Note from Tim Bolen: There has been, for a very long time, a prohibition against anything that (1) competed for drug dollars in the US health care system, or (2) actually made people healthier or fixed specific problems. Let’s call those things “Forbidden Therapies.” You will find articles about them by clicking on the orange box on the right…
Everyone has heard of stem cell therapies, but few know much about the controversy and the reasons why we DO NOT HAVE a stem cell program in the US. But I, Tim Bolen, know why, and I am, with the assistance of some stem cell expert friends of mine, like David Steenblock DO, and Rick Jaffe Esq., going to tell you what’s REALLY going on.
In short stem cells are magnificent. They repair damage to the body – bones, brains, muscle tissue – everything. Scientific proof, around the world, abounds. There is NO SCIENTIFIC ARGUMENT against them – THEY WORK. So why aren’t we embracing this technology in the US? Pure, unadulterated, greed and public malfeasance.
The controversy over stem cells is because there are two kinds of stem cells – embryonic and adult. (1) Embryonic stem cells are PATENTABLE and would make BIG Pharma another massive fortune. (2) Adult stem cells are natural, work extremely well, but THERE is NOTHING to patent.
Embryonic stem cells are made from aborted fetal tissue, and although Big Pharma thought that would NOT be a problem, Americans, at large, had a problem with throwing unborn babies in a blender. So, embryonic technology fell flat – thud.
Adult stem cells are gathered from tissue easily harvested from various parts of the human body. Read about how this works here. A popular source is an umbilical cord after the baby is born. A short explanation is that about 50,000-70,000 stem cells come from a cord. Then, those cells are put into a growth medium in a specialized lab for about two weeks where there is an end output of 50 million stem cells – and THEN you have an effective tool to repair damaged areas of the human body. Different growth mediums produce different stem cell types for different uses. MORE, and VERY important, is that adult stem cells sort of look around in the body and fix other broken stuff at the same time…
The key to adult stem cell efficiency is in the growth and management in the lab. Of course the US FDA FORBIDS the growth of adult stem cells in the lab claiming that that growth process is “A New Drug.” They want each doctor, and the lab, to spend 1.8 billion dollars going though THEIR process for EVERY patient.
Which leaves, in the US, only one adult stem cell therapy legal for use – the one where the patient’s own stem cells are harvested and re-inserted with no growth or intervention at all. To me, it is the LEAST effective stem cell treatment on Planet Earth – but still effective to some extent. The US FDA is, of course, trying to have anyone and everyone offering this therapy arrested and shot…
But the Trump administration has OTHER ideas. (smile here). And that’s why I enlisted David Steenblock DO to tell you about how it all works.
In the article below I have inserted a video clip from Vice TV about this subject. Vice, it appears to me, was trying to denigrate the use of adult stem cells by repeatedly insisting that “they are unproven and are a placebo effect, blah, blah, blah.” If you look at, and listen, closely to what the video interviewer is saying it becomes obvious that he was engaging in what our President Donald Trump rightfully describes as “Fake News.” He, obviously had no idea what “unproven” means, nor did he know what a “placebo effect” actually is.
But, the reporter made THREE very important points, one of which is that the new Trump administration WANTS stem cells…
So do I. So do you..
So, here we go…
Adult Stem Cell Therapies for Cerebral Palsy: Fact or Fiction?
“Cerebral Palsy (CP) is a disability resulting from damage to the brain before, during, or shortly after birth. It is outwardly manifested by muscular dis-coordination and speech disturbances. CP brain damage is very similar to that in Autistic children.”
One of the favorite tactics used by critics and dogmatic skeptics of integrative medicine, and especially adult stem cell therapies, is to call them “unproven” and to call positive patient responses “placebo effects”. Both terms have been applied ad nauseum to pioneering clinical work and the many patient turnarounds I, and others, have reported (over the past forty years of medical practice).
“Unproven” and “placebo” were most recently brought up with respect to my stem cell work during the fall of 2016 when a cable news crew (Vice) came to my clinic in San Clemente (California) to film a pediatric patient’s treatment for cerebral palsy1 which included the use of the boy’s own stem cell-rich bone marrow (A wholly legal form of “stem cell therapy”).
Although the film crew spent the better part of a day at my Personalized Regenerative Medicine clinic, the edited online version ran 7 minutes and 11 seconds. See it just below…
Towards the end of the episode a male interviewer sat and spoke with me concerning reports of impressive patient responses to the stem cell therapies I do.
While the interviewer admitted it was impossible to deny the reality of the many patient’s positive responses to stem cells, he challenged me to prove that all of these positive results were not merely due to “placebo“ and wishful thinking on the part of the parents. At this point I interjected that “if the great results I am having with stem cells are due to a “PLACEBO” then this is one placebo (STEM CELLS), I want to keep using!”
The eight (8) minute video below, titled “Cerebral palsy patients are spending thousands on unproven stem cell therapies,” appeared on Vice News HBO on November 30, 2016.
