On Monday, the U.S. Food and Drug Administration (FDA) announced that the agency is targeting clinics that offer unproven stem cell therapies, calling such offices "unscrupulous clinics" selling "so-called cures." The FDA seized materials from one clinic in California, and sent a warning letter to another in Florida.
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," said FDA Commissioner Dr. Scott Gottlieb in a statement.
The agency announced that on Friday, Aug. 25th, U.S. Marshals seized five vials of a vaccine that is intended for people at a high risk for smallpox (for example, people in the military) from StemImmune Inc. in San Diego, California. The FDA says it learned that StemImmune was using the vaccines as well as stem cells from body fat to create an unapproved stem cell therapy. On its website, StemImmune says "The patients own (autologous, adult) stem cells, armed with potent anti-cancer payloads, function like a Trojan Horse, homing to tumors and cancer cells, undetected by the immune system." The stem cell treatment was injected into the tumors of cancer patients at the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, California.
MORE: Three People Are Nearly Blind After Getting a Stem Cell Treatment
The FDA also sent a warning later to U.S. Stem Cell Clinic in Sunrise, Florida. The company recently came under public scrutiny when a March report revealed that three people had severe damage to their vision one woman went blindafter they were given shots of what the company said were stem cells into their eyes during a study sponsored by the clinic. The FDA says that an inspection of U.S. Stem Cell Clinic revealed that the clinic was using stem cells to treat diseases like Parkinson's, amyotrophic lateral sclerosis (ALS), chronic obstructive pulmonary disease (COPD), heart disease and pulmonary fibrosis. According to the FDA, there are currently only a limited number of stem cell therapies approved by the agencyincluding ones involving bone marrow, for bone marrow transplants in cancer care, and cord blood for specific blood-related disorders. There are no approved stem cell treatments for other diseases.
The FDA says U.S. Stem Cell Clinic also attempted to interfere with the FDA's most recent inspection by refusing to allow FDA investigators to enter without an appointment, and denied the agency access to its employees. "Refusing to permit entry or FDA inspection is a violation of federal law," the FDA says.
Action by the FDA on clinics promoting unproven stem cell therapies is "a long time coming," says Sean Morrison, former president of the International Society for Stem Cell Research (ISSCR) and d irector of the Childrens Research Institute at UT Southwestern. "C linics are preying on the hopes of desperate patients claiming they can cure all manner of diseases with stem cells that have not been tested in clinical trials, and in some cases, are flat out impossible."
In the past, medical experts were concerned over Americans traveling to countries with less medical regulation for stem cell therapies, but Morrison says such clinics have been popping up stateside over the last five years. "It's not a few companies in the U.S. making claims about therapies with stem cells," says Morrison. "It's scores of companies. The problem has exploded in the U.S."
Morrison blames the lack of FDA crackdown in the past for the growing problem. "At some point people made the calculation that the FDA didnt seem to be enforcing these laws," he says. "The margins are huge. They charge people tens of thousands of dollars."
Since stem cell therapy is still an active and legitimate area of scientific research, it can be hard for Americans to figure out what is safe and effective and what is not. Even when it comes to clinical trials, the scientific soundness is murky. A July 2017 paper reported that 18 U.S. companies have registered "patient-sponsored" stem cell studies on ClinicalTrials.gov. That means that the patients receiving the treatment paid for them, which isn't the case in more legitimate studies. None of these were gold standard studies: meaning the people were not randomly assigned to receive the treatment or not, so the participants knew they were receiving the therapy that could bias the results. Only seven of the studies disclosed upfront that patients had to pay to join the study, and none revealed that the costs ranged from $5,000 to $15,000 a treatment, Wired reports.
While Morrison says he's glad the FDA has taken action, he says it's not enoughat least not yet. "The FDA has to show that there is really a sustained commitment to enforcement," he says. "When the FDA wasnt bringing actions against these companies, I think people thought this meant that it was a gray area and that they could get away with it."
Undoing that damage could be a long process, and one that Morrison says needs consistent attention by the agency. In a letter released on Monday, FDA commissioner Gottlieb said the agency is stepping up enforcement of stem cell therapies and regenerative medicine. "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," said Gottlieb. Whether those efforts have an impact remains to be seen.
