A South Florida clinic that promotes controversial stem-cell treatments for a wide range of ailments is among the centers receiving a written warning that it is violating federal public health laws.
The U.S Food and Drug Administrations letter was addressed to Dr. Thomas A. Gionis, owner and chief surgeon of the Miami Stem Cell Treatment Center located in Boca Raton. Gionis also owns a stem cell treatment center in Irvine, Calif.
The letter shows that a third Gionis clinic in New York City apparently closed after FDA inspections of all three clinics was carried out from July through September 2015.
Dr. Gionis facilities are among more than 170 clinics across the country that are selling experimental stem cell procedures for dozens of diseases and conditions a mushrooming industry that has flourished despite little evidence of its safety or effectiveness.
Descriptions on the website say that Dr. Gionis and other practitioners inject or infuse a liquid that is said to contain stem cells derived from the patients own fat tissue, removed through liposuction. The clinic lists a large number of illnesses for which it says the treatments are appropriate, including: heart and lung disease, stroke, multiple sclerosis, spinal disc disease and auto-immune problems like lupus.
And his clinics are not the only ones operating in Florida. Internet search indicates this type of stem-cell treatment is available at clinics in Jacksonville, Orlando, St. Petersburg, Sunrise and a number of other sites throughout the state.
The rise of the U.S. stem cell industry illustrates how quickly fringe medicine can outpace government oversight. Over the last five years, academic stem cell researchers say they have watched in dismay as doctors treat patients with experimental techniques that they say could take years, if not decades, to become sound medicine.
"It's sort of this 21st century cutting-edge technology. But the way it's being implemented at these clinics and how it's regulated is more like the 19th century. It's a Wild West," says Dr. Paul Knoepfler, a stem cell researcher at the University of California at Davis.
The FDA letter to Dr. Gionis, dated Dec. 30, provides some insight into how the FDA is addressing the issue. In difficult-to-parse language, it says that the substance that Gionis is processing and injecting amounts to a drug that has not been approved for safety and usefulness.
The writer, Mary Malarkey, director of an office in the FDAs Center for Biologics and Research, says that if Gionis maintains his treatments are part of a clinical trial, as his website suggests, he would need to submit an Investigational New Drug (IND) application to FDA.
The FDA official says an earlier defense by the clinic that the chemical used in the mixture has been changed doesnt make it acceptable without more information.
Health News Florida was not able to reach Dr. Gionis on Monday, but left a message with his staff.
The Associated Press reported last May that entrepreneurial ventures using fat-derived stem cells have proliferated throughout the country. Scientists engaged in authorized stem-cell research said states have not stepped up to regulate the ventures and called on FDA to do so.
The FDA has scheduled a public hearing for April on draft guidelines for fat-derived stem-cell treatments that the agency released a few months ago. That led some to mistakenly think the treatments are being subjected to new regulations, said FDA spokeswoman Sarah Peddicord. She said the regulations went into effect in 2005.
The law has not changed, she said. What the agency released are guidelines that FDA hopes will help the industry and the public understand the law.
People need to understand how to implement the regulations, she said. The guidelines are just to explain the regulations.
Stem cells have long been recognized for their ability to reproduce and regenerate tissue. And while there are high hopes that they will someday be used to treat a range of debilitating diseases, critics say stem cell entrepreneurs have little more than anecdotes to support their offerings.
In 2010, there were only a handful of doctors promoting stem cell procedures in the U.S., mainly plastic surgeons promoting "stem cell facelifts" and other cosmetic procedures. But today there are clinics throughout the country promoting stem cells for dozens of conditions and diseases, including Alzheimer's, arthritis, erectile dysfunction and hair loss. The cost of these procedures is high, ranging from $5,000 to $20,000.
Many of the businesses are linked in large, for-profit chains which offer doctors the chance to join the franchise after taking a seminar and buying some equipment.
