Hundreds of clinics across the United States are marketing unapproved stem cell treatments for conditions ranging from aging skin to spinal cord injuries, a new study finds.
In an online search, researchers found at least 570 clinics offering unapproved stem cell "therapies." They tend to be concentrated in a handful of states -- including Arizona, California, Colorado, Florida, New York and Texas -- but are scattered across many other states, too.
Most often, the clinics market stem cell procedures for orthopedic conditions, such as arthritis and injured ligaments and tendons. This does have science behind it, but is still experimental, medical experts said.
In other cases with little or no supporting evidence, clinics hawked stem cell "facelifts" and therapies for serious conditions such as chronic lung disease, Parkinson's disease and multiple sclerosis.
If these pricey stem cell treatments are unproven and unapproved by federal regulators, how can these clinics exist?
"I ask myself that question all the time," said Leigh Turner, a bioethicist who worked on the study.
Turner, an associate professor at the University of Minnesota's Center for Bioethics, said attention used to focus on "stem cell tourism" -- where people travel to countries such as China, India and Mexico to get unproven treatments.
"I think there's a misperception that everything here [in the U.S.] is regulated," Turner said. "But these clinics are operating here, and on a relatively large scale."
Stem cells are primitive cells with the potential to mature into various types of body tissue. Medical researchers have been studying the possibility of using stem cells to repair damaged tissue in a range of chronic ills -- with limited success so far.
But the general public has heard about the "promise" of stem cells for years, and it can be easy to be taken in by clinics' marketing tactics, Turner said.
Websites can, for instance, link to published medical studies that make their therapies seem legitimate, Turner said. "These businesses can be quite savvy," he said. "I think it's asking too much to just tell consumers to be wary. We need to be asking, why should these clinics be allowed to do this?"
Arthur Caplan, a bioethicist who was not involved in the study, cited some explanations for the growth of stem cell clinics.
Play Video
In a breakthrough process, scientists are transforming stem cells into actual beating heart tissue. It could someday lead to new drug treatments ...
The businesses are usually not engaging in interstate commerce, which helps them "fly under the radar," said Caplan, who directs the division of medical ethics at NYU Langone Medical Center in New York City.
Plus, he said, there's a regulatory gray area when it comes to so-called "autologous" stem cell therapy -- which refers to treatments that use a person's own stem cells.
"If you have cells from your own body reinjected, it isn't clear that you're getting a 'new biologic,' " Caplan explained.
Of the businesses Turner's team found, most marketed autologous therapies, usually using stem cells from people's body fat or bone marrow. But about one-fifth of the businesses claimed to use stem cells from umbilical cord blood or amniotic or placental tissue.
The issue goes beyond people wasting their money or having their "hopes dashed," Turner said. It's known some have been seriously harmed.
He mentioned two elderly patients in Florida who died following an unapproved stem cell procedure.
The U.S. Food and Drug Administration has taken steps against specific businesses. Last year, it sent a warning letter to a network of clinics that operate in California, Florida and New York. According to the FDA, the clinics illegally use stem cells from people's fat tissue to treat conditions such as Parkinson's, MS, amyotrophic lateral sclerosis (ALS) and autism.
"Many of these claims are outrageous," Caplan said. "These clinics are preying on vulnerable people."
His advice for consumers: "Be wary of any procedure that comes with celebrity endorsements or patient testimonials."
The FDA has issued draft guidelines on the use of stem cells. A public hearing is scheduled for later this year.
The new study findings appear in the June 30 issue of Cell Stem Cell.
See the original post here:
Hundreds of U.S. clinics are selling unapproved stem cell ...