Read the original here:
FDA Cracks Down on Stem Cell Clinics But Patients Are Still at Risk - TIME
- Stem Cell Therapy for Kidney Failure [Last Updated On: April 1st, 2011] [Originally Added On: April 1st, 2011]
- Dogged by pain -- stem cell therapy for dogs [Last Updated On: June 24th, 2013] [Originally Added On: April 3rd, 2011]
- Dogs now getting stem cell therapy [Last Updated On: April 8th, 2011] [Originally Added On: April 8th, 2011]
- Stem Cells for Spinal Cord Injury: Community Outreach San Diego 2011 - Trish Stressman [Last Updated On: April 11th, 2011] [Originally Added On: April 11th, 2011]
- Stem Cell Treatment Doing Wonders For Autistic Boy [Last Updated On: April 14th, 2011] [Originally Added On: April 14th, 2011]
- Is Stem Cell Therapy right for your pet [Last Updated On: April 14th, 2011] [Originally Added On: April 14th, 2011]
- Regenerative Medicines [Last Updated On: May 19th, 2011] [Originally Added On: May 19th, 2011]
- Stem Cell Therapy for Multiple Sclerosis [Last Updated On: June 24th, 2013] [Originally Added On: May 20th, 2011]
- Adult Stem Cell Therapy for Multiple Sclerosis [Last Updated On: May 23rd, 2011] [Originally Added On: May 23rd, 2011]
- Heart Failure Patient After Adult Stem Cell Therapy [Last Updated On: June 24th, 2013] [Originally Added On: May 30th, 2011]
- Stem Cell Therapy For Alzheimer's/Dementia [Last Updated On: June 24th, 2013] [Originally Added On: June 2nd, 2011]
- Stem Cell Therapy For Alzheimer's/Dementia [Last Updated On: June 7th, 2011] [Originally Added On: June 7th, 2011]
- Stem Cell Therapy Injections [Last Updated On: June 24th, 2013] [Originally Added On: June 8th, 2011]
- Clinical Advances in Adult Stem Cell Therapy: Dr. Jorge Paz [Last Updated On: June 24th, 2013] [Originally Added On: June 11th, 2011]
- Stem Cell Therapy MS: Sam Harrell and The Superbowl [Last Updated On: June 12th, 2011] [Originally Added On: June 12th, 2011]
- Stem Cell Therapy MS: Sam Harrell and The Superbowl [Last Updated On: June 24th, 2013] [Originally Added On: June 14th, 2011]
- Lou Gehrig's Disease (ALS): UCSD Team's Stem Cell Therapy Rationale [Last Updated On: June 14th, 2011] [Originally Added On: June 14th, 2011]
- Stem Cell Injection Treatment - Stem Cell Therapy [Last Updated On: June 18th, 2011] [Originally Added On: June 18th, 2011]
- edivet America Dog Arthritis Stem Cell Therapy Stem Cell Therapy for Equine 1 [Last Updated On: June 24th, 2013] [Originally Added On: June 23rd, 2011]
- Lou Gehrig's Disease (ALS): UCSD Team's Stem Cell Therapy Approach [Last Updated On: June 25th, 2011] [Originally Added On: June 25th, 2011]
- Adult Stem Cell Therapy Clinical Advances - Dr. Jorge Paz in San Diego, CA March 2011 [Last Updated On: July 3rd, 2011] [Originally Added On: July 3rd, 2011]
- Adult Stem Cell Therapy Clinical Advances - Dr. Jorge Paz in San Diego, CA March 2011 [Last Updated On: June 24th, 2013] [Originally Added On: July 15th, 2011]
- Duffy Gets Stem Cell Therapy [Last Updated On: June 24th, 2013] [Originally Added On: July 15th, 2011]
- WAVE3 News Adipose Stem Cell Therapy [Last Updated On: June 24th, 2013] [Originally Added On: July 16th, 2011]
- Lou Gehrig's Disease (ALS): UCSD Team's Stem Cell Therapy Approach [Last Updated On: June 24th, 2013] [Originally Added On: July 16th, 2011]
- Clinical Advances in Adult Stem Cell Therapy - Dr. Jorge Paz Rodriguez (Miami) [Last Updated On: June 24th, 2013] [Originally Added On: July 21st, 2011]
- Stem Cell Therapy for Cerebral Palsy - Holly Catalano [Last Updated On: June 24th, 2013] [Originally Added On: August 2nd, 2011]
- Bone Marrow Aspiration - Stem Cell Therapy [Last Updated On: August 5th, 2011] [Originally Added On: August 5th, 2011]
