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 - Hawaii Public Radio-HPR2
- Is There Enough Phosphorus for Us? - Discovery Institute - September 8th, 2022
- Types of Tissues Anatomy & Physiology - University of Hawaii - August 22nd, 2022
- Structure and Function - Fish | manoa.hawaii.edu/ExploringOurFluidEarth - August 14th, 2022
- Hotels are offering guests $12,000 stem cell therapies, chewing lessons, and IV drips in luxury wellness kick - Business Insider Africa - July 3rd, 2022
- A major science fair set these scientists on the path to STEM success - Science News for Students - May 15th, 2022
- Immune System: Diseases, Disorders & Function - Live Science - April 19th, 2022
- CellOrigin secured a new round of investment for developing its globally proprietary iPSC-CAR-Macrophage technology platform - Hawaii News Now - October 16th, 2021
- BrainStorm to Present at the 2021 Cell & Gene Meeting on the Mesa - Hawaii News Now - October 5th, 2021
- Marine Biologists Are Using Cryopreservation to Save the World's Coral Reefs - Hawaiipublicradio - July 21st, 2021
- Woman Who Was Attacked By Cat Sues the Outrigger Canoe Club in Waikiki - Legal Reader - November 7th, 2019
- Stemming the Tide of Alzheimer's - UCI News - October 9th, 2019
- 20 Strangest Scientific Discoveries Of The Last 20 Years - TheTalko - October 9th, 2019
- CaverStem on the Big Island Giveaway! - EDGEOnTheNet - October 2nd, 2019
- Contact Us - Stem Cell Treatment Center Hawaii - May 14th, 2019
- Stem Cells and Sports Injuries - Honolulu Hawaii - September 5th, 2018
- MushRoaming Hawaii | Mushroaming - Daniel Winkler's ... - June 27th, 2018
- Yeargan Uses Patients Own Cells To Heal - Greater Wilmington Business Journal - August 27th, 2017
- Pan Pacific Surgical Hawaii Plastic Surgery Symposium - November 27th, 2016
- Cord Blood Banking Cost - Cryo-Cell International - November 25th, 2016
- Stem Cell Therapy - Honolulu Hawaii - Infinity Life Center - November 20th, 2016
- Stem Cell Therapy - Honolulu Hawaii - infinitylifecenter.com - November 18th, 2016
- Stem Cell Treatment Center Hawaii - Stem Cell Treatment ... - September 21st, 2016
- Orthopedic Stem Cell Treatments - Orthopedics - Stem Cell ... - September 15th, 2016
- 6. Hematopoietic Stem Cell ... - University of Hawaii - August 29th, 2016
- Regenexx injections - Stem Cells - The KNEEguru - August 14th, 2016
- Hawaii Stem Cell Treatment Center | Facebook - August 10th, 2016
- Adipose-Derived Mesenchymal Stem Cells; Normal ... - ATCC - October 19th, 2015
- Animal Cells - An educational website all about animal cells - October 1st, 2015
- ASC52telo, hTERT immortalized adipose derived Mesenchymal ... - October 1st, 2015
- How Much Do Stem Cell Treatments Really Cost? | Knoepfler ... - August 9th, 2015
- New Stem Cell Tactic Shows Promise for Heart Failure - August 1st, 2015
- Global Stem Cells Group to Participate in the 15th ... - June 18th, 2015
- Industrial Technology Research Institute Validates ... - June 11th, 2015
- Global Stem Cells Group and Marina Medical Announce ... - June 4th, 2015
- Maui Regenerative Medicine - June 3rd, 2015
- Stem Cell Training, Inc. Announces First European ... - June 1st, 2015
- A Catholic View on Stem-Cell Research - Catholicism and ... - March 13th, 2015
- PowerPoint Presentation - February 23rd, 2015
- Types of Stem Cells - Biology Slideshow - Biology ... - February 2nd, 2015
- Stem Cell Treatment Center Hawaii - Help - Stem Cell ... - October 21st, 2014
- Stem Cell Treatment Center Hawaii - Rules - Stem Cell ... - October 13th, 2014
- Human Cloning and Stem Cells - University of Hawaii - October 3rd, 2014
- Stem Cell Research - Stem Cells and Medicine ... - October 3rd, 2014
- Hawaii (Stem Cell) - what-when-how - August 26th, 2014
- Adult stem cell - Wikipedia, the free encyclopedia - August 23rd, 2014
- Pros & Cons of Embryonic Stem Cell Research - US Liberal ... - August 23rd, 2014
- Stem Cell Therapy Hawaii | Stem Cell Treatments - August 22nd, 2014
- Stem cell treatment gives Honolulu dog better life | More ... - August 22nd, 2014