- Stem Cell Clinics List | Stem Cells Freak [Last Updated On: May 30th, 2015] [Originally Added On: May 30th, 2015]
- Stem Cell Therapy Clinics In Canada | Stem Cell Medical ... [Last Updated On: August 2nd, 2015] [Originally Added On: August 2nd, 2015]
- Predatory stem cell clinics are winning the war; what can ... [Last Updated On: September 22nd, 2015] [Originally Added On: September 22nd, 2015]
- Stem cell clinics, FDA, and giant, unapproved for-profit ... [Last Updated On: September 25th, 2015] [Originally Added On: September 25th, 2015]
- Adult Stem Cell Banks and Clinics Marketing Stem Cell ... [Last Updated On: September 25th, 2015] [Originally Added On: September 25th, 2015]
- Stem Cell Clinics : National Multiple Sclerosis Society [Last Updated On: September 29th, 2015] [Originally Added On: September 29th, 2015]
- First stem cell treatment for human administered in Atlanta ... [Last Updated On: August 20th, 2016] [Originally Added On: August 20th, 2016]
- Treatment Abroad | Canadian Stem Cell Foundation [Last Updated On: September 18th, 2016] [Originally Added On: September 18th, 2016]
- CIRM Alpha Stem Cell Clinic - UCSD Stem Cell Program [Last Updated On: September 18th, 2016] [Originally Added On: September 18th, 2016]
- Stem Cell Clinics Questions to Ask - National Multiple ... [Last Updated On: September 23rd, 2016] [Originally Added On: September 23rd, 2016]
- Stem Cell Therapy - Cendant Cellular Therapies - Denver ... [Last Updated On: November 30th, 2016] [Originally Added On: November 30th, 2016]
- Private clinics' peddling of unproven stem cell treatments is unsafe and unethical - Medical Xpress [Last Updated On: July 8th, 2017] [Originally Added On: July 8th, 2017]
- North Central Texas Stem Cell Clinics in conjunction ... [Last Updated On: July 9th, 2017] [Originally Added On: July 9th, 2017]
- Broomfield's Regenexx in merger with Iowa company - Longmont Times-Call [Last Updated On: July 12th, 2017] [Originally Added On: July 12th, 2017]
- Dozens of US clinics sell unproven stem cell therapies for heart failure - Fox News [Last Updated On: July 30th, 2017] [Originally Added On: July 30th, 2017]
- Stem cell treatment potential in Canada - IMTJ [Last Updated On: August 20th, 2017] [Originally Added On: August 20th, 2017]
- FDA cracks on clinics using unapproved stem cell treatments - Pulse Headlines [Last Updated On: August 29th, 2017] [Originally Added On: August 29th, 2017]
- FDA cracks down on clinics selling unapproved stem cell therapies - CBS News [Last Updated On: August 29th, 2017] [Originally Added On: August 29th, 2017]
- FDA to crack down on 'unscrupulous' stem cell clinics ... [Last Updated On: August 31st, 2017] [Originally Added On: August 31st, 2017]
- FDA cracks down on clinics selling unproven stem cell therapies - Gears Of Biz [Last Updated On: September 3rd, 2017] [Originally Added On: September 3rd, 2017]
- Canadian clinics begin offering stem-cell treatments ... [Last Updated On: September 3rd, 2017] [Originally Added On: September 3rd, 2017]
- Stem Cell Therapy and Its Revolutionary Purposes Guardian ... - Guardian Liberty Voice [Last Updated On: September 4th, 2017] [Originally Added On: September 4th, 2017]
- At ClinicalTrials.Gov, Untested Stem Cell Clinics ... [Last Updated On: October 13th, 2017] [Originally Added On: October 13th, 2017]
- Adult Stem Cell Therapy in Utah Docere Clinics [Last Updated On: October 18th, 2017] [Originally Added On: October 18th, 2017]
- Patients guide to treatments - The Niche [Last Updated On: July 14th, 2018] [Originally Added On: July 14th, 2018]
- FDA: Florida Stem Cell Clinic Violates Law | Health News Florida [Last Updated On: September 15th, 2018] [Originally Added On: September 15th, 2018]
- Stem cell laws - Wikipedia [Last Updated On: October 17th, 2018] [Originally Added On: October 17th, 2018]
- What Stem Cell Clinics Do You Trust? | BioInformant [Last Updated On: November 5th, 2018] [Originally Added On: November 5th, 2018]
- Meet Our Doctors - Rejuva Stem Cell Clinic [Last Updated On: December 24th, 2018] [Originally Added On: December 24th, 2018]
- FDA Wants To Tighten The Screws On Stem Cell Clinics ... [Last Updated On: December 24th, 2018] [Originally Added On: December 24th, 2018]
