The Food and Drug Administration is cracking down on "unscrupulous" clinics selling unproven and potentially dangerous treatments involving stem cells.
Hundreds of clinics around the country have started selling stem cell therapies that supposedly use stem cells but have not been approved as safe and effective by the FDA, according to the agency.
"There are a small number of unscrupulous actors who have seized on the clinical promise of regenerative medicine, while exploiting the uncertainty, in order to make deceptive, and sometimes corrupt assurances to patients based on unproven and, in some cases, dangerously dubious products," FDA Commissioner Scott Gottlieb said in a statement Monday.
The FDA has taken action against clinics in California and Florida.
The agency sent a warning letter to the US Stem Cell Clinic of Sunrise, Fla., and its chief scientific officer, Kristin Comella, for "marketing stem cell products without FDA approval and significant deviations from current good manufacturing practice requirements."
The clinic is one of many around the country that claim to use stem cells derived from a person's own fat to treat a variety of conditions, including Parkinson's disease, amyotrophic lateral sclerosis (ALS), and lung and heart diseases, the FDA says.
The Florida clinic had been previously linked to several cases of blindness caused by attempts to use fat stem cells to treat macular degeneration.
The FDA also said it has taken "decisive action" to "prevent the use of a potentially dangerous and unproven treatment" offered by StemImmune Inc. of San Diego, Calif., and administered to patients at California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, Calif.
As part of that action, the U.S. Marshals Service seized five vials of live vaccinia virus vaccine that is supposed to be reserved for people at high risk for smallpox but was being used as part of a stem-cell treatment for cancer, according to the FDA. "The unproven and potentially dangerous treatment was being injected intravenously and directly into patients' tumors," according to an FDA statement.
Smallpox essentially has been eradicated from the planet, but samples are kept in reserve in the U.S. and Russia, and vaccines are kept on hand as a result.
But Elliot Lander, medical director of the California Stem Cell Treatment Centers, denounced the FDA's actions in an interview with Shots.
"I think it's egregious," Lander says. "I think they made a mistake. I'm really baffled by this."
While his clinics do charge some patients for treatments that use stem cells derived from fat, Lander says, none of the cancer patients were charged and the treatments were administered as part of a carefully designed research study.
"Nobody was charged a single penny," Lander says. "We're just trying to move the field forward."
In a written statement, U.S. Stem Cell also defended its activities.
"The safety and health of our patients are our number one priority and the strict standards that we have in place follow the laws of the Food and Drug Administration," according to the statement.
"We have helped thousands of patients harness their own healing potential," the statement says. "It would be a mistake to limit these therapies from patients who need them when we are adhering to top industry standards."
But stem-cell researchers praised the FDA's actions.
"This is spectacular," says George Daley, dean of the Harvard Medical School and a leading stem-cell researcher. "This is the right thing to do."
Daley praised the FDA's promise to provide clear guidance soon for vetting legitimate stem-cell therapies while cracking down on "snake-oil salesmen" marketing unproven treatments.
Stem-cell research is "a major revolution in medicine. It's bound to ultimately deliver cures," Daley says. "But it's so early in the field," he adds. "Unfortunately, there are unscrupulous practitioners and clinics that are marketing therapies to patients, often at great expense, that haven't been proven to work and may be unsafe."
Others agreed.
"I see this is a major, positive step by the FDA," says Paul Knoepfler, a professor of cell biology at the University of of California, Davis, who has documented the proliferation of stem-cell clinics.
"I'm hoping that this signals a historic shift by the FDA to tackle the big problem of stem-cell clinics selling unapproved and sometimes dangerous stem cell "treatments" that may not be real treatments," Knoepfler says.
