Getty Images/Spencer Platt
Stem cell science is an area of medical research that continues to offer great promise. But as this weeks paper in Science Translational Medicine highlights, a growing number of clinics around the globe, including in Australia, are exploiting regulatory gaps to sell so-called stem cell treatments without evidence that what they offer is effective or even safe.
Such unregulated direct-to-consumer advertising typically of cells obtained using liposuction-like methods not only places the health of individuals at risk, but could also undermine the legitimate development of stem cell-based therapies.
Many academic societies and professional medical organisations have raised concerns about these futile and often expensive cell therapies. Despite this, national regulators have typically been slow or ineffective in curtailing them.
As well as tighter regulations here, international regulators such as the World Health Organisation and the International Council on Harmonisation need to move on ensuring patients desperate for cures arent sold treatments with limited efficacy and unknown safety.
Hundreds of stem cell clinics post online claims that they have been able to treat patients suffering from a wide range of conditions. These include osteoarthritis, pain, spinal cord injury, multiple sclerosis, diabetes and infertility. The websites are high on rhetoric of science often using various accreditation, awards and other tokens to imply legitimacy but low on proof that they work.
osteoporosis strong bones workout old lady
Donna McWilliam/APRather than producing independently verified results, these clinics rely on patient testimonials or unsubstantiated claims of improvement. In so doing these shonky clinics understate the risks to patient health associated with these unproven stem cell-based interventions.
Properly administered informed consent is often overlooked or ignored, so patients can be misled about the likelihood of success. In addition to heavy financial burdens imposed on patients and their families, there is often an opportunity cost because the time wasted in receiving futile stem cells diverts patients away from proven medicines.
The many recent reports of adverse outcomes demonstrate the risks of receiving unproven cell therapies are not trivial. In the USA three women were blinded following experimental stem cell treatment for macular degeneration (a degenerative eye disease that can cause blindness). One man was rendered a quadriplegic following a stem cell intervention for stroke. And a woman whose family sought treatment for her dementia died in Australia.
Other notorious cases involving the deaths of patients include the German government shutting down the X-Cell Centre and the Italian government closing the Stamina Foundation it had previously supported.
REUTERS/Juan Carlos UlateAt present, the only recognised stem cell treatments are those utilising blood stem cells isolated from bone marrow, peripheral blood (the cellular components of blood such as red and white blood cells and platelets) or umbilical cord blood.
Hundreds of thousand of lives have been saved over the last half-century in patients with cancers such as leukaemia, lymphoma and multiple myeloma, as well as rare inherited immune and metabolic disorders.
A few types of cancer and autoimmune diseases may also benefit from blood stem cells in the context of chemotherapy. Different stem cells are also successfully used for corneal and skin grafting.
All other applications remain in the preclinical research phase or are just starting to be evaluated in clinical trials.
Often dismissed by for-profit clinics as red tape hampering progress, the rigour of clinical trials allows for the collection of impartial evidence. Such information is usually required before a new drug or medical device is released into the marketplace. Unfortunately, in the case of for-profit stem cell clinics, their marketing has gazumped the scientific evidence.
Action is required on many fronts. Regulators at both an international and national level need to tackle regulatory loopholes and challenge unfounded marketing claims of businesses selling unproven stem cell interventions.
Researchers need to more clearly communicate their findings and the necessary next steps to responsibly take their science from the laboratory to the clinic. And they should acknowledge that this will take time.
Patients and their loved ones must be encouraged to seek advice from a trained reputable health care professional, someone who knows their medical history. They should think twice if someone is offering a treatment outside standards of practice.
The stakes are too high not to have these difficult conversations. If a stem cell treatment sounds too good to be true, it probably is.
