There is real hope for treating spinal cord injury with stem cell-based therapies in the future. However, unfortunately regulators in Japan have taken a major misstep in approving a not-ready-for-primetime mesenchymal stem cell (MSC)-based approach to spinal cord injury. Their decision is dangerous and unwise.
In a Nature piece (linked to above) by David Cyranoski we learn that the MSC therapy in question is still unproven. There are only limited data available to support it, which are not from rigorous studies. The claimed outcomes so far using this therapy are also puzzling and controversial. Thus, the approval is extremely high risk. I believe it is likely to do more harm than good to patients and the stem cell field.
Regulators gush
Some Japanese regulators are more than upbeat on this approach:
“This is an unprecedented revolution of science and medicine, which will open a new era of healthcare,” says oncologist Masanori Fukushima, head of the Translational Research Informatics Center, a Japanese government organization in Kobe that has been giving advice and support to the project for more than a decade.”
A phrase like “unprecedented revolution” is often a red flag for hype.
Many scientists are very concerned, while inventor is upbeat
Ten independent experts that Nature contacted were concerned about the approval:
“But independent researchers warn that the approval is premature. Ten specialists in stem-cell science or spinal-cord injuries, who were approached for comment by Nature and were not involved in the work or its commercialization, say that evidence that the treatment works is insufficient. Many of them say that the approval for the therapy, which is injected intravenously, was based on a small, poorly designed clinical trial.”
This doesn’t sound good. The approval seems like a recipe for trouble and sets a bad precedent. Of course, the inventors of this product now called Stemirac are very positive:
“One of the inventors of the treatment, neurosurgeon Osamu Honmou of Sapporo Medical University in Japan, says he is preparing to publish a scientific paper that will discuss the clinical-trial and safety issues. “I think it is very safe.” He says he did not do a double-blinded study because Japan’s regulations do not require it. “The most important point is that the efficacy is dramatic and definitive,” says Fukushima.
The unpublished results describe a trial of 13 people, who had experienced spinal-cord injuries in the past 40 days. The team found that infusions of stem cells extracted from the patients’ bone marrow helped them to regain some lost sensation and movement.”
You can see Dr. Honmou’s PubMed record here with many papers on MSCs including in rat models of CNS injury.
Concerns about the science and logic here
To me it doesn’t make a lot of sense that an IV infusion of MSCs would significantly aid spinal cord injury. For one thing these cells tend to accumulate in the lungs. They also mostly don’t survive more than a few days. How would this help an injury as severe as major spinal cord damage? There is also some claim that the MSCs turn into brain cells such as neurons, which is highly controversial.
I wonder if they ruled out cell fusion? In work by my lab in collaboration with my UC Davis colleague Veronica Martinez-Cerdeno where we transplanted undifferentiated hESC and hIPSC into mouse brain, we found a surprisingly high degree of fusion of the stem cells with resident brain cells including neurons.
Unfortunately, it seems likely that placebo effect played some major role in the study results related to this approval. Once patients start paying for it (which kicks in soon), the placebo effect is likely to be further amplified.
It also isn’t right for patients to have to pay for an unproven therapy.
Update: I asked Doug Sipp, who is an expert on the Japanese regeneration medicine framework, and he highlighted three areas of concern:
“Three of the things that should be raising eyebrows are 1) why no controls, randomization, blinding for study that just involves IV infusion in a non-fatal condition; 2) why such a small study size for a condition that is not particularly rare; 3) why was the study not published prior to conditional approval? “
Big potential negative consequences
Sadly, this controversial approval by regulators in Japan may end up having another negative consequence. It’s likely to be a big help to unproven stem cell clinics. Some of these for-profit clinics sell various kind of MSCs for spinal cord injury, autism, or other conditions that don’t make sense at this time.
More broadly, the relatively permissive regenerative medicine regulatory system in Japan has been controversial. I discussed it and also the RMAT system in the US in my recent piece in Cell Stem Cell, “Too Much Carrot and Not Enough Stick in New Stem Cell Oversight Trends.”