See the original post:
FDA Cracks Down On Stem-Cell Clinics Selling Unapproved Treatments - Delaware First Media
- Japan Stem Cells Market to be at Forefront by 2028 - November 24th, 2022
- Mice Model Technologies Market Outlook, Competitive Landscape and Forecasts to 2031 - openPR - October 13th, 2022
- Cell & Tissue Preservation Market Size will Observe Lucrative Surge by the End 2031 - openPR - October 13th, 2022
- PRP and PRF in Cosmetics Market Growth Opportunities Analysis Report - openPR - October 13th, 2022
- Orthobiologics Market to Receive Overwhelming Hike in Revenues by 2031 - openPR - October 13th, 2022
- Stem Cells Market is Expected to Grow with High Probability Business Opportunity by 2028 - Digital Journal - October 4th, 2022
- External Beam Radiation Therapy Market: Growing Awareness about Early Detection and Diagnosis of various Cancer Types to Drive the Market - BioSpace - September 16th, 2022
- DiMethyl Sulfoxide (DMSO) Market to Touch US$ 838.6 Million in 2032 Owing to its Widespread Application in End-Use Industries & Anti-Inflammatory... - September 16th, 2022
- Virology Market Growth Prospects, Trends and Forecast up to 2030 - BioSpace - September 8th, 2022
- Cell Banking Outsourcing Market is Driven by Rising Number of Stem Cell Therapies across the Globe - BioSpace - September 8th, 2022
- Regenerative Therapies Market 2018 By Emerging Trends, Industry Share, Regional Overview and SWOT Analysis till 2026 - Digital Journal - August 22nd, 2022
- Autologous Stem Cell and Non-Stem Cell Based Therapies Market Trends, Competitive Landscape and Regional Insights to 2031 - BioSpace - August 14th, 2022
- Multiphoton Microscopy Market Insights, New Innovations, Research and Growth Factor till 2031 - BioSpace - August 14th, 2022
- Buffalo center fuels research that can save your life from heart disease and stroke - Buffalo News - August 5th, 2022
- Drug Discovery Services Market is Expected to Witness Significant Growth between 20212031 - BioSpace - July 27th, 2022
- Stem Cells Market to Expand at a CAGR of 10.4% from 2021 to 2028 Travel Adventure Cinema - Travel Adventure Cinema - July 27th, 2022
- Dental Membrane and Bone Graft Substitutes Market to Exceed Value of US$ 1,337 Mn by 2031 - PR Newswire UK - July 27th, 2022
- Lipid Disorder Treatment Market is Projected to Experience Promising Growth Opportunities in the Forthcoming Years - BioSpace - July 27th, 2022
- Immunoglobin Products Market to Witness Comprehensive Growth by 2031 - BioSpace - July 19th, 2022
- Antibody Therapy Market Propels at a Robust CAGR of 13.2% due to Rising Cancer and Other Chronic Disease Prevalence Future Market Insights, Inc. -... - July 19th, 2022
- Orthobiologics Market is Predicted to Expand at a CAGR of 4.7% during the Forecast Period, notes TMR Study - GlobeNewswire - July 11th, 2022
- Cell Line Development Market: Increase in Prevalence of Cancer and Other Chronic Diseases to Drive the Market - BioSpace - July 11th, 2022
- Transplant Diagnostic Market: Increase in Number of Cancer & Blood Disorder Patients to Drive the Market - BioSpace - July 11th, 2022
- Microscopy Devices Market Competitive Insights and Precise Outlook 2021-2028 Industrial IT - Industrial IT - June 4th, 2022
- Neoantigen Targeted Therapies Market Analysis and Opportunity Assessment up to 2027 - BioSpace - June 4th, 2022
- Why Eraser Enzymes Go Wrong and Lead to Cancer - SciTechDaily - December 10th, 2021
- MorphoSys and Incyte Announce the European Commission Approval of Minjuvi(R) (tafasitamab) in Combination with Lenalidomide for the Treatment of... - August 31st, 2021
