CHICAGO, Ill. (Ivanhoe Newswire) — You name the pain, and a stem cell clinic seems to be springing up to fix it, from knee pain to glaucoma. But some of these clinics may be too good to be true and could even be dangerous.
On a day off from filling cavities, Robert Radin was drilling drive after drive off the tee, when all of a sudden …
“I was having trouble as usual with my golf swing and I was really swinging kind of hard and I felt something move in my hip and it kind of didn’t feel right,” explained Robert.
Robert discovered he had mild arthritis of the hip. He tried the usual physical therapy and medication, but nothing helped. Then …
Robert continued, “Reading as everybody does about regenerative medicine, stem cells … I started thinking this is kind of where I think medicine is going to.”
Shane J. Nho, MD, Midwest Orthopaedics at Rush says, “So there is a wide range of biologic treatments that are available right now.”
Such as injected stem cells to decrease inflammation or promote healing. This has many people flocking to clinics for cures ranging from back pain to Parkinson’s. In 2016, more than 570 clinics were offering stem cell treatments. The problem?
Frank Phillips, MD, Midwest Orthopaedics at Rush shared, “I would push them, ask them to see real results, real studies, real data rather than just trust the promise that somehow these stem cells are miraculously going to cure your back pain.”
The stem cell therapies that have not been thoroughly tested and approved by the FDA could actually pose danger to patients. Dr. Nho says there are two things you need to pay attention to …
“First of all, you want to be aware of a couple of things. One is excessive advertisement. The other thing is excessive cost,” stated Dr. Nho.
Dr. Nho cautions viewers to ask hard questions about costs and proof of results early.
California leads the way with the most stem cell clinics at 113. Florida comes in second with 104 and Texas third with 71. One recent report found 18 companies that have registered patient-sponsored stem cell studies on clinicaltrials.com.
Contributors to this news report include: Julie Marks/John Cherry, Producer; Roque Correa, Editor.
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STEM CELL TREATMENTS: BUYERS BEWARE!
BACKGROUND: Stem cells have the remarkable potential to develop into many different cell types in the body during early life and growth. In many tissues, they serve as a sort of internal repair system, dividing essentially without limit to replenish other cells as long as the person or animal is still alive. When a stem cell divides, each new cell has the potential either to remain a stem cell or become another type of cell with a more specialized function, such as a muscle cell, a red blood cell, or a brain cell. Stem cells are distinguished from other cell types by two important characteristics. First, they are unspecialized cells capable of renewing themselves through cell division, sometimes after long periods of inactivity. Second, under certain physiologic or experimental conditions, they can be induced to become tissue, or organ-specific, cells with special functions. Stem cell research is one of the most fascinating areas of contemporary biology, but, as with many expanding fields of scientific inquiry, research on stem cells raises scientific questions as rapidly as it generates new discoveries.
STEM CELL CONTROVERSY: Today, doctors routinely use stem cells that come from bone marrow or blood in transplant procedures to treat patients with cancer and disorders of the blood and immune system. With limited exceptions, investigational products must go through a thorough FDA review process as investigators prepare to determine the safety and effectiveness of products in well-controlled human studies, called clinical trials. The FDA has reviewed many stem cell products for use in these studies. As part of the FDA’s review, investigators must show how each product will be manufactured so the FDA can make sure appropriate steps are being taken to help assure the product’s safety, purity, and potency. The FDA also requires sufficient data from animal studies to help evaluate any potential risks associated with product use. That said, some clinics may inappropriately advertise stem cell clinical trials without submitting the proper “Investigational New Drug Application” (IND). Some clinics also may falsely advertise that FDA review and approval of the stem cell therapy is unnecessary. When clinical trials are not conducted under an IND, it means that the FDA has not reviewed the experimental therapy to help make sure it is reasonably safe.
NEWEST STEM CELL RESEARCH: The University of Copenhagen and Novo Nordisk published new research in the scientific journal Stem Cell Reports that provides a better understanding of how to improve the production of beta cells from human embryonic stem cells. By reprogramming skin cells into nerve cells, researchers are creating cell models of the human brain. In another new study published in Molecular Psychiatry, researchers describe how cells from patients with the severe developmental disease, lissencephaly, differ from healthy cells. The method can provide vital new knowledge on difficult-to-study congenital diseases and how to treat them. Finally, a study was developed by researchers at the University of Rochester Medical Center which is the first to demonstrate hallmarks of macular degeneration in a new human stem cell model. Click here to read about the non-FDA approved, but cleared for use, procedure in this story, http://nutechmedical.com/products/renu/.
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