The U.S. Food and Drug Administration (FDA) said on Monday that it would take severe measures after it found that clinics around the country are selling unapproved and potentially dangerous stem cell treatments to patients with cancer and other hard diseases, according to a warning letter posted by the agency.
The crackdown was announced due to hundreds of clinics around the country selling unapproved stem cell therapies, but two of them were specifically pointed: the U.S. Stem Cell Clinic of Sunrise, Florida; and California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills. In the last one, certain doctors carried out a surgery where they injected a smallpox vaccine intravenously and directly to the patients tumors.
Many of these patients have suffered great harm, and even death as a result of using unproven stem cell therapies, the President of the International Society for Stem Cell Research, Hans Clevers, said in a statement. We are hopeful that increased regulatory enforcement against clinics offering unproven treatments will deter this practice and help protect patients.
On Monday, the FDA posted on its web page a warning letter sent last week to U.S. Stem Cell Clinic of Sunrise, Florida. In it, the agency condemned the selling of unapproved stem cells treatments, which doctors injected intravenously and directly into the patients spines. Previously, according to a report published by the New England Journal of Medicine, this Florida clinic was already linked with three women who ended up blind after they were subjected to a fat-stem cell treatment for macular degeneration.
However, this is just one of many other clinics around the country that the agency accused to use stem cells vaccines to treat different conditions, such as cancer, Parkinsons disease, amyotrophic lateral sclerosis (ALS), and lung and heart diseases.
Along with it, on the same Monday, the agency announced that last week it accused StemImmune Inc. of San Diego to purchase five live virus vaccine vials, previously designated to only those patients who were at high risk of smallpox. At the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, the vaccines were later combined with stem cells extracted from patients fat and injected directly to patients tumors.
Ive directed the FDA to launch a new working group to pursue unscrupulous clinics through whatever legally enforceable means are necessary to protect the public health, The FDA commissioner, Dr. Scott Gottlieb wrote in a statement. We have examples where some of these unproven treatments have clearly harmed patients.
Doctors might offerunapproved stem cells therapies, and people under high-risk diseases might accept them without having a second thought. This is why the FDA published a series of advice for safe before they choose an unproved and dangerous treatment instead of a secure and adequate therapy.
If you see a business thats making all sorts of dramatic marketing claims across disease categories, claiming to use fat as a treatment for all sorts of indications, these are all signs to be wary of, said Leigh Turner, associate professor at the Center for Bioethics at the University of Minnesota.
According to Turner, it is not easy for patients to either recognize which treatment would be good and beneficial for them, or which one would be totally dangerous.
- BEYOND LOCAL: Expert recommends 'path of cautious optimism' about the future of stem cell treatment - CollingwoodToday - October 12th, 2019
- BEYOND LOCAL: Expert recommends 'path of cautious optimism' about the future of stem cell treatment - NewmarketToday.ca - October 10th, 2019
- Tech review: Apps that enhance cellphone battery performance - Newsday - October 10th, 2019
- Better solutions for the replacement of joints - SciTech Europa - September 28th, 2019
- Opinion: Kudos to Google for banning stem cell ads. Other tech companies should follow - Yahoo News - September 24th, 2019
- Google banned ads for stem cell treatments. Others should follow - STAT - September 24th, 2019