- Incyte and MorphoSys Announce the European Commission Approval of Minjuvi (tafasitamab) in Combination With Lenalidomide for the Treatment of Adults... - August 31st, 2021
- Rock snot discovered in another Pennsylvania waterway - pennlive.com - September 12th, 2020
- Bone Marrow and Stem Cell Transplants ChristianaCare - June 20th, 2020
- 'Billion Dollar Burger' Asks: What Is Meat? - Delaware First Media - June 17th, 2020
- Data from Incytes Oncology Portfolio Accepted for Presentation at the ASCO and EHA Virtual Meetings - Yahoo Finance - May 20th, 2020
- Stem Cell therapy Middletown Delaware 19709 - February 10th, 2020
- First CAR-T cell cancer therapy patient in Delaware - Dover Post - February 10th, 2020
- Gore, Mayo Clinic team up to deliver breakthrough medical therapies - Plastics Today - December 17th, 2019
- Global Stem Cell Therapy Market 2019-2025 Analyzed by Business Growth, Development Factors, Applications, and Future Prospects - Technology Magazine - December 17th, 2019
- From inspiration to innovation | UDaily - UDaily - November 14th, 2019
- What Will Happen to Actinium Pharmaceuticals Inc (delaware (NYSEAMERICAN:ATNM) Next? The Stock Has Increase in Shorts - The Lamp News - October 26th, 2019
- Could Fate Therapeutics, Inc. (FATE) Recover After Forming a Bearish Head & Shoulders Pattern? - The Altcoin Mercury - September 25th, 2019
- Stem Cell therapy Lewes Delaware 19958 - September 14th, 2019
- Westfield High School Principal Derrick Nelson was 'gift ... - May 16th, 2019
- SignalRx - March 22nd, 2019
- Stem Cell therapy Newark Delaware 19725 - February 27th, 2019
- Stem Cell therapy Wilmington Delaware 19810 - February 27th, 2019
- Stem Cell Therapy | Regenerative Delaware - February 22nd, 2019
- Regenerative Cell Treatment &Therapy - Delaware ... - February 22nd, 2019
- Stem Cell Doctors Delaware, Stem cell injections, Stem ... - October 14th, 2018
- Regenerative Cell Therapy - Delaware Integrative Medicine - June 22nd, 2018
- Detroit Lions' Paul Worrilow has beaten odds, inspires others to help - Detroit Free Press - July 2nd, 2017
- Lions LB Paul Worrilow Making A Difference On And Off The Field - FanRag Sports (blog) - July 2nd, 2017
- Lions LB Paul Worrilow gave stem cells to anonymous leukemia patient - Detroit Free Press - March 11th, 2017
- Delaware (Stem Cell) - what-when-how - November 3rd, 2016
- University of Delaware Chemical Engineering - October 31st, 2015
- Home | www.papoutsakis.org - October 4th, 2015
- Stem Cells - Eppendorf - October 2nd, 2015
- Efficient Differentiation of Mouse Embryonic Stem Cells ... - October 1st, 2015
- Alpine Rose Leaf Extract for Environmental Protection for ... - October 1st, 2015
- De-Differentiation of Somatic Cells to a Pluripotent State ... - June 29th, 2015
- DSU AgDiscovery 2015 - Investing in the Future of American ... - June 1st, 2015
- Stem-cell battles: Stem-cell research in the USA is facing ... - April 9th, 2015
- IPS Stem Cells: New Ethical Quandaries - Santa Clara ... - December 27th, 2014
- The California Cloning and Stem Cell Laws - December 27th, 2014
- Can a bodys own stem cells help heal a heart? - October 19th, 2014
- Delaware Stem Cell Treatment | Stem Cell Treatments - September 9th, 2014
- Core mechanism for root growth identified - August 25th, 2014
- Stem Cell Companies - A Comprehensive Overview - August 23rd, 2014
- Stem Cell Doctors, Physician Team, Our Doctors - August 23rd, 2014
- California Stem Cell Report: California Stem Cell Agency ... - August 23rd, 2014
- Bone Marrow and Stem Cell Transplants - Christiana Care ... - August 22nd, 2014