The US Food and Drug Administration (FDA) yesterday targeted a booming national market for suspect medical treatments, announcing actions against clinics offering questionable stem-cell treatments for cancer and other diseases.
The FDA moved against California Stem Cell Treatment Centers in Beverly Hills and Rancho Mirage; StemImmune Inc of San Diego; and the US Stem Cell Clinic of Sunrise, Florida.
In what it termed as decisive action to protect patients, the FDA on Friday dispatched US marshals to the California clinics and seized close to 500 doses of smallpox vaccine supplied by StemImmune. The vaccine was to be mixed with stem cells taken from patients body fat, for direct injection into patients malignant tumors.
According to the FDAs statement issued Monday, this is an unapproved and potentially dangerous treatment for cancer.
Of the five vials of vaccine, one had been opened and was partially used, the FDA said.
According to the agency, the seizure of the smallpox vaccine was necessary to prevent the use of a potentially dangerous and unproven treatment.
The FDA said it would investigate how StemImmune Inc came to be in possession of the smallpox vaccine, which is not commercially available and is normally reserved for people who are at risk of exposure to smallpox, such as military personnel and healthcare workers.
Meanwhile, the FDA said in a press release, As the vaccine is not commercially available, the FDA has serious concerns about how StemImmune obtained the product for use as part of an unapproved and potentially dangerous treatment. The FDA is actively investigating the circumstances by which StemImmune came to possess the vaccine.
Speaking as a cancer survivour, I know all too well the fear and anxiety the diagnosis of cancer can have on a patient and their loved ones and how tempting it can be to believe the audacious but ultimately hollow claims made by these kinds of unscrupulous clinics or others selling so-called cures, said FDA commissioner Scott Gottlieb, MD.
The FDA will not allow deceitful actors to take advantage of vulnerable patients by purporting to have treatments or cures for serious diseases without any proof that they actually work. I especially wont allow cases such as this one to go unchallenged, where we have good medical reasons to believe these purported treatments can actually harm patients and make their conditions worse.
The seizure comes after recent FDA inspections at StemImmune Inc and the California Stem Cell Treatment Centers confirmed that the vaccine was used to create an unapproved stem cell product (a combination of excess amounts of vaccine and stromal vascular fraction stem cells derived from body fat), which was then administered to cancer patients with potentially compromised immune systems and for whom the vaccine posed a potential for harm, including myocarditis and pericarditis (inflammation and swelling of the heart and surrounding tissues). The unproven and potentially dangerous treatment was being injected intravenously and directly into patients tumors.
Serious health problems, including those that are life-threatening, can also occur in unvaccinated people who are accidentally infected with the vaccinia virus by being in close contact with someone who has recently received the vaccine. In particular, unvaccinated people who are pregnant, or have problems with their heart or immune system, or have skin problems like eczema, dermatitis, psoriasis and have close contact with a vaccine recipient are at an increased risk for inflammation and swelling of the heart and surrounding tissues if they become infected with the vaccine virus, either by being vaccinated or by being in close contact with a person who was vaccinated.
Ive directed the agency to vigorously investigate these kinds of unscrupulous clinics using the full range of our tools, be it regulatory enforcement or criminal investigations. Our actions today should also be a warning to others who may be doing similar harm, we will take action to ensure Americans are not put at unnecessary risk, Gottlieb added. I also urge health care providers, patients and consumers to report these kinds of activities or any adverse events associated with these unproven treatments to the agency through MedWatch.
- 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 to crack down on 'unscrupulous' stem cell clinics ... - August 31st, 2017
- FDA cracks on clinics using unapproved stem cell treatments - Pulse Headlines - August 29th, 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