The largest of these chains is the Cell Surgical Network, co-founded in 2012 by Dr. Mark Berman, who spent 30 years as a Beverly Hills plastic surgeon before working with stem cells. His company offers stem cell procedures for more than 30 diseases and conditions, including Lou Gehrig's disease, multiple sclerosis and arthritis.
He and his partner adapted technology from Asia into a liposuction-based procedure in which fat is pumped out of patients' abdomen, processed with drugs and equipment and then injected back into the body.
Berman says this fat-based "soup," is rich in shape-shifting stem cells that have the potential to treat everything from neurological diseases to achy joints.
"I don't even know what's in the soup," says Berman. "Most of the time, if stem cells are in the soup, then the patient's got a good chance of getting better."
The clinics insist that their treatments are safe, but routinely require that patients sign waivers.
Patients of Dr. Zannos Grekos, a Florida cardiologist specializing in stem cell therapy, were also required to sign a consent form, acknowledging the procedures' risks, including death.
But families of two Grekos patients who died under his care say he downplayed the risks. Gina Adams, daughter of patient Richard Poling, says her family was told her father would be "back on the golf course the next day" after a procedure intended to treat a lung condition that made breathing difficult. The cost was $8,000.
In March 2012, Grekos harvested fat from Poling's abdomen and sent it to an off-site processing facility to isolate the stem cells. Later that afternoon, he directed an assistant to infuse the resulting mixture into the patient's bloodstream.
Poling suffered cardiac arrest and was pronounced dead after being rushed to a local hospital.
Two years earlier, in 2010, 69-year old Domenica Fitzgerald suffered a stroke after Grekos infused unfiltered bone marrow-derived stem cells into the arteries of her brain. The state report concluded "it was virtually inevitable that the procedure would clog blood vessels in the brain and cause a major and very possibly fatal stroke." Fitzgerald suffered severe brain damage and was removed from life support several days later.
Jack Fitzgerald says his wife, who used a wheel chair, had hoped that stem cells might help her walk again.
Not until 2013, after Poling's death, did the Florida Board of Medicine vote to revoke Grekos' license.
Though barred from practicing medicine in Florida, Grekos continues to treat patients in the Dominican Republican through his company Regenocyte, which promotes treatments for autism, dementia and many other diseases.
He believes the two deaths were unrelated to his care the state targeted him to discourage other doctors from working with stem cells, he says.
State actions against stem cell doctors are rare. That's led industry critics to conclude that regulation must come from the FDA, which regulates medical products on a national level.
But the FDA's authority to regulate stem cell procedures is not clearly defined and has been debated by legal experts for years.
Now, the FDA appears to be stepping up its oversight. In the last days of 2014, it released draft guidelines dealing with the popular fat-based stem cell technique. The agency said that processing fat to extract stem cells for medical use essentially creates a new drug, which cannot be sold in the U.S. without the agency's approval.
But many stem cell doctors continue to argue that they don't need FDA permission because they are not creating drugs, but performing in-office surgical procedures.
For now, Berman says he has no plans to change his business.
"How is it unethical if you're actually helping people, even if we don't have evidence-based studies to prove it?" he asks.
Carol Gentry is a special correspondent for WUSF in Tampa. Health News Florida receives support from the Corporation for Public Broadcasting.
