. I’m glad to hear that you were given clearer expectations because many participants we interviewed (in Europe) felt misled.
If I can be of any further assistance, don’t hesitate to mail. Best regards, Wolf (wolfram.mardin@dcemail.com).
Barbara – thanks, intersting results, I will read it all.
Paul – you are so sceptic about stem cell therapies, Why are these studies for example the first one:
http://www.ncbi.nlm.nih.gov/pubmed/26089699
not enough evidence for you to believe in these medical applications?
I would like to learn, how to distinguish between a “good” and a “bad” stem cell therapy and maybe, how to choose a “good” stem cell clinic. .
Thank you in advance
Richie – I don’t know how you are searching. This list isn’t even complete, but there are 11 listed. You could contact Dr. Centeno’s office for more information. Why not contact Celling BioSciences directly as well? http://www.ncbi.nlm.nih.gov/pubmed?term=centeno%20c%20stem
Barbara, I just checked on pubmed, I fpund not only one study of Dr. Chris Centeno? For this discussion it would be helpful to talk about facts and studies and data. So please, if anybody can tell me, where I can find data of a stem cell clinic, please let me know.
We just talked about Celling Biosciences, Has this clinic published any data about there treatments?
I only mean data about treatment of humans. Of course there are a lot of studies but not as many data for human applications.
Paul,
do you know, where to find such publications of stem cell clinics?
200 clinics and I don’t find data about their treatment results? I can not understand this?
Thank you in advance
Many doctors feel that what they are doing is simply the practice of medicine.
Richie – There are lots of published studies. I’m not sure where you are searching, but doctors like Dr. Chris Centeno, publish a lot.
Actually there are very few publications by stem cell clinics overall, especially considering there are something like 200 of such clinics. This is a key way that such clinics are letting patients down. Paul
@Barbara
Do you know, if there are any data available?
Where can I find data from stem cell clinics?
Where can I find data from Celling Biosciences?
Please help us with some more information.
Thank you in advance
Wolf,
how can I differ between a good (approved) and a bad stem cell therapy?
There are so many stem cell therapies.
@Wolf, thank you very much for this interesting statement.
It is really disappointing that stem cell clinics seem to deny to publish their data.
Because exactly these data is what we and all potential stem cell patients are looking for.
´
I have an additional question. Tennis professional Rafael Nadal received a stem cell therapy and the amazing point is: Everybody can see that Rafa was healed, because he is back on the center court.
So this application seems to be a succesful therapy option.
Since this time I am looking for the exact details of his stem cell application, but nobody knows exactly.
Just take a look at this article and the discussion under the article.
https://www.ipscell.com/2014/11/tennis-star-nadal-to-get-dubious-stem-cell-treatment/
Do you may know more about this therapy? And what do you think about this therapy?
Thank you for your help in advance.
@zchick – my bad, apologies for getting the name of your clinic wrong and thanks for the correction, it was Celltex Pharma. However, I didn’t say that you had any financial interests in Celltex, nor have I tried to discredit your story, I am only too happy to hear any report of a recovery from MS.
Celltex has been mentioned numerous times on Prof. Knoepfler’s blog, especially after the FDA shut down their operations due to unapproved research on pediatric patients, thereby forcing them to move to Mexico.
My issue with organizations like Celltex pertains to clinical science and ethics – in that they have never demonstrated the “cures” they report were caused by therapeutic use of SVF (stem cells). They have not shown where these cells go, nor what happens to them or if they or their progeny are even present when patients reports recovery or a lessening of symptoms. Hence, it is not possible to distinguish between placebo, indirect psychosomatic, biochemical or physical effects and any real effects due to the stem cells themselves.
My colleagues and I have submitted a white paper to EMA, which retrospectively analyses fictive primary outcomes for construed trials including 650 patients who received autologous stem cells in clinics such as Celltex between 2009 and 2014. The data is based wholly on patient feedback as unfortunately none of the clinics were willing to participate. In short, there was no evidence that stem cell treatment achieves any significant therapeutic benefit over placebo in any indication (type I diabetes, juvenile arthritis, rheumatoid arthritis, Alzheimer’s, Parkinson’s, chronic back pain or multiple sclerosis).
You may say, so what if one out of 100 people are cured? Or 1 in 1000? But if 1 in 1000 dies – what then? While unregulated clinics cannot show a single case of proven effectivity due to stem cells, there are cases of death due to the procedures used, for example a clinic in Germany was shut down when a baby died after injection of stem cells into the brain. For those who are vociferously supportive of continued unregulated stem cell therapeutics, there are others who will never blog about their experiences. Between these poles, 99% of treated patients part with between $10,000 to over $100,000 with no chance of a cure. A factor most often omitted from the equation on unregulated clinics is the financial cost to patients.