This new approval is by far the most controversial to date and is a step backward for regenerative medicine science.
I received autologous stem cells derived from adipose via IV to treat my autoimmune disease. By week 6 my joint and bone pain was completely gone. I did 2 of these treatments 12 weeks apart, as recommended. This was 7 months ago and today I am symptom free. I also used these same cells via intrathecally to treat my 30+ years of spinal cord injury, C5-6 incomplete quadriplegia. I regained additional sensory and diaphragm. For example, I can now feel the soft fibers on my bath towels whereas before I couldn’t tell the difference between a hand and a towel. My coughing and sneezing strength has greatly improved. I no longer worry about choking either. My bladder also holds more urine and I have way more time to get to the bathroom to cath. My quality of life has improved dramatically! Now, the federal government has made this treatment illegal thus preventing me from additional treatments. These cells came from my body–they are not a drug! How come the pharmaceutical companies get to market drugs that knowingly cause cancer and death? How come they have the FDA’s blessing? For anyone who thinks the FDA cares about you, you are living in la la land. Keep moving the ball forward, Japan, and don’t listen to the naysayers.
You´re so right. I have taken stem cells every day for the last 20 years and I´m in the best of health. Apart from a little arthritis and diabetes, I have avoided Parkinson´s, Alzheimer´s and heart disease thanks to my stem cells. I grow most of them myself in a small allotment, but it is really the rhubarb that takes the glory as they have such big stems. I don´t see how the FDA can stop me being a vegetarian and it is shameful that they think they can call these products drugs – they came from my own garden, so hands off FDA!
The concern being raised on the Spinal cord injury, trials in Japan, using stem cell. Can you please confirm that the Japanese did not do any test at all on mice!!. If they did do trial on mice, then I would like to hve some more info on waht specific area the concerns are raised on?
thanks
Rehman
Inga,
Dr. Deepak Chopra and Dr. Joe Dispenza have a lot to say about the powerful effects of beliefs in our own ability to heal ourselves. You may love Dr. Chopra’s word, “NoCebo” effect from Ageless Body Timeless Mind. Plus, Dr. Dispenza’s book Becoming Supernatural: How Common People Are Doing The Uncommon recognizes the power of influence our thoughts have on matter with the blending of science and spirituality as being the same quest. Perhaps great thinkers understand this. Dr. Bruce Lipton created “ The Biology of Belief,” as well.
Unfortunately, such self aware tools usually fall into personal development and not so much into spinal cord recovery at an alchemical or medical level.
I have used these tools my whole life to overcome overwhelming obstacles personally and physically and I still have not a clue as to how to correct my skeletal structural deformities that caused my spine to collapse; one leg is 2 inches shorter than the other, a sacroiliac/ pelvic deformity where one side is smaller and now twisted, severe scoliosis with 12 discs impending my spinal cord, cord stenosis and more, as my “go- to” now is what will repair the damage caused by what limited movement that I do have such as annular tears from trying to be upright.
Ortho-Bionomy is a path to self care and a woman named Luann Overmeyer wrote the book. We work on resequencing movement from a horizontal position, however anything involving gravity and functional movement seems to elude my best intentions, imagination, visualizations, though I have been able to reverse paralysis on one side in the last 4 years.
Since I have not yet received living stem cells, I am looking forward to trying my own bone marrow aspirate soon!
Open to any suggestions!
“Unfortunately, it seems likely that placebo effect played some major role in the study results related to this approval.”
I think what we need to be doing more studies on is how to harness the incredible potential power of the “placebo” effect, which would include coming up with a better word for it! (I’m completely serious about this and the comment is not meant to be snide, which can be extremely difficult to parse in online writing, to say the least.) Paul, how do you think it might have been possible for a “placebo” effect to produce such a powerful result?
I don´t doubt that it´s possible you were scammed and I understand that you want to fight those who have caused you pain, but this is exactly why I would check out the procedure, the clinic involved, the likelihood of success, why my insurance won´t cover the treatment and a whole slew of other questions, especially getting the experience of different patients, before making the rational decision to pay for the therapy out of my own pocket,
You say you prefer anecdotal single patient histories rather than impersonal data informed opinion – but isn´t that why you´re in the position you are now?