- Select residents with high-risk health issues will start getting a booster shot starting tomorrow - Newstalk 610 CKTB (iHeartRadio) - August 31st, 2021
- Princeton To Offer Third Dose Of COVID-19 Vaccine In September - Reverb MSN Music - August 31st, 2021
- A Third Dose of the COVID-19 Vaccine Recommended for Some Cancer Patients With Weakened Immune Systems - On Cancer - Memorial Sloan Kettering - August 18th, 2021
- Exclusive Report on Stem Cell Therapy in Cancer Market | Analysis and Opportunity Assessment from 2021-2028 |Aelan Cell Technologies, Baylx, Benitec... - August 5th, 2021
- Global Cell Therapy Bioprocessing Market Scope and Forecast By 2021-2027 I Top key players- Fresenius Kabi SA, Asahi Kasei Corporation, The Manomet... - August 5th, 2021
- The Oncology Institute of Hope and Innovation (TOI) Expands to San Diego County - Yahoo Finance - August 5th, 2021
- Covid-19 and the blood - Trinidad & Tobago Express Newspapers - August 5th, 2021
- Rheumatoid Arthritis Stem Cell Therapy Market Size, Status and Precise Outlook During 2020 to 2026 The Manomet Current - The Manomet Current - June 25th, 2021
- Canine Stem Cell Therapy Market Sustains Competitiveness by Adoption of Technological Innovations by 2021-2027 The ERX News - The ERX News - June 25th, 2021
- Global Rheumatoid Arthritis Market is Booming in Near Future with Speedy Growth, Key Players International Stem Cell Corporation, Takeda. The... - June 25th, 2021
- FDA to Crack Down on Stem Cell Clinics With Unproven Therapies - Bloomberg Law - June 8th, 2021
- Global NK Cell Therapy and Stem Cell Therapy Market Stock Analysis, Impact of COVID-19 on Sales, Business Opportunities, Trends 2020 (Chipscreen... - June 8th, 2021
- Stem Cell Manufacturing Market Size, Business Growth Tactics, Future Strategies, Competitive Outlook and Forecast to 2027 The Courier - The Courier - June 8th, 2021
- Rheumatoid Arthritis Stem Cell Therapy Market share, growth drivers, demand, supply, challenges, and investment opportunities by 2028 - WhaTech - May 28th, 2021
- Stem Cell Therapy Market Size to Witness Huge Growth by 2025 KSU | The Sentinel Newspaper - KSU | The Sentinel Newspaper - April 18th, 2021
- QC Kinetix (Myrtle Beach) is the Stem Cell Therapy and Regenerative Medicine Clinic Myrtle Beach - Press Release - Digital Journal - April 18th, 2021
- Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Comprehensive Analysis on Global Market Report by Company, by Dynamics, by Region, by... - April 18th, 2021
- Dad needs 300k for CAR-T cancer therapy in US or Israel - The Northern Echo - April 18th, 2021
- Global Automated and Closed Cell Therapy Processing Systems Market Trends and Forecasts, 2020-2030: Cell Processing Steps, Scale of Operations, End... - April 4th, 2021
- Hair Restoration Market Size Worth $13.6 Billion By 2028 | CAGR: 15.4%: Grand View Research, Inc. - PRNewswire - April 4th, 2021
- How Aviv Clinics in Florida's The Villages Retirement Community Fights Aging - menshealth.com - April 4th, 2021
- $16.89 Billion Nerve Repair and Regeneration Markets, 2026 - PRNewswire - April 4th, 2021
- Stem Cell Therapies Market Current Scenario Trends, Comprehensive Analysis and Regional Forecast to - PharmiWeb.com - March 8th, 2021
- NK Cell Therapy and Stem Cell Therapy Market Size, Industry Analysis, Growth Factors, Trends, and Regional Forecast to 2027 - KSU | The Sentinel... - March 8th, 2021
- Chemotherapy-Induced Myelosuppression Treatment Market 2021 Revenue, COVID Impact Analysis Report, I - PharmiWeb.com - March 8th, 2021
- Global Nerve Regeneration and Repair Market Estimated To Expand At A Robust CAGR By 2026||Boston Scientific Corporation, Alafair Biosciences,... - February 17th, 2021
