Stem cell therapy is one of the most promising developments in medicine. Over 1000 trials are currently underway. While we are big supporters of stem cell research, few products have received FDA approval and of those that have, they are only approved for use in very particular situations.
Look at the Internet, however, and stem cell therapy can grow hair, restore hearing, regenerate damaged heart muscle, cure arthritis and cure just about anything else wrong with you. At best, these unapproved products are composed of freeze dried cells and will do nothing for you. In other words, you are out some serious money but the product won’t kill you.
That is the best case. The worst case is that the product was made with live stem cells and those cells are either contaminated with a communicable disease from an untested donor or have been contaminated with dangerous bacteria because of poor manufacturing practices. Despite the slick marketing brochures and videos clips showing state of the art cleanrooms, many stem cell production facilities are literally garage operations.
The industry is still in the Wild West phase and that means it is difficult to get accurate information. So what can you do to protect yourself? Here are some helpful tips.
Tips to Avoid Stem Cell Malpractice
Avoid Any Therapy or Product that Claims It Is No Risk. Every medical procedure involves some level of risk. There are many risks including improper donor testing and screening, unsanitary harvesting and processing practices, and Graft-Versus-Host disease (GVHD).
Check FDA Approvals. Simply because a clinic says its products are FDA approved (or that FDA approval is not needed) doesn’t mean its true.
Currently, the FDA has approved the following stem cell-based products for use in the United States. All come from cord blood and function to produce various blood cell types.
- ALLOCORD – SSM Cardinal Glennon Children’s Medical Center
- LAVIV (Azficel-T) – Fibrocell Technologies
- MACI – Vericel Corp.
- CLEVECORD – Cleveland Cord Blood Center
- GINTUIT – Organogenesis Incorporated
- HEMACORD – New York Blood Center
- Ducord – Duke University School of Medicine
- HPC Cord Blood – Clinimmune Labs, University of Colorado Cord Blood Bank
- HPC Cord Blood – MD Anderson Cord Blood Bank
- HPC Cord Blood – LifeSouth Community Blood Centers, Inc.
- HPC Cord Blood – Bloodworks
- IMLYGIC (talimogene laherparepvec) – BioVex, Inc. (Amgen Inc. subsidiary)
- KYMRIAH (tisagenlecleucel) – Novartis Pharmaceuticals Corporation
- LUXTURNA – Spark Therapeutics, Inc
- PROVENGE (sipuleucel-T) – Dendreon Corp.
- YESCARTA (axicabtagene ciloleucel) – Kite Pharma, Incorporated
- ZOLGENSMA (onasemnogene abeparvovec-xioi) AveXis, Inc.
Is the product you are considering not on the list? The link above has the most up-to-date FDA information.
As part of the 21st Century Cures Act (Dec. 2016), the FDA gives several unapproved stem cell therapies “Regenerative Medicine Advanced Therapy” (RMAT) designation. RMAT designated products, though not FDA-approved, have some preliminary clinical evidence of effectiveness against serious or life-threatening diseases for which no alternative treatment is available.
As of April 2020 (the date of the most recent FDA list) there were no RMAT products on the FDA’s approval list. Once again, check the FDA’s list online.
Don’t Trust Testimonials. Look at a cardiologist or neurologist’s website and most don’t have patient testimonials. We are aware that many stem cell clinics are filled with them. There is no way of telling if these testimonials are real.
Who Is Running the Clinic? We have found many stem cell clinics run by chiropractors, nurses and PhDs. Where are the medical doctors or osteopaths? Although licensing rules vary from state to state, we always prefer a licensed physician for treatment.
This advice is especially true if receiving stem cells for anything serious. If you have macular degeneration, see an eye specialist. Even if chiropractors are licensed in your state to administer stem cells, would you otherwise go to a chiropractor to treat blindness?
Beware the High Pressure Sales Pitch. Cardiologists don’t advertise “buy one get one” heart surgery sales. You don’t get three stents for the price of two. Once again, stem cell therapy is often the Wild West. If you are solicited at a free chicken dinner / seminar, think twice.
Beware Miracle Claims. We all want to feel and look younger. Snake oil salesmen were common in the middle 1800’s going door to door selling an elixir that was a guaranteed cure all for all your ailments. It rarely worked.
Fast forward to the 21 t century and poor quality stem cells are not only ineffective, they can kill you.
Remember, look for FDA approval of both the product and the cure.
Know the Source of the Stem Cells. Unless you are using your own tissue to generate stem cells, knowing the source of the stem cells is important. How do they test donors? How do they test them? Everything should be in writing.
Just like many seek a second opinion before major surgery, we recommend speaking with your own physician before receiving stem cells.
I Suffered Serious Complications from Stem Cell Therapy, How Do I Get Compensation?
We have seen far too many people seriously injured by contaminated stem cell products. If you are a victim of stem cell malpractice, you have the right to compensation.
How Do I File a Stem Cell Malpractice Lawsuit?
Patients injured by contaminated products have the right to file a stem cell lawsuit for financial compensation, including money to pay for past and future medical expenses, lost wages, pain and suffering, and other damages. (If a patient receives dead cells or if the company selling the cell products makes inaccurate claims about the effectiveness of its products, you may also have a claim for the cost of therapy.)
We have an entire post about stem cell lawsuits. That is a good place to start. (That page also has valuable links to specific stem cell company lawsuits and investigations.)
Ready to see if you have a stem cell malpractice case? Contact us by email at , by phone at 202-800-9791, or online. All inquiries are protected by the attorney – client privilege and kept confidential.