Diane,
Both the DC and the MD that sold/ injected us with their product gave us their own “ clinical” success information, as well as videos and all kinds of “stem cell” information and they told us that their product was full of living stem cells.
We did not know that these purported “ stem cell therapy” products did not contain any living stem cells by their 361 FDA Registered designation at the time or we never would have made the purchase. We also did not know at that time that this product was never intended to be used therapeutically in humans per an Advisor for the company until recently.
It is astonishing that HCTPs can call themselves “stem cell therapy” at all since the FDA Registration states that they do not contain living stem cells and yet this 361 Registered HCTP “ stem cell therapy “ throws itself into the same arena as if it were the same as bone marrow aspirate, adipose or PRP.
It is easy to see now, how these doctors that sell these purported “ stem cell therapies “ by referring their patients to actual living stem cell information
( Bait)and then cleverly ( Switch) insert their dead birth tissue product as if it is the same a bone marrow aspirate, but less painful.
Some of my most effective therapy is not covered by insurance and some really effective, results oriented doctors just do not take any type of insurance.
I actually said that I prefer an outstanding expert with many years of direct experience in whatever help I may be seeking. Dr. Centeno’s work is a great example.
I have learned that a lot of purported “ patient reviews/ histories “ can often be fabricated to support the selling of a product.
We are in this position because we believed what these doctors said and did not expect that they were deliberately deceiving us for a profit and did not know that doctors would use a bait and switch technique to sell a 361HCTP as if it were a 351 Approved Drug.
Does your independent research make note of the difference between 361 HCTPs “ stem cell therapies” vs actual living stem cells 351 Approved Drugs?
@Avoidthe,
Note that 361s also can contain living stem cells, but they just don’t require premarket drug approval the way 351s do. For instance, minimally manipulated bone marrow stem cells used in a homologous fashion are 361s. Paul
Paul,
I appreciate the distinction and I do understand that 361s can include what is taken in its living state from one’s own body and put back into one’s own body, specifically, bone marrow and adipose, as well as PRP. It makes sense that there would be no drug approval necessary since it is not being distributed to anyone else.
However, it seems that given some people suffered blindness from the misapplication of adipose in this example, that there does indeed, need to be clinical trials and written legal procedures for appropriate application.
The fact that both tissue banks and marketed “stem cell therapy” products also claim the exact same 361 FDA Registration is unacceptable ( and unscientific) in my opinion, especially after my family’s experience with a 361 Registered purported “stem cell therapy” product being sold by telling us that it contains living stem cells like fresh bone marrow aspirate, adipose or PRP , which triggers the need for a 351 FDA Approved Drug designation because it does involve metabolic activity and it does come from another donor that is not a relative, per the FDA’s own stated distinctions.
In addition, what can be contained in these allograft products marketed as “ stem cell therapy” makes the “ homologous use only” distinction null and void for any application since what is in them is not going to magically morph into anything other than possibly infection.
These allograft products can contain birth tissue and more, from any living mammal, not just human.
As if these undifferentiated HCTP statements were not enough, the fact that any 361 HCTP can be
“ cleaned” by irradiation ( though there is no specific universally accepted procedure that
“ cleans” this tissue according to the MMWR/ CDC Sept 2018 report stating that ) and then cryogenically preserved in hopes of magically imparting life at a later time on demand seems preposterous given what we do know about radiation and freezing and their effects of living cells.
Within this “ 361 HCTP soup”, distinct designations based on How these 361 tissues are “Sourced” and then “ treated” ( as in tissue from tissue banks and marketed 361 HCTP products that are irradiated and cryogenically preserved) desperately need to be made in order to progress general medical, scientific and potential patient conversations.
A good start might be a separate and easily distinguishable designation for those cells sourced from oneself and reinjected immediately back in to the source itself. Even a simple “371” at this point.