- Adult T-Cell Leukemia/Lymphoma Treatment Market 2021 Present Scenario on Growth Analysis and High Demand to 2025 KSU | The Sentinel Newspaper - KSU |... - February 17th, 2021
- Canine Stem Cell Therapy Market Is Projected To Reach 240.7 Million US$ By 2026 | Key Players, Market Dynamics, Market Trends, And Forecast. KSU |... - February 11th, 2021
- Outlook on the Cell Therapy Global Market to 2027 - Opportunity Analysis and Industry Forecasts - Yahoo Finance - February 11th, 2021
- Australia's best performing IVF clinics revealed - Queensland Times - February 11th, 2021
- Stem cell and allergy clinics receive CBER untitled letters - Regulatory Focus - January 31st, 2021
- Mucopolysaccharidosis (MPS) Treatment Market: Stem Cell Therapy Research to Prominently Uphold Growth Outlook: Global Industry Analysis 2014-2018 and... - December 26th, 2020
- Stem Cell Clinics: Effective or Pricey False Hope? - December 17th, 2020
- FDA Warns About Stem Cell Therapies | FDA - December 17th, 2020
- Global NK Cell Therapy and Stem Cell Therapy Market: Development, Current Analysis and Estimated Forecast to 2025 - The Courier - December 17th, 2020
- California's Proposition 14: short in the arm for stem cell research - BioNews - December 16th, 2020
- Canine Stem Cell Therapy Market Key Trends, Drivers, Challenges And Standardization To 2020-2025 - The Haitian-Caribbean News Network - December 6th, 2020
- Stem Cell Manufacturing Market Analysis by Industry Size, Share, Key Drivers, Growth Factors, Demands, Top Manufacturers- Merck Group, Becton,... - December 1st, 2020
- Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market: The Next Big Innovation in Machinery Industry 2020|, Orange County Hair... - November 29th, 2020
- Comprehensive Report on Canine Stem Cell Therapy Market Set to Witness Huge Growth by 2026 | VETSTEM BIOPHARMA, Cell Therapy Sciences, Regeneus,... - September 27th, 2020
- Nancy Lane, MD: The State of Osteoarthritis and Osteoporosis - MD Magazine - September 14th, 2020
- NK Cell Therapy and Stem Cell Therapy Market Research, Clinical Study and Business Guidelines till 2026 | Chipscreen Biosciences Innate Pharma SA ... - September 12th, 2020
- Serving every person in the Summit County community - Summit Daily News - September 11th, 2020
- Coronavirus Disease (COVID-19) Impact Global Canine Stem Cell Therapy Market Report Top Companies like VETSTEM BIOPHARMA, Cell Therapy Sciences,... - September 11th, 2020
- Clinics 'peddling false hope for autism with potentially hazardous 14,000 cell therapy' - Mirror Online - September 5th, 2020
- Global Rheumatoid Arthritis Stem Cell Therapy Market Dynamics, Forecast, Analysis and Supply Demand 2018 to 2028 - Scientect - September 3rd, 2020
- Stem Cell Therapy Market Detailed Analysis of Current Industry Figures with Forecasts Growth By 2025 - Express Journal - August 28th, 2020
- Stem Cell Therapy Market: Trends, Applications, Industry Competitive Analysis, Growth,Forecast: 2019 to 2029 - The Scarlet - August 28th, 2020
- Global Canine Stem Cell Therapy Market 2027 Register a Xx% CAGR In Terms Of Revenue: VETSTEM BIOPHARMA, Cell Therapy Sciences, Regeneus, Aratana... - August 12th, 2020
- Joliet toddler with cancer missed 2nd birthday at home due to Chicago riots - The Herald-News - August 11th, 2020
- Global Cell Therapy Technologies Market : Industry Analysis and Forecast (2019-2026) by Product, Technique, End Users and Region. - Good Night, Good... - August 11th, 2020
- Global Nerve Repair and Regeneration Market Outlook 2020: Company Profiles of Key Players Axogen, Baxter, Nevro, Nuvectra, Polyganics and Stryker -... - August 10th, 2020
- Impact of COVID-19 Outbreak on Canine Stem Cell Therapy Market Expected to Secure Notable Revenue Share During 2020-2026 - Research Newspaper - August 7th, 2020