- Dr. Chein discusses Autologous Stem Cell Therapy - Palm Springs [Last Updated On: June 24th, 2013] [Originally Added On: August 12th, 2011]
- Stroke Victim Improved With Stem Cell Therapy. More at http://www.stemcellfusion.com [Last Updated On: June 24th, 2013] [Originally Added On: August 14th, 2011]
- Dr. Craig Saunders Adult Stem Cell Therapy [Last Updated On: August 15th, 2011] [Originally Added On: August 15th, 2011]
- Embryonic stem cell therapy in China (www.esctherapy.com) [Last Updated On: June 24th, 2013] [Originally Added On: August 16th, 2011]
- Ying Liu discusses IPS cell therapy for ALS [Last Updated On: June 24th, 2013] [Originally Added On: August 16th, 2011]
- Stem Cell Therapy: Healing Force of the future [Last Updated On: September 19th, 2011] [Originally Added On: September 19th, 2011]
- Benefits of STEM CELL THERAPY - Adipose Tissue [Last Updated On: September 22nd, 2011] [Originally Added On: September 22nd, 2011]
- Stem Cell Therapy Skin Repair and Anti-Wrinkle Cream [Last Updated On: June 24th, 2013] [Originally Added On: September 24th, 2011]
- Cardiac Stem Cell Therapy [Last Updated On: June 24th, 2013] [Originally Added On: September 24th, 2011]
- Holly Huber on Recovery: Stem Cell Therapy for Multiple Sclerosis Community Outreach Dallas, TX 2011 [Last Updated On: June 24th, 2013] [Originally Added On: September 24th, 2011]
- Stroke Victim Improved With Stem Cell Therapy. More at http://www.stemcellfusion.com [Last Updated On: September 25th, 2011] [Originally Added On: September 25th, 2011]
- A Touch of Love® - Stem Cell Therapy for Pets-Dr. Danny DeRose-Part 3 [Last Updated On: September 27th, 2011] [Originally Added On: September 27th, 2011]
- Adult Stem Cell Therapy for Multiple Sclerosis [Last Updated On: June 24th, 2013] [Originally Added On: September 28th, 2011]
- Multiple Sclerosis Stem Cell Therapy News Coverage [Last Updated On: June 24th, 2013] [Originally Added On: October 1st, 2011]
- The Spinal Cord Journey - Stem cell therapy stories from three spinal cord injury patients [Last Updated On: October 6th, 2011] [Originally Added On: October 6th, 2011]
- Peyton Manning Stem Cell Therapy: Some Doctors Cry Foul Over European Treatment - Video [Last Updated On: October 13th, 2011] [Originally Added On: October 13th, 2011]
- Stem-Cell-Therapy-in-China.wmv - Video [Last Updated On: October 13th, 2011] [Originally Added On: October 13th, 2011]
- Randolph veterinarian uses new stem cell therapy on ailing pets - Video [Last Updated On: June 24th, 2013] [Originally Added On: October 13th, 2011]
- Stem Cell Therapy for Rheumatoid Arthritis - Video [Last Updated On: June 24th, 2013] [Originally Added On: October 14th, 2011]
- Holly Huber on Recovery: Stem Cell Therapy for Multiple Sclerosis Community Outreach Dallas, TX 2011 - Video [Last Updated On: October 14th, 2011] [Originally Added On: October 14th, 2011]
- Affordable Stem Cell Therapy in Guatemala (2hrs from Miami) - Video [Last Updated On: June 24th, 2013] [Originally Added On: October 15th, 2011]
- Stem Cell Research: Macular Degeneration - Video [Last Updated On: October 18th, 2011] [Originally Added On: October 18th, 2011]
- Duffy Gets Stem Cell Therapy - Video [Last Updated On: October 18th, 2011] [Originally Added On: October 18th, 2011]
- VetCell's StemRegen - the original and best stem cell therapy for equine tendon injuries - Video [Last Updated On: October 20th, 2011] [Originally Added On: October 20th, 2011]
- Macular degeneration - Stem Cell therapy (English subtitles) - Video [Last Updated On: October 20th, 2011] [Originally Added On: October 20th, 2011]
- Stem Cell Therapy for Rheumatoid Arthritis - Community Outreach Dallas - Darnell Morris - Video [Last Updated On: June 24th, 2013] [Originally Added On: October 21st, 2011]
