In this post I propose that researchers and patients advocate together to pressure the stem cell clinic industry to collect and publish such data.
Why do I make such a proposal?
Many thousands of patients have bought stem cell interventions from non-compliant stem cell clinics. Thousands of others are considering doing so. You can see a map at right of all the stem cell clinics advertising in the US as of 2016.
Many in both groups contact me on a regular basis.
These patients are looking for hope and information. Quite a few feel that even today’s “modern” medicine has little left to offer them.
Sometimes patients in that kind of situation have expressed frustration to me over my advocacy for a relatively high degree (“high” in their opinion, “appropriate level” in mine) of regulatory oversight over stem cell treatments here in the US.
I don’t claim to speak for them by any means, but my sense is that they feel that such regulatory oversight interferes with their ability to freely get stem cell interventions that at least have a chance from their view of being helpful whereas other forms of medicine have not worked for them.
Some are frustrated or even angry, often times with me. Many others are quite appreciative that I take the time out of my crazy schedule to interact with them and tell them my perspective.
More broadly, how can we work together even more often instead of butting heads?
One area of common ground between patients and stem cell researchers such as myself is in the area of stem cell clinic publishing.
Stem cell clinics see a lot of patients and as such could be collecting a large amount of data on how patients who have received transplants of stem cells are doing.
They should absolutely also be publishing that data and putting it into Clinicaltrials.gov if possible.
I propose that researchers and patients advocate together as a team to exert pressure on clinics to collect and publish such data.
There is absolutely no legitimate reason for such clinics to be not publishing their data. Yet, they almost never do it. That is wrong.
It seems to me that this is one area that patients and academics can agree on.
The benefits of clinics publishing their data on stem cell patients are numerous including in essence validating the patients’ experiences as real and meaningful, getting valuable information out there on the treatments themselves that could be helpful to the clinical field more generally, and advancing the biomedical science.
Publishing would also give more credibility to the clinic and make it more legit.
Clinics are nonetheless choosing not to do this almost 100% of the time.
If even some of the treatments are safe and actually do work as so many people are claiming, publishing data on them will help everyone.
When I talked to Arnold Caplan earlier this year (see all 4 fascinating parts here), he told me that one of his great frustrations is that the stem cell clinics just do not publish their data. He said that needs to change.
Let’s work together to change the clinic leaders’ minds by pressuring them to publish.
What could possibly be the downside to this for patients and the field?
I don’t see one. It’s a win-win idea.
Readers on this topic might also be interested in the following post on the FDA Law Blog
http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2013/06/striding-towards-greater-access-of-clinical-trials-data-and-results.html
Hear hear! The International Cellular Medicine Society seems to have similarly worthy goals.
Patients can also contribute by being discerning clients.
With stem cell medicine at such an early stage, I was only prepared to do business with scientific-type doctors who had already published results and were doing work that was consistent with that fraction of the peer reviewed literature that I could access. That way, even if things didn’t work out for me, at least I’d have the comfort of contributing a data point that might help someone else at some future time.
This talk presents a problem that is very related with this topic. As being the promotors the ones conducting the trials, how can one be sure that the results were indeed so positive? Should not all data be clearly available, in an impartial place? Stem cells are not perceived as multiple treatments, as nowadays drugs. Therefore, a disaster will affect all stem cell therapies. In opposition, researchers, companies and patients as starving for new positive evidences. Would not this bias lead to a bias in how the clinical trials results are published? Now we mainly need to understand what works, and what does not work… what is safe, and what is not safe. Putting a so new science being pushed to the market may lead to risks so great that can indeed stop it for long years, in the rush of creating a new era.
https://www.youtube.com/watch?v=5vTSSxcNK4s&list=WLNmt2olb3Fh6yB1VOrxJT4NJDcG9EYD8A
I’m not entirely sure non-standard protocols would be accepted for publication by any respectable journal without adequate IRB sign-off. And as we’ve seen, more than one company in the business of providing “clinical treatment” (sans formally registered trials) have a loose (at best) definition of adequate IRB oversight.
Good point, but there are journals that are more relaxed about this issue plus the possibility of “publishing” data online via databases to make the information available to patients, physicians, and scientists.
It’s a nice suggestion but confuses clinical trials with clinical treatments. The problem is that most doctors don’t have the follow up resources that are inherent in a clinical trial. If a patient goes to Panama for a treatment and then goes home how does one gather the data? How do you follow patients who have dispersed to other countries in multiple locations? I’m not advocating for these stem cell clinics, just saying that the argument is a straw man for not allowing them and insisting on conventional clinical trials.
Paul:
This is Dr. Rodriguez, from ICMS. Plenty people, from ISSCR, ISCT, even our organization- ICMS realize the need for a Registry.
At this point, advocating is not what is needed. People have been advocating for years and everybody then keeps on waiting for “someone in a position of authority” to get it done.
What is needed now is for people to do it.
Chris Centeno has done it.
We at ICMS are trying to do it but it has not been easy, our first tries did not work well, and getting a solid accountable Stem Cell Registry that is self sustaining is not easy. If it was, many would have done it.