- Flow Cytometry Market 2020 | Research Objectives and Methodology, Growth Analysis, Top Manufacturers Sales, and Cost Structures Forecast 2024 - Owned - July 31st, 2020
- Unproven stem cell therapies, and now, strong words from the FDA - BioNews - July 27th, 2020
- Choosing a Stem Cell Clinic: 3 Critical Questions You Must ... - July 23rd, 2020
- FDA extends deadline for stem cell clinics to comply with ... - July 23rd, 2020
- Post COVID 19 Pandemic Global Canine Stem Cell Therapy Market Research Report 2020 Top Players Include, VETSTEM BIOPHARMA, Cell Therapy Sciences,... - July 16th, 2020
- Nebraska AG files lawsuit against Omaha stem cell clinic - Lincoln Journal Star - July 16th, 2020
- Canine Arthritis Treatment Market Size, Share 2020 Supply-Demand, Industry Research and End User Analysis, Outlook 2025| Says MRE Reports - Jewish... - July 14th, 2020
- Stem Cell Panel Market Is Forecasted To Register A CAGR Growth Of XX% Between And 2019 2029 - 3rd Watch News - July 12th, 2020
- Global Nerve Regeneration and Repair Market 2020, Research Report Covers Updated Data Considering Impact of Covid-19 on Share, Size and Future Demand-... - July 11th, 2020
- Global Skin and Wound Care Market is expected to grow at a CAGR of 3.84% during the forecast period - PharmiWeb.com - July 10th, 2020
- Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market 2020:Key market Insights, Drivers and Restraints, Opportunities and Challenges,... - July 8th, 2020
- Canine Arthritis Treatment Global Projection: 2020 Opportunities, Key Players, Competitive and Regional Analysis by Forecast 2025 - 3rd Watch News - July 8th, 2020
- Lysosomal Disease Treatment Market Size, Global Analytical Overview, Growth Factors, Technologies, Trends and Forecast To 2025 - 3rd Watch News - July 4th, 2020
- Global NK Cell Therapy and Stem Cell Therapy Market Top Key Players, Regions, Type and Application Outlook Upto 2020 to 2025 - 3rd Watch News - July 1st, 2020
- The Trouble With Stem Cell Therapy - Consumer Reports - July 1st, 2020
- Orthobiologics Market 2019 | How The Industry Will Witness Substantial Growth In The Upcoming Years | Exclusive Report By MRE - Cole of Duty - June 27th, 2020
- Trending: Canine Arthritis Therapeutics Market Research by Key players, Type and Application, Future Growth to 2026 - Cole of Duty - June 26th, 2020
- Update on FDAs Comprehensive Regenerative Medicine Framework: Looming November 2020 Deadline Preceded by a Flurry of Letters from CBER and a New JAMA... - June 24th, 2020
- Global Canine Stem Cell Therapy Market with (Covid-19) Impact Analysis: Future Development, Business Growth and Applications to 2025 - Cole of Duty - June 24th, 2020
- Graham Company and Regenexx Announce Innovative Partnership to Reduce Orthopedic Surgical Spend for Employers - Stockhouse - June 24th, 2020
- Stem Cell Cartilage Regeneration Market Overview By Growing Demands, Trends And Business Opportunities 2020 To 2027 - 3rd Watch News - June 24th, 2020
- Global Nerve Regeneration and Repair Market Growth Factors And Global Leading Players Are Abbott, Integra LifeSciences Corporation, Nevro Corp.,... - June 18th, 2020
- Canine Stem Cell Therapy Market to Expand with Significant CAGR - WorldsTrend - June 12th, 2020
- R3 International Now Offering New Stem Cell Therapy Program for Lyme Disease in Mexico - PR Web - June 10th, 2020
- Canine Arthritis Treatment Market to Witness heightened Growth with Extension of COVID-19 Pandemic and Forecast 2027 - Cole of Duty - June 10th, 2020
- Stem Cell Cartilage Regeneration Market Overview By Growing Demands, Trends And Business Opportunities 2020 To 2027 - Cole of Duty - June 2nd, 2020
- Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market to Grow Significantly With Increasing Advancements in Technology, Says QYR - News... - June 2nd, 2020