Then, perhaps, the marketed 361 Registered HCTP products actually having to legally market themselves as just that, not some misleading “ stem cell therapy” product to be easily confused for the consumer and even more easily manipulated by unethical doctors and marketers, such as 361 vs 351 ( or “371” for that matter) or Registered vs Approved or throwing this dead, irradiated birth tissue from any living mammal of any sort, or otherwise, into an indistinguishable mix that is a fertile breeding environment for predatory, pathogenic profiteering.
Tissue banks can de differentiated as well with an easy numerical switch, perhaps “391,” or at the very minimum, create a distinction between a Registered Tissue Bank that stores organs for transplantation vs tissue banks that store cord blood vs tissue banking for the manufacturing of unproven, untested 361 Registered only for the making of these HCTP products.
That considered, there really is no reason for all this complication, except that someone is profiting and maybe even more than we presently know, under that overly used go-to cliche.
It might be interesting to note just how much money tissue banks with the same 361 Registered designation as the falsely marketed HCTPs might be making from this “ recycling “ business with a never ending supply of marketable material.
Hi Diane,
Glad you visited avoidthestemcellscam.com and I am curious to know if you actually listened to any of the content in the short informational videos or articles that we posted by Dr. Centeno, Dr. Purita or ipscell.com because by your statements, your research or understanding appears very limited and it seems that you are still missing the boat on WHY we are doing what we are doing to help people avoidthestemcellscam.
Unlike any independent researchers, doctors, scientists, silver tongued salesmen skilled in neurolinguistic programming or marketing geniuses, we are people who are NOT getting paid to promote any agenda or profit from any of what we discovered. We simply aim to share our experience so that others who are also not in a position to discern between the fact that 361 FDA Registered HCTP’s do not, by their Registered designation, contain any living stem cells. Only per the FDA 351 Approved Drug designation( which is for blood to blood transfers only)do any drugs contain any living stem cells.
We also wanted to share our story because, according to our former attorneys,( we are Pro Se so that we may share this information as we see fit to help the most), who wanted a quick settlement, also stated that this is the first case of it’s kind where this black and white information is laid out so clearly. This is a case that needs a trial, not a settlement. There is no “ hope” or gray area here.
In addition, we did not intend to purchase a vial of hope, dead and irradiated birth tissue or a contaminated allograft that can contain tissue that is equine, bovine and more. We were told that we were purchasing “Living Stem Cells” from a live, healthy human birth. That is what we paid to receive and that is documented on our website where the doctors told us in writing that we were getting live stem cells.
Thanks to Dr. Centeno’s informational blog and videos, in particular one about about chiropractic offices selling purported “ stem cell therapies” that do not contain any living stem cells, we were able to understand both that we had been scammed and how it is being done as it was exactly what happened to our family. The fact that the 3 of us had received this “therapy” and NONE of us had ANY results after months and the fact that our eldest family member had become much worse, is what prompted my research so that I could understand why any of our “promised” results never happened. If we had been told the truth about these HCTPs as far as what is in them, we never would have made the purchase, nor would anyone else.
I do not see that your independent medical opinions on your website include clinical trials data or research on instances where patients were told that they were getting a drug ( living stem cells), but instead were given a HCTP. Of course, I haven’t yet read your response to Paul’s question. I do know there was another Dr. on here offering independent research and stem cell coaching. Once I understood that we had been deliberately deceived, I was able to conduct my own research via doctors and sites such as ipscell.
Your presence here sounds more like what you were projecting onto Dr. Centeno “also profiting from the business and cannot be said to provide a truly independent opinion” when the same can easily apply to your
“independent medical compass,” if there is really such a stationary Magnetic North in the first place for anyone. Offering an above board service for financial gain is irrelevant. Profit from unlawfully selling products that are not drugs as if they are drugs is unacceptable according to our Rule of Law and the FDA.