The ICMS is working with limited resources, but we are in the nitty gritty of looking at the details of what did not work, what we need in our database, and trying to convince people to do some of the work pro bono. Not easy.
What other interested parties have to decide today is how much work they personally are willing to do to make this work, and who they are going to donate their work or money to make this happen.
Advocacy is a laudable goal, but at this point the tedious task of actually formulating a database and deploying it is what will get it done. We are trying, and it’s not easy.
The computer age has completely changed all this for people looking to make decisions on where and if to have an SC treatment.There are many online patient groups that I’ve found devoted to information about specific clinics & doctors. Everything is talked about in these groups; improvements, no improvements, side effects, cost, hotels stayed in, clinic cleanliness, staff professionalism etc. Many patients have videos filmed while they are having their procedures to share with online group members. By the time a patient actually gets to the clinic nothing about the doctors, the facility, or the procedure is unfamiliar. Most of us have spent quite a bit of time on the phone talking our doctor directly. It’s much more information than just going onto a clinics website or reading a report written by a clinic. I think some clinics might try to hide the bad things that happen. The patient community tells it like it is to other patients! I know people who haven’t had any improvement with stem cells. We all know that. I trust what a patient would tell me way over what a doctor or a clinic would & the clinic in Panama has a very high success rate for treating multiple sclerosis patients. Also the care and professionalism in Panama far exceeds anything I’ve have ever received with my doctors at home. Talk about personalized care! That’s why so many of us go there and are repeat customers. Published data would have just been another thing I would have considered, but other peoples experience is what I made my final decision based on. I hope my input helps you understand a bit more about what goes into considering an overseas SC treatment. It’s not a decision any person makes lightly.
Thank you for the comment, Anna Marie. I appreciate your constructive, logical tone.
I have heard that the quality of medical care in Panama is generally excellent.
As much as patients educating patients can be helpful as you said, I believe there is also something to be said for actual published data as being helpful too in another way.
Wouldn’t it make a difference to paying patients if stem cell clinics published their data – at least on their own web sites? For example, if Dr Lopez published how many patients he’s treated so far for each indication, how many have shown improved symptoms and how many haven’t, wouldn’t that help patients make a better informed choice about seeking treatment? I would think a liver failure patient would like to know if he’s treated 3 patients or 120. They’d probably also like to know what percentage improved and what percentage have not. they’d probably also like to know what, if any, the adverse side effects are. None of this has anything to do with the US FDA. Certainly this data is readily available in Dr. Lopez’s case since he’s doing clinical trials and obviously has been collecting data on all his trial participants, yes?
It seems to me that the published data, whether in a journal or on the clinic’s website (the former is much more convincing of course) would do nothing but help patients.
We spent 7 months asking for your assistance/suggestions in bridging some gaps with patients. I personally provided you with very detailed information on my quest to regain my health. As you know, I am a very active patient advocate. I guess that leaves me perplexed as to your true intentions in this “plea to the patients.” As NO Option Patients we’ve tried desperately to keep a healthy line of communication with the scientific community. Actions towards our efforts contradicts this new plea for patient involvement. We’ve always been clear it’s ok to agree to disagree. Without a healthy line of communication we can never work towards realizing change. I agree with the other patients who have commented, as I’m sure you would expect. Would the FDA really listen to overseas clinics publishing their data? If so, then let’s go for it! The primary patient objective in participating with your “plea for help,” totally revolves around the idea that we could motivate the FDA in some way to hasten clinical trials, so sick and dying patients could have access to their own cells, in a last ditch effort to regain quality of life. It would be most helpful if you could outline you ideas, including the patient participation, for a full court press, for overseas clinics to publish their data. Please include your motives/hope for what you would like to accomplished if this would ever come to fruition. Disclaimer… remember, we have no pay check coming from these efforts, nor or we affiliated with any overseas clinics with free treatments, as some have suggested we might…..
http://www.stemcellpioneers.com/showthread.php?t=6862 This is an interesting article explaining the frustrations of doctors with the current FDA clinical trial system. Even with extensive European use and acceptance of these cardiac devices, the FDA is still requiring long, expensive clinical trials, costing many their lives or forcing them to seek treatment offshore. This sounds like the predicament many of us who want to be able to use our own stem cells have. Is the US becoming a third world country when it comes to access to availability of cutting-edge heart devices and other medical technology? I’m not sure how pressuring stem cell clinics to collect and publish data will make a dramatic difference after reading this article. I think there needs to be a significant overhaul at the FDA in order for any progress to be made.
More openness is always better including actual data.