@zchick, I do not hide behind a pseudonym.
Best regards, Wolf (wolfram.mardin@dcemail.com).
Wolf – Would you please explain what this means and why it would have any credibility?
“My colleagues and I have submitted a white paper to EMA, which retrospectively analyses fictive primary outcomes for construed trials including 650 patients who received autologous stem cells in clinics such as Celltex between 2009 and 2014. The data is based wholly on patient feedback as unfortunately none of the clinics were willing to participate.”
I’m also curious as to why you think patients who opt for treatment are expecting a cure. I’ve never been told to expect that, but I certainly have gotten quality of life improvements that I was unable to get with medications or any other conventional medical treatments.
Jennifer and Barbara, thank you for your interesting information.
Do you think the different therapy options of Celling Biosciences are already approved enough?
What do you think, Paul?
I know PRP is approved, but what do you think about the other applications?
Celling Biosciences isn’t a clinic. I agree with Jennifer – an apology is in order from Wolf.
About Celling Biosciences
Celling Biosciences is an Austin based company working closely with world leaders in academia, medicine, scientists and engineers to research and develop innovative technologies in the emerging field of regenerative medicine. Celling’s product-offering focuses on autologous adult stem cell therapy and the devices and services that compliment these procedures. For more information please visit: http://www.cellingbiosciences.com.
@Wolf No I’ve no connections whatsoever with CellingBio Science nor have I ever been treated there!? Not sure why you drew those conclusions? I have never received a free treatment anywhere, nor do I have any financial interests any stem cell clinics I’ve been treated in or anywhere else. I’m an adult stem cell advocate using my own personal story to give other disabled, sick, patients a chance at hope. It’s quite common for the industry to draw unwarranted assumptions when a patients shares their personal story. The easiest way to try and discredit a sick patients is to insinuate they must have something financial to gain by making my story public. I, as well as many of my friends have come up against this farce time and time again. It’s nothing new. (Not that it’s any of your business, but I’m happy to share) My treatments were with Celltex in Houston, Tx. for MS, Dr. Shine John with Austin Foot and Ankle specialists in Austin, Tx. for plantar Fasciitis, and then with Dr. Wade McKenna in the Dallas/Ft. Worth area for injured ACL. I’m thinking an apology is in order! And Paul knows I’m happy to share anytime, anywhere using my full “real” name. Many people I’ve come to realize, hide behind pseudonyms when posting comments. I have nothing to hide and everything to gain in helping others, by speaking up loudly for all those who are suffering from debilitating and cruel injuries/diseases/conditions. I’ll always be respectful and courteous and I’d never make a giant leap of an assumption toward anyone else. Thanks for your time and attention!
Paul, thank you, very interesting articles.
Bianca
Thanks for the thoughtful reply…it’s my first time posting here, but probably not my last. Some companies seem to be doing an OK job of vetting their product(s), but others, not so much. Then there seems to be a disconnect from the company and the end user (physician). I’m not really sure why this is (maybe $$$)…?
There do seem to be some promising results coming out of several academic labs (here in the US and abroad) using amniotic cells, but the commenters here seem pretty torn between supportive and not (I remain skeptically optimistic, haha). It does seem more safety/efficacy studies should be done (and done well).
I think you really nailed it with your last idea there “and whether the product really has any viable cells in it at all.” If not, it’s just ECM, debris, and buffer. This also raises an interesting question that, what if there are dead (necrotic and/or apoptotic) cells in the product? Would this be detrimental? Would it cause an adverse reaction or just get turned over in vivo? I guess time will tell if the FDA continues to allow these folks to operate (and under what classification, “homologous use” or as a drug) and whether or not any harm comes to the patient.
Cheers
I don’t mean to sidetrack the focus/discussion, so let me apologize in advance here, and I’m no stem cell expert, but from what I have read, amniotic cells/tissues are typically considered “safe” when compared to other allogenic cells/tissues, right?
I see a call for evidence in the comments, and from just a bit of reading I have learned that amniotic fluid stem cells express several “pluripotent markers” but are not capable of producing teratomas in mice (summarized in De Coppi et al 2007). Mice not = human tho, but the teratoma assay is a “gold standard”. Is there evidence these are NOT safe? You know what they say about absence of evidence, right? Sounds like these cells and tissues have been used historically for a long time now.