In my opinion, your statements about Dr. Centeno reflects more about the limited lens of your perspective. I personally learn more consistently about this industry from both Dr. Centeno and Paul Knoepfler than anywhere I have perused on the internet. There are other reputable doctors with the same opinions who are not as vocal and I know from our own personal family experience that this easy to assimilate approach and explanation by a reputable source like both Dr. Centeno and Paul, is what is needed to help people understand this game where 361HCTPs are even allowed to call themselves
“ stem cell therapy” as if the products are the same as bone marrow aspirate or adipose and that there are doctors who will unflinchingly lie about their products for a profit without any regard to the humans on the receiving end. For you to simply align with that speaks volumes.
What Doug mentions about Dr. Centeno is correct as far as I have researched. He is in compliance with the FDA and took his culturing of stem cells to the Grand Caymans. He even states that no one therapy works all the time for everyone. I prefer his history and direct application of what he has done for years to some impersonal data informed opinion. I offer what makes sense to me and what has assisted my family. I have never met him personally, as travel is difficult.
Diane,
If you would care to visit avoidthestemcellscam.com and read the links entitled, “Understanding the Sales Pitch” and “Our Story,” the links address,very specifically, the answers to your first question, which is why we created it in the first place, provided people actually bother to read it for themselves.
In short, there are a Lot of independent medical professionals who agree that actual living stem cells show promise for a variety of maladies, but that is not the issue here. What is really happening is that MDs and DCs (in our case-though there are more independent medical professional titles exploited in this arena) are actually feeding patients lies to sell their purported “stem cell therapy” product by telling them that their product contains Living Stem Cells, when by it’s FDA 361 Registration for HCTP’s, they cannot nor do they contain any living stem cells at all.
While we can all find endless information in support of the benefits of living stem cells, if medical professionals who have the privilege of titles attached to their names with designations such as MD, DC and more, those doctors should be held accountable for choosing to knowingly deceive their patients with “perceptive” marketing and sales skills that are outright lies in order to profit from compromised individuals to whom it is the cultural practice du jour to seek out the skills and knowledge of licensed medical professionals.
We sought out information about stem cells, however through a clever “bait and Switch” sales technique used by the DC and the MD where they talk about living stem cells and then switch to their product while talking about living stem cells and what they do in a developing fetus and they say that their product does the same thing. There is proof stated on our website through various reliable sources, including text messages between my family and the DC and MD who lied, plus, the original Advisor for the now FDA Recalled product used on our family and the people made sick, states that the product is not intended for therapeutic use in humans.
Comparing the selling of herbal tea to the selling of 361 FDA Registered HCTPs being sold like they are 351 FDA Approved Drugs is short sighted in my opinion, as the only correlation between the two is that they each have vastly distinct points of sale in order to reach the public. Needing the expertise of a doctor and depending on that guidance in order to get a Drug (aka “living stem cells” in our case) and being sold dead birth tissue that has been irradiated and cryopreserved as if it were a drug (actual living stem cells per the FDA 351 Approved designation) is unacceptable and must be addressed accordingly since many trusting people are being ripped off and potentially made sick by the very physicians we are supposed to be able to rely upon when our family members are ill.
Can you please help me understand what you mean by “making the government responsible?”
FYI, People have to first realize that they have been scammed and sometimes, as we know from boiler room scams on wall street and numerous others, white collar crimes can be more challenging for those who are not involved in that particular industry as in this stem cell scam going on through licensed medical professionals. Then, we must understand how this is happening and take appropriate action.
I agree with your unstated premise that we must all upgrade our own self reliance and accountability and let that also apply to those who are choosing to profit by illicit means that take advantage of the elderly, disabled and more.
Also key, I realized that we had been lied to about what we were getting in December 2017( we were injected in June, July and August between 3 family members). We are Pro Se in a civil case at the moment that was filed in January 2018 and is ongoing and public as a lot more evidence has been discovered since that time.
Be sure and check out avoidthestemcellscam.com and feel free to contact us directly at avoidthestemcellscam@gmail.com.
I read your website from start to finish when you began posting a lot on here. To be frank, I thought you were Chris Centeno´s ad agency, there were so many reports and video´s from this “stem cell expert”. Of course he has experience, but he is also profiting from the business and cannot be said to provide a truly independent opinion. (and btw he was also told to stop illegal stem cell practices by the FDA as reported on this blog and here, https://www.casewatch.net/fdawarning/prod/2008/regenexx.shtml). Chose your advisors carefully.