- Global Canine Stem Cell Therapy Market Data Analysis, Growth, Demand & Forecast 2019-2024: VETSTEM BIOPHARMA, Cell Therapy Sciences, Regeneus,... - September 24th, 2019
- Global Stem Cell Cartilage Regeneration Market Size, Development Plans and Forecast to 2028 - Analytics News - September 24th, 2019
- Amyotrophic Lateral Sclerosis (Lou Gehrigs Disease) Treatment Market Size, Status and Growth Opportunities by 2016 2022 - Analytics News - September 24th, 2019
- 'Stem cell' therapies offered at private clinics need to ... - May 22nd, 2019
- FDA Mounts Aggressive Push to Regulate Stem-Cell Clinics ... - May 16th, 2019
- FDA cracks down on stem cell clinics - CNN - April 29th, 2019
- Private clinics peddling of unproven stem cell treatments ... - April 29th, 2019
- Stem cell clinics make big claims but offer little ... - April 1st, 2019
- UCLA UCI Alpha Stem Cell Clinic | UCLA Broad Stem Cell Center - April 1st, 2019
- Stem cell clinics sued | Regenerative Medicine Foundation - April 1st, 2019
- Patients fleeced by overseas stem cell clinics? Now it ... - April 1st, 2019
- Stem Cell Clinics - eureka - February 15th, 2019
- Mayo Clinic finds surprising results on first-ever test of ... - February 15th, 2019
- Stem Cell Transplant in Germany: Clinics, Cost, Price ... - February 15th, 2019
- Stem Cell Therapy Chicago Illinois, Buffalo Grove ... - January 23rd, 2019
- Stem cell therapy: FDA investigates clinics offering ... - January 11th, 2019
- Stem cell market: Inside California's flourishing for ... - December 24th, 2018
- FDA Wants To Tighten The Screws On Stem Cell Clinics ... - December 24th, 2018
- Meet Our Doctors - Rejuva Stem Cell Clinic - December 24th, 2018
- What Stem Cell Clinics Do You Trust? | BioInformant - November 5th, 2018
- Stem cell laws - Wikipedia - October 17th, 2018
- FDA: Florida Stem Cell Clinic Violates Law | Health News Florida - September 15th, 2018
- Patients guide to treatments - The Niche - July 14th, 2018
- Adult Stem Cell Therapy in Utah Docere Clinics - October 18th, 2017
- At ClinicalTrials.Gov, Untested Stem Cell Clinics ... - October 13th, 2017
- Stem Cell Therapy and Its Revolutionary Purposes Guardian ... - Guardian Liberty Voice - September 4th, 2017
- Canadian clinics begin offering stem-cell treatments ... - September 3rd, 2017
- FDA cracks down on clinics selling unproven stem cell therapies - Gears Of Biz - September 3rd, 2017
- FDA to crack down on 'unscrupulous' stem cell clinics ... - August 31st, 2017
- FDA cracks down on clinics selling unapproved stem cell therapies - CBS News - August 29th, 2017
- Stem cell treatment potential in Canada - IMTJ - August 20th, 2017
- Dozens of US clinics sell unproven stem cell therapies for heart failure - Fox News - July 30th, 2017
- Broomfield's Regenexx in merger with Iowa company - Longmont Times-Call - July 12th, 2017
- North Central Texas Stem Cell Clinics in conjunction ... - July 9th, 2017
- Private clinics' peddling of unproven stem cell treatments is unsafe and unethical - Medical Xpress - July 8th, 2017
- Stem Cell Therapy - Cendant Cellular Therapies - Denver ... - November 30th, 2016
- Stem Cell Clinics Questions to Ask - National Multiple ... - September 23rd, 2016
- CIRM Alpha Stem Cell Clinic - UCSD Stem Cell Program - September 18th, 2016
- Treatment Abroad | Canadian Stem Cell Foundation - September 18th, 2016
- Hundreds of U.S. clinics are selling unapproved stem cell ... - August 31st, 2016
- First stem cell treatment for human administered in Atlanta ... - August 20th, 2016
- Stem Cell Clinics : National Multiple Sclerosis Society - September 29th, 2015
- Adult Stem Cell Banks and Clinics Marketing Stem Cell ... - September 25th, 2015
- Stem cell clinics, FDA, and giant, unapproved for-profit ... - September 25th, 2015
- Predatory stem cell clinics are winning the war; what can ... - September 22nd, 2015
- Stem Cell Therapy Clinics In Canada | Stem Cell Medical ... - August 2nd, 2015
- Stem Cell Clinics List | Stem Cells Freak - May 30th, 2015