“Basically, most of those cells are gone within a day after injection, and all the cells are gone within 5 days,” Dr. Researchers have found that a big challenge with using fat- and bone marrow-derived stem cells is that they don’t last when they’re reinjected. “The area in urology where those are being most used is in erectile dysfunction,” Dr. Atala said.Īmong the stem cell sources being studied are fat-derived stem cells and bone marrow-derived stem cells, which are autologous stem cells that providers harvest from patients and inject back into those patients in the same setting. “In reality, PRP is one of the very few treatments right now that can be used without FDA approval, and is being used,” Dr. Platelet-rich plasma (PRP), for example, is a cell therapy-not a stem cell therapy. Not only are stem cell procedures not yet approved in urology and other specialties, but there’s confusion among patients and providers about what stem cell therapies are, according to Anthony Atala, MD, professor of urology and regenerative medicine at Wake Forest School of Medicine, Winston-Salem, NC. Read: System tracks stent insertion, removal in EMR Frow, but there are no FDA-approved stem cell products for conditions in urology and many other specialties. Hundreds if not thousands of clinical trials are currently looking at stem cell use in medicine, according to Dr. Next: The state of stem cell use in urology Brandt did not respond to Urology Times’ request for comment. “Besides adipose-derived cells, additional stem cells and growth factors are sourced from bone marrow concentrate,” according to the site. He uses adipose-derived stem cells for ED, according to the ThriveMD website. Brandt treats joint and back pain, as well as erectile dysfunction. Scott Brandt, MD, the clinic’s medical director, trained as an anesthesiologist. The ThriveMD clinic in Denver and Vail, CO is one stem cell clinic offering urologic services.
Only one, and possibly two, urologists were among the providers at the 169 clinics, according to the report. Frow, PhD, assistant professor in the School for the Future of Innovation in Society and the School of Biological and Health Systems Engineering at Arizona State University, Tempe. “What we found was that clinics treating urologic conditions almost always treated a whole set of other conditions too that were not urologic in nature,” said the report’s first author, Emma K.
offered treatments for urologic conditions, including erectile dysfunction, interstitial cystitis, Peyronie’s disease, and bladder and kidney conditions (Stem Cell Reports 2019 13:247-53). creating potential significant safety concerns that put patients at risk.”Ībout 15% of the 169 stem cell clinics that were the subject of a recent report on the direct-to-consumer stem cell business in the southwest U.S. “The product was then administered to cancer patients with potentially compromised immune systems and for whom the vaccine posed a potential for harm, including the possibility of inflammation and swelling of the heart and surrounding tissues,” the FDA said in a statement.Īs recently as early September, the FDA sent a warning letter to Stemell, of San Juan Capistrano, CA, for “manufacturing and distributing unapproved products derived from umbilical cord blood and umbilical cord and for significant deviations from current good tissue practice (CGTP) and current good manufacturing practice (CGMP) requirements. Providers at the California clinic were injecting cancer patients’ tumors with stem cells from their fat. In May, for example, the FDA announced it was seeking permanent injunctions to stop Cell Clinic of Sunrise, FL, and California Stem Cell Treatment Center, with locations throughout the state, to stop marketing stem cell products without FDA approval and for deviating from good manufacturing practice requirements.Īlso see: How has FDA label change affected treatment of advanced bladder Ca? The agency has tried to regulate stem cell clinics as part of a comprehensive move to oversee regenerative medicine products. The FDA warns that unapproved stem cell therapies can be harmful and may be illegal and unproven ( bit.ly/FDAstemcell). But while there’s hope that cell-based therapies might not only treat symptoms but also modify diseases, including erectile dysfunction, the scientific evidence to show therapies using any stem cells work and don’t cause harm is lacking. Patients with urologic conditions have easy access to stem cell therapy options offered by a spectrum of providers at locations that vary from strip mall clinics to academic centers.
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