NOW WATCH: How grown men can actually look good in shorts
- Judge Says FDA Can Stop Clinic from Selling Stem Cell ... - May 21st, 2020
- Saad Z. Usmani, on the Approval of Daratumumab and Hyaluronidase-fihj - Cancer Network - May 19th, 2020
- R3 Stem Cell International Now Offering Enhanced Autism Stem Cell Program in Mexico - PR Web - May 19th, 2020
- Stem Cell Concentration System Market Report 2020: Rising Impressive Business - News by aeresearch - May 19th, 2020
- Precision therapy approach secures small biotech $42M haul to combat disease that inspired the Ice Bucket Challenge - Endpoints News - May 19th, 2020
- QurAlis raises $42 Million Series A Financing to Develop New Therapies for Amyotrophic Lateral Sclerosis (ALS) - Business Wire - May 17th, 2020
- Coronavirus Outbreak: Cancer Stem Cell Therapy Market Overview and Competitive Landscape 2020 to 2025 - Cole of Duty - May 15th, 2020
- Intellia Therapeutics Reports Progress on CRISPR/Cas9 AML Cancer Therapy Using Proprietary Cell Engineering Process at the 23rd Annual Meeting of the... - May 12th, 2020
- Vasomune Therapeutics Announces Clinical and Scientific Advisory Board - BioSpace - May 12th, 2020
- Orgenesis sees 1Q revenue rocket driven by its Cell and Gene Therapy Biotech platform - Proactive Investors USA & Canada - May 12th, 2020
- Orgenesis First Quarter 2020 Revenue Increases 348% to $1.9 Million Reflecting Success of CGT Biotech Platform - GlobeNewswire - May 12th, 2020
- Meat the Future - documentary Channel - CBC.ca - May 10th, 2020
- Researchers discover stem cells' 'death-defying' quality that aids healing - ETHealthworld.com - May 10th, 2020
- On the Road As a Stem Cell Courier - CSRwire.com - May 3rd, 2020
- You could be someones only hope: A stem cell donor campaigning to beat blood cancer - Evening Standard - May 3rd, 2020
- David C. Karli is Offering a New Ray of Hope Through Regenerative Medicine - RESPECT. - May 3rd, 2020
- FDA Expediting Accelerated Development of Novel Therapies for COVID-19 - PR Newswire UK - May 3rd, 2020
- What to do if you think you have COVID-19: a step by step guide - The Dickinson Press - April 21st, 2020
- Stem cells in the clinic: how are they regulated? - European Pharmaceutical Review - April 20th, 2020
- NHS's oldest IVF clinic at risk of closure amid increasing privatisations - The Guardian - April 20th, 2020
- Here are the drugs that could treat coronavirus. But don't expect a silver bullet. - The Philadelphia Inquirer - April 18th, 2020
- Analyzing the Outcomes With Different Treatment Techniques in Myeloma - Targeted Oncology - April 18th, 2020
- Team to Advance Stem Cell Therapies in New Space Station Lab - Lab Manager Magazine - April 11th, 2020
- Hackensack Meridian Health Studying the Blood of COVID-19 Survivors - P&T Community - April 11th, 2020
- UC San Diego to Advance Stem Cell Therapies in New Space Station Lab - UC San Diego Health - April 9th, 2020
- Orgenesis partners with Belgium"s RevaTis to develop stem cells for therapeutic use - Proactive Investors USA & Canada - April 9th, 2020
- AgeX Therapeutics Reports Fourth Quarter and Annual 2019 Financial Results and Provides Business Update - Yahoo Finance - March 31st, 2020
- Larkhall mum was walked down the aisle by stem cell donor who saved her life - Daily Record - March 31st, 2020
- Q&A: Covid-19 and impact on people with cancer - The Irish Times - March 30th, 2020
- COVID-19 and Cancer: What You Need to Know - Everyday Health - March 30th, 2020
- Cancer Stem Cell Therapy Value Projected to Expand by 2019-2025 - Monroe Scoop - March 27th, 2020
- Unlocking the Potential of a Widely Used Drug - Technology Networks - March 25th, 2020
- Cancer Care and COVID-19 in Seattle, the First US Epicenter - Medscape - March 24th, 2020
- Immatics and Molmed become the subjects of very different deals - Vantage - March 21st, 2020
- Claudia Rodrigues is removed from the clinic where she was hospitalized because of the coronavirus - Crypto Dictation - March 21st, 2020
- Stem cells can reverse damage caused by heart attack; repair mechanism discovered: Study - International Business Times, Singapore Edition - March 16th, 2020
- Newly Discovered Memory in Our Bones: Keeping a Record of Previous Infections to Boost Immunity - SciTechDaily - March 16th, 2020
- The race to find a coronavirus treatment: One strategy might be just weeks away, scientists say - USA TODAY - March 16th, 2020
- Cancer Stem Cell Therapy Market Global Size, Demand-sales, Suppliers by Key Applications 2019 Detailed Analysis and Growth Aspects on Manufacturing... - March 15th, 2020
- Woman meets stranger who saved her life and allowed her to become a mum - Mirror Online - March 15th, 2020