You are correct that there are these apparently qualified people scamming the unsuspecting, but it is not difficult to see that they have a vested interest – especially if you are sitting in their practice listening to their spiel – so find an independent qualified medic or three with a background in your illness – if all three say, yes go for it, its proven safe and efficacious – and later it´s proven to be quackery – I´ll pay for your costs myself.
It´s really simple to avoid the stem cell scam – but the downside for many is missing out on the hope, however non-existent a real clinical improvement may be, and for some people the hope is worth the $30,000 outlay so I´m not going to stop them. I advise patients on questions like this, when they´ve read something on the web and need an independent compass: https://www.cochrane.org/
@Diane,
What’s your and Cochrane’s interest in the stem cell arena?
Best, Paul
Hi Paul, Cochrane produces reviews and other reports distilling evidence from clinical trials and other scientific resources into a form that anyone from government agencies to caregivers and patients may understand. Databases like clinicaltrials.gov provide no overview of similar trials not any meta-analyses thereof, so we do this. Teams of clinical specialists chew through the results of many clinical trials to determine whether the evidence is conclusive for a statement of drug effect or whether there are questions still to be answered. This involves understanding the types of clinical trial, their design (e.g. powering), how clinical endpoints are chosen, etc., all of which may influence the take-home message. It is a rigid process and the reports will never be speculative, they only report the evidence-based conclusions. Such analyses can still be quite technical but are way more easy to read than a set of mixed trial reports.
Cochrane has no specific focus on, or vested interest in, stem cell therapies but these are included in a wider range of treatments reviewed. There are currently 41 reviews in the Cochrane library derived from some of the 6500 clinical trials listed in which “stem cells” was a keyword; https://www.cochranelibrary.com/advanced-search?q=stem%20cells&t=6
My personal interest is to create a desk at Cochrane where very high-level (meaning simple to read) evidence-based reports in the stem cell medicine field are generated, to allow caregivers to provide clear factual advice to patients, even though the current evidence for many stem cell interventions is that they are safe within the parameters used in the trial, but ineffective or less effective than standards of care.
Diane: Chris Centeno did stop his practice insofar as making available to his U.S. patients their bone marrow derived stem cells cultured to therapeutic levels. He continued, however, with same day procedures here in the U.S. He took his expanded or cultured stem cell practice overseas into the Grand Cayman Islands (I believe) where the FDA does not have jurisdiction…for now. In other words Regenexx, Chris Centeno’s company/clinic, complied with the FDA’s law. I believe that Centeno and Regenexx tried to sue the FDA claiming that his work, to include the expansion of stem cells in culture, was simply the practice of medicine….not the creation of a drug. Unfortunately (in my opinion) he lost.
I don’t think that doctors like to consider themselves businessmen. But medicine IS a business, (particularly in the States) so by extension are doctors businessmen as well to include Chris Centeno……I personally think that the practice of medicine should not be a business at all. So, in reality nobody in our healthcare establishment,to include doctors, are truly all that independent….not just Chris Centeno. To make matters worse, in this age of public/ private/ partnerships, I don’t believe that the FDA is truly all that independent either.
Douglas, your last line is both disheartening and sadly true. Worse still, whether or not there is independence, if the impression is given that nobody can offer independent opinion, then it will be as good as true as all opinion will be classed as untrustworthy. But whatever the position of Centeno or any expert advisor is, businessman, medic, or both, it is surely sensible to gather information from as many sources as possible to hopefully eliminate the risk of bias or simply lack of expertise, before handing over your cash, and possibly more, to a snake oil salesman.
Unfortunately there appears not to be a shortage of folks who are, at a moment’s notice, ready, willing and able to blame victims of sophisticated scams. People can still be taken in despite the internet and expertise in a particular field. These resources can perhaps make scamming less likely, but you will never get rid of confidence men. And the”best” ones will always find a way of making a living.
