A lesson for our graduate students.
A story published July 2, 2016, and purporting to be ‘News”, is entitled: “Unregulated Stem Cell Market Thriving in US, Finds Study”
The news report was published by Perfscience.com: http://perfscience.com/content/2144313-unregulated-stem-cell-market-thriving-us-finds-study and the complete article is here: UnregulatedClinicsThriving
The author and all persons quoted are concerned that they found “351 businesses are providing stem cell treatment from 570 clinics in America. Most shocking part is that these clinics advertise often unproven stem cell treatments for chronic diseases… Without any peer-reviewed evidence, these business and clinics claim that their therapies can treat any of diseases and injuries, including joint pain, autism, spinal cord injuries and breast augmentation.”
The “story” goes on to report:
“The researchers said that there is no doubt that the stem cell does hold bright future for many types of treatment. But till date, juts one stem cell treatment has been scientifically verified and approved by the FDA. It involves stem cells from bone marrow or blood being used in transplants to treat cancers and other diseases that affect the immune system and blood.
Those clinics that have been using these approved treatments could be safe and are following the FDA rules. The researchers mentioned that there are no approved stem cell treatments for muscular dystrophy, autism or cerebral palsy. In fact, some labs are just considering to start research in those areas.
The researchers think that the clinics have been taking out advantage of parents who want to treat their children suffering with incurable conditions. “This kind of advertising reveals another tangled knot of ethical and legal concerns, as the apparent target audience for such marketed interventions is not adults with decision-making capacity but rather the parents or guardians of children”, said the researchers.
From the study, the researchers have come to know about many clinics that have made false claims that stem cells can treat and cure a wide range of health problems.
Leigh Turner, a bioethicist at the University of Minnesota, and Paul Knoepfler, a stem cell researcher at University of California, Davis, said that many of the clinics have simply escaped the regulations. But with advancement in the stem cell industry, the FDA is now adopting stricter role and coming up with a draft guidance that would classify most stem cells using in clinics as drugs, which would require stringent approval laws.
Dr. Aaron Berkowitz from Brigham and Women’s Hospital in Boston said that the unregulated stem-cell industry is harmful for patients and also affects genuine studies on stem cell therapies in clinical trials.
It is important to note that even if real stem cells are used, there is always danger involved. Stem cells can increase in size wildly and cause tumors to grow. In fact, the researchers have even warned about stem cell tourism, in which people for stem cell treatment travel to clinics in different nations, where stem cell cures are offered. The researchers cited a case of a stroke patient who traveled to clinics in China, Argentina and Mexico. He has spent hundreds of thousands of dollars on different stem cell treatments. But the end was a painful growth on his spine.”
So, what is really going on here? Just more scare tactics and misinformation from the “Embryonic Stem Cells Are Better Than Adult Stem Cells” crowd, jealous of the recent movement in America, spurred on by American physicians wanting to treat their patients, to ABANDON embryonic stem cells from any role in therapy and using adult stem cells with genuinely amazing results. Of course, little does the reader of this essay know that adult stem cells have been used overseas for over 15 years to treat some of the most debilitating diseases.
To date, there are hundreds of adult stem cell therapies available worldwide, and increasely in the USA. But NOT ONE therapy using embryonic stem cells. Like we say to our students in one of our courses: If you can find any study whatsoever that successfully used Embryonic Stem Cells for any patient treatment, please share it with the class and collect your “A” for the course. Good luck with that.
Possibly the author and all of those cited in the article are unaware that there are almost 1000 completed clinical trials using Adult Stem Cells according to the US government website: www.clinicaltrials.gov.
Or possibly the author and all of those cited are unaware that patient treatment with Adult Stem Cells can proceed any time in the US, by any physician and for any patient under any one of three criteria approved by the FDA:
“Patient Sponsored” study: Where a physician or company attempts some treatment modality with autologous stem cells and instead of government sponsorship, the patients pay for the study, usually a relatively small amount, and EVERY patient receives the treatment!!
“Open Label” study: When you look at masking, they say, “open label”. Which means no randomized or double blind study, but rather, both physician and patient know they are receiving the adult stem cell treatment and what the treatment is.
“IRB” approval, which stands for Institutional Review Board. If a physician can get institutional review board approval, like from any hospital or non-profit, or maybe even for-profit entity, one can conduct a patient study without specific FDA approval!!!!!!
Please note that these three mechanisms fall within appropriate FDA rules and regulations, and so, are completely legal. Some brilliant people just read the rules carefully and came up with these three wonderful exceptions. Many of the studies under these exceptions are using adult stem cells from cord blood and placental tissue products, which can be used for any patient without immunological consequences.
We also find it strange that except for the US, most countries have already approved adult stem cells as the new treatment modality.
Based on the above, we doubt that any clinic in the US treating patients with adult stem cells is “unregulated”. In fact we can confidently state: “There is no unregulated stem cell market”!!
So, many thanks to all of the true clinicians and caring physicians out there who are doing their best to treat their many patients with severe debilitating diseases. Drugs never got the job done, so they are experimenting and learning as they go just how to use this “new medicine” which is Adult Stem Cells. And all for the greater good!!
The Panama College of Cell Science offers a nice affordable graduate program in stem cell biology, well suited to working adults such as lab technicians, clinicians, clinic administrators, and those interested in academia. Our three year program may be just the ticket for many students who want to expand their knowledge of stem cell science, particularly with respect to the clinical uses of adult repair stem cells, but do not have the time or funds needed to complete a program such as that offered by the the Stanford University School of Medicine.
If interested applicants will view our curriculum, you will find an exciting, novel, and very interesting biology PhD program. Mention “stem cells” and everyone turns to listen. The graduate program at Panama College of Cell Science will give you the tools to become an expert in this new field.
A 3-year totally online PhD program in the new biology: stem cell science….
That is what the Panama College of Cell Science is all about.