Dr. Lopez, are you actually claiming that you are running simultaneous clinical trials for Acute MI,Sub-acute MI, Congestive heart failure, Post-infarct Congestive heart failure, Critical Limb Ischemia (IM for localized ischemia, direct for surgical, non-surgical and Intermitent claudication), Emphysema, Chronic Bronchitis, Pulmonary Fibrosis, Retinitis Pigmentosa, Macular Degeneration, Diabetic Retinopathy, Glaucoma, Liver failure, Type II Diabetes, Erectile Dysfunction, Frailty Syndrome, Renal Failure,Leukemia, Hodgkin’s Lymphoma, Multiple Myeloma,Systemic Lupus Erythematosus, Rheumatoid Arthritis, Multiple Sclerosis, Parkinson’s Disease, Alzheimer’s Disease, Stroke, Diffuse Lesions, Cerebral Palsy, Autism, Osteoarthritis, Hip, Shoulder and Knee Degeneration and Post mastectomy breast reconstruction? That’s almost three dozen! http://www.regenerativemedicine.mx/index.php Apparently these trials have been going on for 3 years according to this recent press release: http://www.virtual-strategy.com/2013/05/27/regenerative-medicine-institute-mexico-reaches-three-year-milestone And yet I found a paltry 13 “case studies” here: http://www.regenerativemedicine.mx/patient-stories.html and no published results. Perhaps you could tell us how many patients you’ve treated for each of these indications thus far and for each indication, how many showed any kind of lasting improvement related to their *disease related symptoms* (>1 year) and how many didn’t. “Improved quality of life” doesn’t count! Have any of the eye patients treated at your facility with adipose stem cells or their post-treatment US attending physicians ever reported severe adverse side effects that threatened their vision? As far back as 2009 your web site claimed to treat: ALS, autism, COPD, Crohn’s disease, lupus, rheumatoid arthritis, spinal cord injuries, eye diseases, cardiac disease, MS, Parkinson’s and stroke. Your home page claimed “Stem Cell Therapy is available now” and “We Offer state of the art facilities in neighboring Tijuana (Mexico) for effective stem cell treatment.” Note the use of the word “effective”. http://web.archive.org/web/20091214051204/http://www.regenerativemedicine.mx/index.php Any comment?
We in fact have IRB approved protocols in place as listed on our website, some of them are more mature than others as they did not all start at the same time, others are still in the pt. recruitment stage. As I have stated before we have published and have presented preliminary data as early as 09/2010 our safety paper as well as CHF and COPD will be soon be out for peer review.
Dr. Lopez,
Perhaps it will be easier for you to directly address my questions if I number them? I think it would be useful for all of us if you referenced each number in your answers so we can keep track of which questions your are answering and which questions you are avoiding. – Thanks.
1) Can you please list the clinicaltrials.gov identifier numbers for each of your trials so we can all look at primary outcome measures, secondary outcome measures, inclusion/exclusion criteria, sponsors, collaborators, etc?
2) Can you please give us the names, degrees and affiliations of the IRB members who approved your protocols?
3) Can you please give us a link to the 2010 preliminary data you’ve mentioned?
4) Can you tell us what percentage of “patient funding” goes directly toward your “clinical trials” and what percentage goes to profit?
5) For each clinical trial so far, how many patients have you treated, and what is the estimated enrollment number for each? Of course if you answered #1, then disregard.
6) Can you give us any idea, in broad terms (improved symptoms vs not improved or worse) how many patients have shown improvement after 1 year for each indication?
7) Have any of the eye patients treated at your facility with adipose stem cells or their post-treatment US attending physicians ever reported severe adverse side effects that threatened their vision?
8) Why did your web site claim the following in 2009 regarding efficacy for many diverse indications such as ALS, autism, COPD, Crohn’s disease, lupus, rheumatoid arthritis, spinal cord injuries, eye diseases, cardiac disease, MS, Parkinson’s and stroke? “Stem Cell Therapy is available now” and “We Offer state of the art facilities in neighboring Tijuana (Mexico) for *EFFECTIVE stem cell treatment.” (*emphasis added) http://web.archive.org/web/20091214051204/http://www.regenerativemedicine.mx/index.php
Paul, I also applaud this effort. We have collected our data at great cost (we spend about 300K a year currently) and have published our data (we still can claim the world’s largest stem cell safety paper at http://www.ncbi.nlm.nih.gov/pubmed/22023622). We are preparing for a deeper dive into the approx >1,000 orthopedic stem cell patients in our registry that are actively tracked with CRO quality software and will begin readying that for publication this summer, including an up to 5-8 year follow-up on patients treated in 2005-2008. We also have three RCTs that we are recruiting for right now listed here:
http://clinicaltrials.gov/ct2/show/NCT01850771?term=NCT01850771&rank=1
http://clinicaltrials.gov/ct2/show/NCT01788683?term=NCT01788683&rank=1
http://clinicaltrials.gov/ct2/show/NCT01850758?term=NCT01850758&rank=1
Thanks for the comment and info, Chris. Your efforts at collecting and publishing this data sound like they could be very helpful to the field and patients.
Registering all trials and reporting the data is important. It is a start. If you look at clinicaltrials.Gov some have started to do this.
I could not agree with you more Dr. Knoepfler, Regenerative Medicine Institue, Mexico will keep publishing it’s results as soon as particular trials mature, this is the case of our CHF and COPD trials. RMI has enrolled a total of 119 patients since the program started back in 2010. We are presently working on a safety paper and should be ready for publishing soon, as I indicated in another blog earlier this month. Case report studies have been available as early as 09/2010.