- Stem Cell Manufacturing Market Analysis By Recent Trends, Developments In Top Manufacturing Technology And Regional Growth Overview And Forecast To... - March 11th, 2020
- Kuur Therapeutics Launches to Develop and Commercialize Off-the-shelf CAR-NKT Cell Therapies Targeting Hematological and Solid Tumors | DNA RNA and... - March 11th, 2020
- The London Patient, Cured of H.I.V., Reveals His Identity - The New York Times - March 11th, 2020
- Cancer Stem Cell Therapy Market 2019- Emerging Economies Expected to Influence Growth by 2025 with Major Players-AVIVA BioSciences, AdnaGen, Advanced... - March 10th, 2020
- Maryland Booms in the BioCapital Hotbed - BioSpace - March 10th, 2020
- Gilead to Acquire Immuno-Oncology Company Forty Seven for $4.9 Billion - PharmaLive - March 5th, 2020
- THC Could Be First-of-its-Kind Treatment for Women With Endometriosis, Says New Study - Good News Network - March 5th, 2020
- Autolus Therapeutics Plc (AUTL) QEarnings Call Transcript - Motley Fool - March 5th, 2020
- CytoDyn Treats First Patient with Leronlimab in Phase 2 Trial for GvHD under Modified Trial Protocol - Yahoo Finance - March 5th, 2020
- Magenta Therapeutics Reports Fourth Quarter and Full Year 2019 Financial Results and Recent Business Highlights - Yahoo Finance - March 4th, 2020
- Omeros Corporation Reports Fourth Quarter and Year-End 2019 Financial Results - Business Wire - March 4th, 2020
- Animal Stem Cell Therapy Market by Segmentation Based on Product, Application and Region, 2019-2025 - Jewish Life News - February 29th, 2020
- Indiana Regenerative Medicine Institute Offers Innovative Approaches in Regenerative Medicine, Hormone Replacement and Pain Management - Zionsville... - February 29th, 2020
- Hyperbaric chamber therapy: Im under a lot of pressure and I love it! - The Guardian - February 25th, 2020
- DDP and Austin Aries Reportedly Pitching Stem Cell Venture to AEW | 411MANIA - 411mania.com - February 25th, 2020
- Why Austin Aries and Raven Were At AEW Dynamite - PWMania - February 25th, 2020
- Austin Aries Confirms Why He Was At AEW Dynamite This Week - 411mania.com - February 24th, 2020
- BrainStorm Announces Operational Highlights and Financial Results for the Year Ended December 31, 2019 Conference Call and Webcast @ 8:00 am Eastern... - February 18th, 2020
- Animal Stem Cell Therapy Market Projected to Witness Vigorous Expansion by 2017 2025 - Instant Tech News - February 18th, 2020
- 6 Healthcare Stocks That Could Make You Filthy Rich - The Motley Fool - February 18th, 2020
- Mixed ethnic backgrounds make it that much harder to find a bone marrow transplant - MLive.com - February 17th, 2020
- 48% of Couples Are Making This Financial Mistake - Nasdaq - February 17th, 2020
- 'Loving life': 4-year-old not letting heart condition slow him down - Port Clinton News Herald - February 15th, 2020
- Cancer Stem Cell Therapy Market Trends, Key Players, Overview, Competitive Breakdown and Regional Forecast by 2025 Mathematics Market Methods - Keep... - February 15th, 2020
- Regenexx, First to Use Stem Cells in Orthopedic Therapy, Marks 15th Anniversary - Yahoo Finance - February 12th, 2020
- What Drives the Domino Effect in Cancer Drug Resistance? - Technology Networks - February 12th, 2020
- CRISPR, CAR-T, Consolidation: Top Advanced Therapy Milestones of 2019 - Xconomy - February 12th, 2020
- Science team designs a new CAR they say may work much better than BCMAs in fighting multiple myeloma - Endpoints News - February 12th, 2020
- Omeros: 2 Major Catalysts On The Horizon - Seeking Alpha - February 10th, 2020
- Blood In The Joint - Economic Times - February 10th, 2020
- PRACTICALLY ACTIVE: Screening is a smart way to start a healthier life - NWAOnline - February 10th, 2020
- Anemia: Causes, symptoms and treatment - Livescience.com - February 6th, 2020
- Here's Why CRISPR Stocks Fell in January - The Motley Fool - February 6th, 2020
- Victoria Beckham says this product is the best product you will ever use - Marie Claire UK - February 6th, 2020
- Korzan: On World Cancer day, pledge to be relentless - AberdeenNews.com - February 5th, 2020
- Global Radiation Therapy Market to Reach US$ 8.6 bn by 2026, Product Approvals to Drive Growth: Transparency Market Research - PRNewswire - February 5th, 2020
- SASpine to offer Stem Cell Therapy - Yahoo Finance - February 4th, 2020
- Dr. Kenneth Pettine Announces Verification of Clinical Safety Trial - Yahoo Finance - February 4th, 2020
- The Marsh Presents Welcome to The Cancer Caf - Patch.com - February 4th, 2020
- Freeport stem cell therapy provider Okyanos in wind-up petition battle - EyeWitness News - February 4th, 2020