Would bone marrow aspirate drawn from a person’s own body work to repair any vertebrae, spinal nerves, annular tears, motor nerve issues or joints if fluoroscopy was used? Would there be a difference between someone who suffered a spinal cord injury several days prior vs someone who may have suffered spinal cord damage several years prior if these procedures were used? What might be some possible results?
If blood comes from bone marrow, does that mean that it might better work for spine or bone issues? I have heard naturopathic doctors say that blood is actually made in the bowel? If that is the case, then how would anything other than in blood to blood transfers have any thing to contribute to other body parts such as bones, vertebrae and joint tissue regenerating?
FYI, it no secret that we were scammed and created a website ( avoidthestemcellscam.com) to help people understand what we did not understand when we fell for a sales pitch where both a DC and an MD lied to our family and said that they were giving us actual living stem cells when it was in reality a HCTP 361 Registered and now ReCalled Product from a company using dead, irradiated birth tissue that also, as it turns out, was never meant for therapeutic use in humans, according to one of it’s own medical advisors. During the sales pitch cleverly disguised as a consultation, the DC mentioned MSCs in the pitch which makes me think that all this placebo/ perceptive based marketing language is just that. Plus, our three family members got zero results, except the eldest who had 2 IVs ended up hospitalized with multiple surgeries from infection similar to the 12 people reporting illness from the same product that the FDA ReCalled.It all seems questionable since the “homologous only” use would not include anything other than blood to blood.
How can you be scammed when any independent medical professional could have told you if the therapy had any solid basis, i.e. proof of clinical benefit? It´s like saying I got scammed because my herbal tea promised to cure my diabetes. At some point the government cannot be made responsible for people who decide to ignore the information provided to them (in this case the openly available FDA websites). The feds can step in to prevent illegal practices but not to compensate for the willful negligence of consumers.
Dick- waiting forever is NOT the plan. The plan IS basing a therapy on scientific evidence and information about what the cells actually do, and not raising false hope.
Note one of Paul’s facts: bone marrow stem cells injected intravenously do not stay in the body- they are gone in a few days at most. They do not turn into any of the cells that make up the spinal cord.
Stem cell therapy is not magic. No drug therapy is. And cells are drugs.
Please Google the word Laetrile.
Hey Dick. While you are at it, Google the term Regulatory Capture. Cells are drugs? , I suppose somebody could make that same declarative statement regarding all of our body parts to include hair, skin, blood, bone etc.. And perhaps folks could be alright with that sort of arrangement too if regulatory agencies in this country were truly working on behalf of the best interests of the majority of the people. I don’t believe that they are. And that includes the FDA who like politicians are working in favor of their donor class…in my opinion.
As far as waiting forever is concerned….. practically speaking the manner in which things are dragged out scientifically, there is little difference between that AND waiting forever. I’m not blaming the scientific community for their perpetual research. They need jobs. They have to provide for themselves and their families. But in our current system perpetual research comes at the expense of some of the most vulnerable among us. Likely we need a different method of paying biomedical scientists…and the FDA.
In this non experts’ opinion, the clinical trial in Japan where expanded adult stem cells are infused into the patient sounds pretty harmless albeit not very practical. I would strongly consider this method for other neurological conditions (like MS) but not in the United States. Clinics here are generally not allowed to expand stem cell cultures to higher therapeutic levels unless they can pay the price for an IND to the FDA. (Not likely) Calling the Japanese trial “dangerous” to me seems unnecessarily alarmist.
. Here’s a question:….What’s wrong with injecting the expanded adult stem cell culture into the site of injury? Answer. (mine)……This sort of treatment should not be relegated to clinical trials. Once a person receives a spinal cord injury, then expanded treatment into the site of injury AND infusion ought to be the first option. (Given what is already known about adult stem cells.) Instead these sorts of long term clinical trials have become the result of the powers that be having made silly declarations about our body parts being drugs. This is not in the interests of vulnerable patients in my opinion.
so you think we should…wait forever? wow great plan.