- Stem cell market: Inside California's flourishing for ... [Last Updated On: December 24th, 2018] [Originally Added On: December 24th, 2018]
- Stem cell therapy: FDA investigates clinics offering ... [Last Updated On: January 11th, 2019] [Originally Added On: January 11th, 2019]
- Stem Cell Therapy Chicago Illinois, Buffalo Grove ... [Last Updated On: January 23rd, 2019] [Originally Added On: January 23rd, 2019]
- Stem Cell Transplant in Germany: Clinics, Cost, Price ... [Last Updated On: February 15th, 2019] [Originally Added On: February 15th, 2019]
- Mayo Clinic finds surprising results on first-ever test of ... [Last Updated On: February 15th, 2019] [Originally Added On: February 15th, 2019]
- Stem Cell Clinics - eureka [Last Updated On: February 15th, 2019] [Originally Added On: February 15th, 2019]
- Patients fleeced by overseas stem cell clinics? Now it ... [Last Updated On: April 1st, 2019] [Originally Added On: April 1st, 2019]
- Stem cell clinics sued | Regenerative Medicine Foundation [Last Updated On: April 1st, 2019] [Originally Added On: April 1st, 2019]
- UCLA UCI Alpha Stem Cell Clinic | UCLA Broad Stem Cell Center [Last Updated On: April 1st, 2019] [Originally Added On: April 1st, 2019]
- Stem cell clinics make big claims but offer little ... [Last Updated On: April 1st, 2019] [Originally Added On: April 1st, 2019]
- Private clinics peddling of unproven stem cell treatments ... [Last Updated On: April 29th, 2019] [Originally Added On: April 29th, 2019]
- FDA Mounts Aggressive Push to Regulate Stem-Cell Clinics ... [Last Updated On: May 16th, 2019] [Originally Added On: May 16th, 2019]
- 'Stem cell' therapies offered at private clinics need to ... [Last Updated On: May 22nd, 2019] [Originally Added On: May 22nd, 2019]
- Amyotrophic Lateral Sclerosis (Lou Gehrigs Disease) Treatment Market Size, Status and Growth Opportunities by 2016 2022 - Analytics News [Last Updated On: September 24th, 2019] [Originally Added On: September 24th, 2019]
- Global Stem Cell Cartilage Regeneration Market Size, Development Plans and Forecast to 2028 - Analytics News [Last Updated On: September 24th, 2019] [Originally Added On: September 24th, 2019]
- Global Canine Stem Cell Therapy Market Data Analysis, Growth, Demand & Forecast 2019-2024: VETSTEM BIOPHARMA, Cell Therapy Sciences, Regeneus,... [Last Updated On: September 24th, 2019] [Originally Added On: September 24th, 2019]
- Opinion: Kudos to Google for banning stem cell ads. Other tech companies should follow - Yahoo News [Last Updated On: September 24th, 2019] [Originally Added On: September 24th, 2019]
- Google banned ads for stem cell treatments. Others should follow - STAT [Last Updated On: September 24th, 2019] [Originally Added On: September 24th, 2019]
- Better solutions for the replacement of joints - SciTech Europa [Last Updated On: September 28th, 2019] [Originally Added On: September 28th, 2019]
- Tech review: Apps that enhance cellphone battery performance - Newsday [Last Updated On: October 10th, 2019] [Originally Added On: October 10th, 2019]
- BEYOND LOCAL: Expert recommends 'path of cautious optimism' about the future of stem cell treatment - NewmarketToday.ca [Last Updated On: October 10th, 2019] [Originally Added On: October 10th, 2019]
- BEYOND LOCAL: Expert recommends 'path of cautious optimism' about the future of stem cell treatment - CollingwoodToday [Last Updated On: October 12th, 2019] [Originally Added On: October 12th, 2019]
- Business briefs - News - The Hutchinson News [Last Updated On: November 3rd, 2019] [Originally Added On: November 3rd, 2019]
- Canine Arthritis Treatment Market 2018 to Showing Impressive Growth by 2027 | Industry Trends, Share, Size, Top Key Players Analysis and Forecast... [Last Updated On: November 12th, 2019] [Originally Added On: November 12th, 2019]
- Global cell therapy market is expected to grow with a healthy CAGR over the forecast period from 2019-2025 - PRNewswire [Last Updated On: November 12th, 2019] [Originally Added On: November 12th, 2019]
- Stem of the problem | Columns | Journal Gazette - Fort Wayne Journal Gazette [Last Updated On: December 3rd, 2019] [Originally Added On: December 3rd, 2019]
- Examining the ethics of embryonic stem cell research ... [Last Updated On: December 3rd, 2019] [Originally Added On: December 3rd, 2019]