I also do not disagree on the categorization as “drug” or otherwise. Just interested in what you guys and gals think about this topic
Thanks, BioCurious, for the comment and questions. In general allogeneic products such as amniotic cells (coming from a different individual) are defined as drugs and require preapproval by the FDA if planned to be used in transplants. Many stem cell clinics do not get that approval. My sense is that the thinking behind requiring preapproval is at least in part that allogeneic transplants of biological products have higher inherent risks to patients including via immune reactions. There is some debate as to whether “primitive” stem cells have a lower tendency to spark immune reactions so that could be a factor in lowering risks perhaps if you buy that view. The other interesting possibility is to harvest amniotic cells, bank them, and save them for that future child for autologous use down the road should they need them.
Other potentially troubling issues pop up with supposed “amniotic stem cell” therapies including the source (was it ethically obtained with consent of the mother?), the preparation (a clinical-grade lab approved by FDA), and whether the product really has any viable cells in it at all.
Hi Jennifer, I think it would be fair and correct for you to declare your interests in “Celling Biosciences”, a for-profit-clinic for autologous cell therapies for MS, diabetes etc.
Just sayin’.
@Wolf and Jennifer, I wasn’t aware of any ties between Jennifer and Celling Bioscience. Are there?
@Wolf, unless you can provide some concrete evidence that Jennifer is in fact linked to that stem cell clinic, I’m going to have to consider taking your comment down.
Paul
To date, I’ve had 3 cell procedures, for three different conditions, using 3 different doctors. 1. 2012 MSC’s taken from my abdomen for Multiple Sclerosis, symptoms completely dissipated. 2. Two different treatments of PRP for plantar fasciitis over the course of 6 mo. My plantar fasciitis is completely gone. 3. 2015 bone marrow aspirate taken from my hip and amniotic tissue donated from live healthy births to treat my ACL injury (from a skiing accident) I am now 1 mo. post-op and am walking, hiking, and biking! As a patient I do my own research and have had amazing experiences using my own cells to avoid painful surgery, months of recovery and lots of pain and suffering. While you all discuss whether this clinic or that clinic is “safe” for patients, this patient is going to jump on her bike for a little morning ride in the mountains of Colorado! I will ALWAYS choose my own cells over anything else the medical community has to offer!
@Jennifer, Thanks for sharing your story. Where did you receive the amniotic stem cells (which are of course not your own)? My sense is that amniotic cells are definitely a drug product. I haven’t seen much debate on that. Paul
Thank you for your statement. I agree with you and I think government should control these clinics.
It think it is disappointing that Dr. Adonis Maiquez don’t answer these questions with arguments, after he has written such a statement above. Dr. Maiquez, why don’t you discuss with us your point of view with arguments?
I think these discussions and statements are really very important to inform potential stem cell patients and to help them to make a decision.
I hope government is going to oblige stem cell clinics to publish their data.
Furthermore I hope stem cells will change our medicine and will have a great future.
Many thanks to you Paul for your intersting blog, which helps us to get to know more about the actual stem cell developments.
Bianca
@Dr. Maiquez, I would appreciate a answer of you and I really would like to read your arguments. I think you mean stem cell applications are safe and effective (your comment above). Why do you have this opinion? Are there any other arguments? Please explain this to us and the potential stem cell patients.
Thank you in advance.
@Bianca, you make good points.
When it comes to oversight of medical products and procedures, the government (e.g. the FDA) is not perfect and I’ve advocated for FDA reforms on stem cells. But what’s the alternative to at least some government oversight? In the US and in other countries, industry self-regulation hasn’t worked well whether it is energy, cars, financial companies, etc.
It makes me concerned that so many stem cell clinics do not seem to be receiving visits/guidance from the FDA or guidance from state medical boards. It isn’t clear why the FDA has been so passive of late in this area, but that could change. You might find my posts on the new draft guidances from the FDA (that for example cite SVF as an example of a biological drug). You can search on the blog for “draft guidances” to find those posts. Paul
Hi Bianca,
You ask a lot of great questions.
Mostly there aren’t great answers though.
This area we are discussing is full of unknowns.
I believe in a general sense that many of the clinics are selling stem cell hope based on very little data.
The burden should be on the clinics and the doctors there to demonstrate before they start selling these stem cell drug therapies that they are safe and effective. I think they owe that to the patients and that’s been the tradition in America for new drugs.
Historically, you don’t just go ahead and try thousands of experiments on people (and charging those people) until or if someone else proves that some of them are unsafe and then stop those. Would that make sense? A lot of people would get hurt or waste their money.
The way it is now in my view in the stem cell clinic world generally is that patients are paying many thousands of dollars to be guinea pigs, being part of a for-profit experiment.
