More Risks on Stem Cell Injections
Many patients and their doctors are hoping against all hope that these stem cell injections will work. I too hope and pray these stem cell injections will work if injected into the meibomian gland. However, it has never been tried and there are still big concerns.
While we proceed with submitting an IRB for our research for Stem Cell Injections into Meibomian Glands (STIM) and look for funding (in efforts to avoid charging patients) it is important for all patients to know the risks before they agree to have any stem cell injection.
In the meantime, if anyone knows of a generous donor who wants to help us get to the bottom or whether stem cells work or not for Meibomian Gland Disease, please let us know. Our alternative is to charge patients per treatment likely around $5000, which we prefer not to do. Currently, our protocol is to treat only one eye’s upper and lower lid and use the non-treated eye’s lids as controls.
Still if I had a loss of glands and chronic eye pain, I would pay this to see if it works, knowing the risks we currently know and knowing that all the risks may not even be known by researchers. I know that once the glands are scarred, there is less of a chance even STIM will work so I would want to be injected while I have even a stub of Meibomian Gland visible on Meibography. But we do not know if STIM will not work on fully scarred glands. The only thing we do know is that if one has fully scarred glands, the cornea will suffer from chronic signs of dryness and scar will eventually develop on the cornea which can decrease vision in some patients, lead to chronic eye pain in many, and loss of vision in others as well.
Please let me know if you want to be put on our list of patients to contact regarding STIM. Patients from around the country are contacting me to ask about this procedure. Please encourage your friends and family to donate to Visionary Eye Foundation via Paypal. It is tax deductible. I did a medical/surgical mission trip to Bolivia with their help. They do surgical missions to help blind children and adults yearly, so it is worthy project which I also donate to every year. They will likely be able to help us with a grant for this project.
The below articles are a must read for anyone considering any type of Stem Cell injection. Stem Cell Injections is the wild frontier of medicine. My advisor Dr. Judah Folkman at Harvard often said that his work on angiogenesis was like the wild frontier of medicine. He was laughed out of many national meetings in his attempt to show that angiogenesis was the basis for cancer growth and metastasis. The biggest issue with Stem Cell injections is the lack of definitive proof it works and the fact that most patients have to pay out of pocket for this still not fully proven technology. Still there are many patients that tell me they were able to avoid surgery after a stem cell injection. Is this true? Is it a placebo effect? Where is the cellular proof? With Meibomian Gland Stem Cell Injections (MeGSCI), we will have proof of “yes it works” or “no it does not” with meibography photos pre and post injection.
Sandra Lora Cremers, MD, FACS
Stem Cell Soup – The Importance of Knowing What Is In It
“I don’t even know what’s in the soup,” was the shocking quote from the founder of a chain of clinics highlighted in a recent Associated Press article about the increasing prevalence of clinics offering unproven stem cell therapies. The “soup” referred to the mixture of cells and fluid he extracted from a patient’s fat for re-injection into the same patient’s knees, one of many “stem cell” procedures being tried for more than 20 diseases and conditions.
Clinics that offer such “soup” and other so-called “stem cell treatments” that have not been rigorously tested have been the focus of considerable attention lately. In recent months, two highly-publicized scientific reports document the rapid, world-wide, growth of such clinics. In the U.S., the Food and Drug Administration (FDA) released draft guidance documents to clarify regulatory expectations, including that cells harvested from fat and introduced into a different part of the body are subject to FDA oversight, and held a public hearing in September to hear comments on the proposed guidance.
The FDA hearing was a chance for the ISSCR and others to reiterate the importance of regulating stem cell treatments, including those using one’s own cells. The reasons why unproven treatments are still available for sale is nuanced. However, the widespread scientific concerns that these unproven treatments continue to proliferate in the absence of rigorous scientific support are not.
A fundamental concern is the lack of characterization of these treatments. This begins with the use of the term “stem cells.” Cells should only be defined as stem cells if rigorous criteria are met: a demonstrated capacity to self-renew (to give rise to more stem cells) and to give rise to specialized cell types such as blood cells or muscle cells.
This issue is particularly concerning as it relates to the use of the term “mesenchymal stem cells” (MSCs) to describe the desired cells extracted from a patient’s fat. Not only is there considerable skepticism in the field about whether these MSCs manifest so-called “stemness” but there is no way to know how many MSCs are even in the “soup” extracted from fat.
The identification of MSCs requires the cells to be grown in a laboratory for days under special conditions or the use of specific MSC markers to identify and isolate them, although the reliability of these markers is still being debated. What this means for the patient is that the same-day treatments with the “soup” are likely to be a mixture of fat and other specialized cell types with no reliable information on whether MSCs are present and if so, how many are present.
Additionally, stem cells from different tissues have different functions and there is still debate about whether MSCs from all tissue sources (fat versus bone marrow, for example) have the same properties. Furthermore, research on other adult stem cells has shown that stem cells can decline in frequency and function as they age. How these and other biological factors might influence the effects of MSCs is unknown.
The lack of rigorous evaluation of the “soup” and similar “treatments” raises many questions that can only be addressed by rigorous scientific study and clinical trials. Authentic patient testimonials can highlight individual results, but they fail to capture all patients’ experiences, and thus fail to give a complete assessment of the therapy. This commercial marketing strategy is reminiscent of the infomercials where an enthusiastic user excitedly promotes the product’s benefits while the small print at the bottom of the screen reads, “results may not be typical.”
The increase of purported stem cell treatments with little to no evidence of clinical utility, and in some cases a disregard of the known cell- or tissue- biology, has led many scientific organizations to take action. The ISSCR has released updated professional guidelines for its members and the stem cell community that contain explicit condemnation of “…unproven stem cell-based interventions outside of the context of clinical research…” Other organizations, such as the American Thoracic Society, the Australasian College of Sports Physicians, among other groups, have released cautionary statements that speak to specific unproven treatments within their specialty areas.
The ISSCR has also developed an informational website, a CloserLookatStemCells.org, designed to help people understand the basics of stem cell science and more. It provides facts about the research and probative questions to consider when evaluating potential clinical trials or stem cell interventions.
Stem cells offer the potential to treat many intractable disease and injuries but there is still a lot to learn about their therapeutic potential. The clear path forward for this relies upon rigorous testing of the safety and effectiveness of the potential treatment in clinical trials and the sharing of experimental and clinical data to ensure that clinical applications are evidence-based.
2. This article also points out the experimental nature of stem cell injections.