- Must-Reads Of The Week From Brianna Labuskes - Kaiser Health News [Last Updated On: December 6th, 2019] [Originally Added On: December 6th, 2019]
- Bioethics experts call on GoFundMe to ban unproven medical treatments - The Verge [Last Updated On: December 10th, 2019] [Originally Added On: December 10th, 2019]
- Automation in Cell Therapy Manufacturing Is Driving the Growth of the Cell Therapy Market over the Forecast Period (2019-2025) - Press Release -... [Last Updated On: December 14th, 2019] [Originally Added On: December 14th, 2019]
- Drugs, Biologics, and Regenerative Medicine in 2019: A Successful Year Ends with Promise of a More Challenging 2020 - JD Supra [Last Updated On: December 18th, 2019] [Originally Added On: December 18th, 2019]
- Where Are They Now? Top 3 Biotech Startups From NextGen Bio Class of 2018 - BioSpace [Last Updated On: January 7th, 2020] [Originally Added On: January 7th, 2020]
- Orthobiology Market Innovative Technologies, Current And Future Trends - PharmiWeb.com [Last Updated On: January 15th, 2020] [Originally Added On: January 15th, 2020]
- Why stem cells could be the medical innovation of the century - World Economic Forum [Last Updated On: January 17th, 2020] [Originally Added On: January 17th, 2020]
- Europe's guardian of stem cells and hopes, real and unrealistic - Yahoo News [Last Updated On: January 25th, 2020] [Originally Added On: January 25th, 2020]
- Stem cell clinics much-hyped treatments lack scientific support - Science News [Last Updated On: January 31st, 2020] [Originally Added On: January 31st, 2020]
- Mystery of Leaky Gut Plumbed by UCSD Team, Which Created Mini-Guts - Times of San Diego [Last Updated On: February 11th, 2020] [Originally Added On: February 11th, 2020]
- Health: Is this company onto an alternative to stem cell therapy? - Stockhead [Last Updated On: February 12th, 2020] [Originally Added On: February 12th, 2020]
- Canine Stem Cell Therapy Market Recent Trends, In-depth Analysis, Size and Forecast To 2027 | VETSTEM BIOPHARMA, Cell Therapy Sciences, Regeneus,... [Last Updated On: February 15th, 2020] [Originally Added On: February 15th, 2020]
- 10 Best Clinics for Stem Cell Therapy in Mexico [2020 Prices] [Last Updated On: February 15th, 2020] [Originally Added On: February 15th, 2020]
- Advice on Finding Legitimate Stem Cell Clinics - CBS News [Last Updated On: February 15th, 2020] [Originally Added On: February 15th, 2020]
- Global Skin and Wound Care Market Is Expected to Reach USD 25.98 Billion by 2025 : Fior Markets - Yahoo Finance [Last Updated On: March 4th, 2020] [Originally Added On: March 4th, 2020]
- Dubai is the 'new Beverly Hills of the Middle East': Here's why - Gulf News [Last Updated On: March 7th, 2020] [Originally Added On: March 7th, 2020]
- Best Market Research on Stem Cell Therapy Market, Industry / Sector Analysis Report, Regional Outlook & Competitive Market Share & Forecast,... [Last Updated On: March 9th, 2020] [Originally Added On: March 9th, 2020]
- Amyotrophic Lateral Sclerosis Treatment Market Share Forecast to 2027: Orion Pharma, Kringle Pharma, Inc., Aquestive Therapeutics, Apotex Inc, Bausch... [Last Updated On: March 11th, 2020] [Originally Added On: March 11th, 2020]
- Future Growth Of Animal Stem Cell Therapy Market By New Business Developments - News by aeresearch [Last Updated On: March 17th, 2020] [Originally Added On: March 17th, 2020]
- Global transcutaneous electrical nerve stimulation market is expected to grow with a healthy CAGR over the forecast period from 2019-2025 - PRNewswire [Last Updated On: March 24th, 2020] [Originally Added On: March 24th, 2020]
- Stem Cell Therapy Market is expected to reach US$ 5129.66 million in 2027 - Germany English News [Last Updated On: April 6th, 2020] [Originally Added On: April 6th, 2020]
- Stem Cell Therapy Market to 2027 - Global Analysis and Forecasts by Type; Treatment; Application; End User, and Geography - Baker City Herald [Last Updated On: April 18th, 2020] [Originally Added On: April 18th, 2020]
- Stem Cell Therapy Market to 2027 - Global Analysis and Forecasts by Type; Treatment; Application; End User, and Geography - P&T Community [Last Updated On: April 19th, 2020] [Originally Added On: April 19th, 2020]