Again, I hope that the clinics collect data and publish it in a timely manner as that will definitely help clear things up.
Paul
The discussion seems to be a discussion about a stranger.
Because we say if there is published data, it could ….
if there is no published data, it could not …
But the interesting point is Are there data, which support the one or the other side? Is there any evidence for the safety and the helpfulness of these kind of therapies?
Or is there any evidence for the opposite?
Or is there no evidence for nothing? And the only reason to do such a therapy is the hope, that stem cells may coulp help – but in fact nobody knows?
There are so many experts writing in this forum, but why nobody answers these questions (and my questions above)?
I think you want to help the public and inform about stem cell clinics, but if you want to do so, why don’t you answer these questions? You could only help us, if you inform us with facts.
Please help us to understand more about stem cell clinics and the use of stem cells to heal people.
Thank you in advance
@Adonis Maiquez
@Professor Knoepfler
You have a complete different view, please answer these question to us for just one time.
It is sad that certain obsessions that consume all our actions and thoughts to the point of just suspending reality. Paul in your mind, the FDA regulation that categorizes stem cells as a drug is fully acceptable and justifiable. Your lack of experience in the medical practice field is shadowed by your academic perception of research protocols. Remember, as the FDA decided to deem our own stem cells as a drug, it entered a new realm of supervision for medical doctors. A field that always been historically supervised by State Boards and civil courts, and one of these has stepped aside when the FDA decided to regulate stem cells as a drug. There are approximately 970,000 medical doctors in the U.S. This is an issue when you compare that number with those of pharmaceutical companies, biotechs, and research universities. FDA cannot supervise that sheer number which sets a vacuum for doctors to do whatever they want. They need to step aside and let the state boards handle it, like they always have in the past and present. They have done a great job and with more venturesome medical procedures. Remember, we are not talking about the potential mass distribution of prescription drugs.
@Adonis Maiquez, M.D.
You seem to have insider information about similar stem cell applications.
Could you please help us and give us the information, we are looking for?
Which stem cell therapies are useful and could help people? And what are the success rates of these therapies?
I am also interested in the mechanism of these therapies. For example, if someones joint is treated.
I imagine they take some fat from me with a syringe. After this they isolate the stem cell from the other cells. After this they may multiply these stem cells in an incubator. And after all they inject theses cell in the joint and hope that these cell will turn into cartilage cells and get stuck to the cartilage of the joint. On this way it could possible to heal the cartilage.
Is this idea of the process of a stem cell application right?
Please consider here are not only stem cell researchers reading this blog and so it would be a big help to explain this background to make it more understandable to the public and the possible patients of a stem cell clinic.
And just to come back to my example of the cartilage. Is there any evidence that stem cell applications can heal cartilage and how big is the success rate?
If you have background information about possible success rates of other applications, I am also interested in these.
@Adonis Maiquez, M.D.
@Professor Knoepfler
Please help us – the possible stem cell clinic patients – and answer us these questions.
Very true Paul, which one do you put more adherence to the doctors, patients, or the researchers like yourself? If you pick yourself, then what’s the point?
I think the most interesting question is: Has this clinic or this doctor published his data about his treatments and his success rate or not?
If there is no published data, why denies this clinic to publish them?
I think everybody can make up his own mind, in my opinion:
no published data means I won’t believe in the reliability of the medical applications, and I think most people will think the same,
so the key question is:
Are there data: Yes or NO ? …
I think a better way would be 1) to have a law that says the patient pays on a sliding scale with an effective treatment getting the facility full payment, The stromal vascular fraction may have mesenchymal stromal cells whose numbers depend on how the cells were processed, so 2}treating doctors need to document the number and type of cells, excepients or incipients in what they have injected just as they would do if they had to remove blood from the patient and give it back at a later date, The safety should also cover endotoxin testing and facility cleanliness. Blocking the SVF treatments by calling them out for non homologous use could also negate a lot of legitimate FDA approved studies where bone marrow/ mesenchymal stromal cells are being used. These phase I trials do treat diseases not related to bone or blood and all these studies in “phase I” need to show are that the cells are not detrimental to the patient.
Simple Paul: It is safe (you should show the data when you say it is not) and it works (ask the thousands of patients around the globe that has helped). As for “crooks”, YES, put them down. But don’t assume every physician or every clinic opening is. I would be careful discrediting them, since they are so close to you, you might end up needing their services! A better approach would be “this new clinic opened, I hope they can help patients and hot harm them. the data is confusing but as long as they not harming people the few they will help is worth it. As for the poor who can not afford it, hopefully the more SC they do the faster is approved or not”. By the way CABG has 3% mortality rate, 25% morbility, 40% failure rate and 25% worse social interaction after procedure, so go figure what “FDA approval”mean.