- Adult Stem Cell Therapy for Congestive Heart Failure [Last Updated On: June 24th, 2013] [Originally Added On: October 21st, 2011]
- Stem Cell Therapy for Critical Limb Ischemia: First Choice or Last Ditch? - Video [Last Updated On: October 22nd, 2011] [Originally Added On: October 22nd, 2011]
- WAVE3News Adipose Stem Cell Therapy - Video [Last Updated On: October 22nd, 2011] [Originally Added On: October 22nd, 2011]
- Stem Cell Therapy in Cardiac Disease - Video [Last Updated On: June 24th, 2013] [Originally Added On: October 24th, 2011]
- Stem Cell Treatment for Autism: Community Outreach Miami, Florida - May 2011 - Video [Last Updated On: June 24th, 2013] [Originally Added On: October 24th, 2011]
- Pre Post n 6 Months Post Stem Cell Therapy of Dystonic Cerebral Palsy - Video [Last Updated On: June 24th, 2013] [Originally Added On: October 24th, 2011]
- Stem Cell Treatment for Rheumatoid Arthritis - "I am basically pain free." - Video [Last Updated On: October 26th, 2011] [Originally Added On: October 26th, 2011]
- UMBILICAL CORD STEM CELL THERAPY - Video [Last Updated On: June 24th, 2013] [Originally Added On: October 26th, 2011]
- Stem Cell Therapy for Peripheral Artery Disease - Video [Last Updated On: June 24th, 2013] [Originally Added On: October 26th, 2011]
- Multiple Sclerosis Adult Stem Cell Therapy - Video [Last Updated On: June 24th, 2013] [Originally Added On: October 26th, 2011]
- Stem Cell Therapy for Multiple Sclerosis Stimulates IDO - Video [Last Updated On: June 24th, 2013] [Originally Added On: October 26th, 2011]
- HIV/AIDS: Spotlight on Stem Cell Research - John Zaia - Video [Last Updated On: October 26th, 2011] [Originally Added On: October 26th, 2011]
- Stem cell treatment by Adiva Health Care India after Spinal Cord Injury - Video [Last Updated On: October 27th, 2011] [Originally Added On: October 27th, 2011]
- Stem Cell Treatment for Spinal Cord Injury - Video [Last Updated On: October 28th, 2011] [Originally Added On: October 28th, 2011]
- Lou Gehrig's Disease: Stem Cell Therapy Pre-Clinical Studies - Video [Last Updated On: October 28th, 2011] [Originally Added On: October 28th, 2011]
- Stem Cell Treatment for Spinal Cord Injury - Video [Last Updated On: June 24th, 2013] [Originally Added On: October 28th, 2011]
- Holly Huber on Recovery: Stem Cell Therapy for Multiple Sclerosis Community Outreach San Diego CA - Video [Last Updated On: June 24th, 2013] [Originally Added On: October 28th, 2011]
- Stem Cell Treatment for Rheumatoid Arthritis - "I got my life back" - Video [Last Updated On: October 28th, 2011] [Originally Added On: October 28th, 2011]
- Adult Stem Cell Therapy Following Heart Attack and Stroke - Video [Last Updated On: October 28th, 2011] [Originally Added On: October 28th, 2011]
- Stem Cells - Treatment for Autism - Video [Last Updated On: November 2nd, 2011] [Originally Added On: November 2nd, 2011]
- Stem Cell Treatment Diabetes - Video [Last Updated On: November 7th, 2011] [Originally Added On: November 7th, 2011]
- Stem Cell Therapy: Psoriatic Arthritis Treatment - Video [Last Updated On: June 24th, 2013] [Originally Added On: November 8th, 2011]
- Stem Cell Therapy Cure Hair Loss. More at http://www.stemcellfusion.com - Video [Last Updated On: June 24th, 2013] [Originally Added On: November 10th, 2011]
- BioLogic Stem Cell Therapy - Video [Last Updated On: November 16th, 2011] [Originally Added On: November 16th, 2011]
- BioLogic Stem Cell Therapy - Video [Last Updated On: June 24th, 2013] [Originally Added On: November 16th, 2011]
- AVS Stem Cell Therapy - Video [Last Updated On: June 24th, 2013] [Originally Added On: November 17th, 2011]