I have seen far too many turnarounds that cannot be explained by placebo effects. In a January article titled “Update on the US Stem Cell Wars“ (BolenReport), I laid this out in no uncertain terms:
“It is important to keep in mind that placebo effects have not been shown to permanently improve a dire illness or medical condition. They can lessen a patient’s perception of pain or nausea and other symptoms, but not pull off the “miraculous” PERMANENT reversal of a chronic debilitating condition like CP since these PLACEBO effects only last three to four weeks! (1,2,3,4,5,6)
“This brings me to how academic researchers (mostly lab people working with mice and rats) and journalists have dismissed patient accounts of impressive physical improvements as wishful thinking or placebo effects. It is actually mindboggling that scientists, in particular, would call physiological, neurological and other turnarounds “wishful thinking” or the end result of “placebo effects”. Do they really believe, for instance, that a young boy who is cortically blind from birth and then recovers some of his ability to see following a stem cell treatment (in Mexico) experienced this due to wishful thinking, placebo effects or coincidental betterment?
And while a patient, parent or caregiver might indulge in “wishful thinking” in the sense of inflating a minor improvement into something else, what of those who document changes of a magnitude not seen in their child prior to the administration of stem cells?
My stem cell related work with cerebral palsy and many other neurologic issues goes back to the early 2000s (albeit I did experimental work in the US and Mexico in the early 1990s that set the stage for his subsequent stem cell work.
See side bar titled “More on how Drs. Steenblock & Ramirez forged a collaboration that advanced the field of stem cell therapies“).
In fact, the staff of my nonprofit namesake research institute in San Clemente and I collaborated with a highly respected Mexican orthopedic surgeon, Fernando Ramirez Del Rio, MD, in tracking and documenting the responses of pediatric and adult patients treated by Ramirez and his medical team in Mexico using pure umbilical cord stem cells.
The treatment outcomes of neurologic patients in particular was so impressive that my staff and I worked with Ramirez to design and execute a clinical study to gauge the effects of using pure umbilical cord stem cells on eight (8) children with cerebral palsy.
As part of this study improvements were gauged by the children’s parents who kept diaries and used medical and physical therapy check-ups to categorize and quantify change.
Eight out of eight children showed some significant improvements in mobility and/or mental (cognitive) function.
Six children (75%) showed improvements in muscle tone, hip movement, leg movement, and much more. And one little boy named Adam S. who went into study “cortically blind” (due to optic nerve hypoplasia) began tracking objects during the fourth month following his stem The study was published in the journal Medical Hypotheses & Research (Click to access) and was then included in a book I coauthored titled “Umbilical Cord Stem Cell Therapy: The Gift of Healing from Healthy Newborns” (2006, Basic Health Publications).
In the years since that pioneering study the “good news” concerning adult stem cells and CP continued to accrue. For instance, to-date more than five (5) children with “cortical blindness” have experienced a resolution of their condition, many being so improved that they were subsequently fitted with prescription eyeglasses and begin doing what visually unimpaired children do.
And numerous children who were battling seizures experienced a significant reduction in these following their stem cell treatment. A few stopped having seizures altogether.
There Certainly Is a Track Record…
It would seem that in some instances “proven” includes procedures, biologics and other things in medicine that have been used long enough to leave a substantial track record of safety and efficacy.
Given the literally thousands of off-label umbilical cord stem cell treatments done worldwide in just the past fifteen years which have demonstrated both safety and effectiveness in remediating a whole host of medical diseases and conditions, perhaps it would be fairer to characterize them not as “unproven”, but as “provisionally” or “tentatively” proven — or validated.
And given the fact I and other physician’s have achieved comparable or better clinical outcomes using stem cell-rich bone marrow aspirate concentrate (BMAC) to treat cerebral palsy and other medical conditions, perhaps “provisionally” or “tentatively” proven is a label that should be applied to them as well.
The Bottom Line…
But whether called proven or unproven, the fact remains that both off-label umbilical cord and bone marrow stem cell treatments have produced clinical responses that reflect biological, physiological and neurological improvements which cannot be attributed to placebo effects or wishful or magical thinking.
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2: Rains JC, Penzien DB. Behavioral research and the double-blind placebo-controlled methodology: challenges in applying the biomedical standard to behavioral headache research. Headache. 2005 May;45(5):479-86. Review. PubMed PMID: 15953264.
3: Berkman ND, Santaguida PL, Viswanathan M, Morton SC. The Empirical Evidence of Bias in Trials Measuring Treatment Differences [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2014 Sep. Available from http://www.ncbi.nlm.nih.gov/books/NBK253181/ PubMed PMID: 25392898.
4: Colagiuri B. Participant expectancies in double-blind randomized placebo-controlled trials: potential limitations to trial validity. Clin Trials. 2010 Jun;7(3):246-55. doi: 10.1177/1740774510367916. Review. PubMed PMID: 20421243.
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6: Haahr MT, Hróbjartsson A. Who is blinded in randomized clinical trials? A study of 200 trials and a survey of authors. Clin Trials. 2006;3(4):360-5. Review. PubMed PMID: 17060210.
© 2017 by David A. Steenblock, D.O., Inc. All rights reserved.