Let’s see if I understand this correctly, you are a university professor, PhD, who has NEVER treated a single patient.
The doctor – has over 40 years of experience treating patients – and has treated likely thousands upon thousands of patients.
Just think you should keep things in their proper perspective
@Ray,
There’s room for healthy dialogue between different stake holders in the stem cell world no matter their degrees, backgrounds, etc.
Yes, that is true, the should publish all their data. The goverment should oblige them to do this. I think every serious stem cell clinic will publish their data voluntary.
If a clinic denies to publish, I won ‘t believe in their treatment
Although I don’t know you – or the doctor – I don’t understand what you are trying to do Paul.
Did you call the doctor – like professional to professional – and speak with him?
Wouldn’t that be a professional way of exploring this further – rather than “blogging” ??
If you were serious about your comments, it seems to me, you would have taken more of an adult approach.
Blogging is one-sided and naturally biased.
Is that what you are trying to do?
Well, if you go visit – you should be professional and call ahead to make an appointment.
Why are you so sure that this method is not working?
@Bianca, I’m not sure, just skeptical. I’d like to see all these clinics publish their data.
As far as I can see, the core issue with the treatments given by these clinics is not their rationale or their claims or even their marketing methods, but the fact that the treatment should be classified by law as a drug, as Paul has described in several posts.
This can only be solved by the FDA (and other national drug administrators) passing clear and binding regulations, which make clinical trials unavoidable. At least this way both sides will be clear about what the therapy can achieve and what it cannot.
But my fear is that it will be left to incubate like a field trial until someone suffers or dies before the FDA make a move.
Hi Paul, The stromal vascular fraction isn’t just about fat. It is also about vascularization of other tissues:
http://www.nature.com/srep/2013/130705/srep02141/full/srep02141.html
So this is something that might turn out to be a part of useful treatments for many diseases… in many tissues throughout the body.
That brings us to homologous. I wonder to what extent SVF are simply tied to fat, perhaps they also play a broader role in the body?
In defence of the FDA, they may have been busy with other pressing matters. They have just issued a warning about NSAIDs;
http://www.fda.gov/Drugs/DrugSafety/ucm451800.htm
OK, those who pay attention to the literature may see the warning as a long time coming… but, patience.
If we are to protect patients from phoney treatments, then we need to get the details correct.
Does the doctor have appropriate expertise about the disease being treated? It seems unlikely that one doctor could specialize in all of the diseases that you list.
Is there any scientifically rational basis for the specific treatment of the specific disease? I guess we’re speculating because we don’t have the details.
Does the clinic clearly explain its treatments and identify appropriate literature to back them up? That is the question I’d like you to ask when you visit. If they are evasive, well that says a lot. If they give the details then you and your scientific/medical colleagues can make a professional evaluation… Perhaps the clinic might even see some benefit in such expert analysis? I’d help, but I have no credibility in your field. All I can do is ask questions and point to studies done by other people who might know a thing or two.
Interesting that you claim that MS have nothing to do with fat… Wikipedia suggest otherwise: “Cholesterol is an essential constituent of myelin.[2] Myelin is about 40% water; the dry mass is about 70–85% lipids” – https://en.wikipedia.org/wiki/Myelin
and: “Lipids are a group of naturally occurring molecules that include fats” – https://en.wikipedia.org/wiki/Lipid
Also quite interesting that you obviously believe SVF in a drug – do you ever hear yourself??
Best rgds
Bjørn Westby
Hi Bjørn,
Thanks for the comment.
To be clear, there is a difference between fat (a tissue) and fats (molecules). Abdominal fat is made up of adipocytes or “fat cells” and a tiny bit of some diverse types of cells, the latter of which make up SVF.
The myelin sheath has some lipid molecules in it indeed, but the actual adipocytes or the other cells normally found in actual fat tissues are not to my knowledge present in the myelin sheath.
As to whether SVF is a drug, that is my opinion based on reading the FDA individual guidances given to specific cilnics(s) and the recently released FDA draft guidances that specifically say that SVF is more than minimally manipulated. Clearly CSN disagrees.
Paul
Hi Paul-
They will let you in, give you a tour, and take a picture of you with the head of the clinic. Then they will post it on their website, without saying that you endorse them, but the implication will be there. No photos, and be careful what you say!
Jeanne
Thanks, Jeanne…gotta think this one over.