Stem Cell Lawsuit - Injured by a Stem Cell Products or Therapy?
Seeking Stem Cell Patients Who Have Experienced Complications or Adverse Medical Events
[Last update September 2020] The future of medicine is upon us – stem cell therapy. Using stem cells to regenerate or replace damaged tissue or diseased cells is a technique that is offering new life to millions of patients.
Like any other medical treatment, stem cell treatments come with a number of risks and side effects, including stem cell rejection, Graft-Versus-Host disease (GVHD), fatigue, bruising and many other side effects associated with stem cell procedures.
But some stem cell products carry greater, life-threatening risks.
Most Americans feel that stem cells are safe as long as they are FDA-approved or authorized for use in clinical trials. And this absolutely should be the case.
However, stem cell companies feeling pressured to keep up with a highly competitive market may skimp on quality control and ignore safe manufacturing requirements. Fly-by-night stem cell companies and clinics may use unsafe manufacturing conditions to save on costs, resulting in dangerous stem cell contamination and deadly patient infections. We spoke to one insider who said his company shipped products even though lot samples tested positive for e. coli!
Stem cell manufacturers and distributors who produce dangerous, defective, or contaminated stem cell products face criminal and civil penalties. Injured stem cell patients have the right to file a lawsuit for damages, including past and future medical expenses, lost wages, pain and suffering, and other damages.
In an effort to crack down on this dangerous practice, our stem cell lawsuit team is currently prosecuting several of these cases. We are also working alongside the FDA, Department of Justice (DOJ) and Department of Health and Human Services Office of the Inspector General (HHS-OIG), to stop these companies from hurting other patients.
What Is Stem Cell Therapy?
Stem cells are cells found naturally in the body. But they are different from the majority of our body’s cells in that stem cells come from our own embryonic development. They exist throughout our lives, acting as a preliminary supply of cells from which new cells are derived.
As our body’s cells are damaged or die, stem cells are triggered to become or help create new, healthy cells to replace them. Here are some examples of human tissues containing stem cells:
Adult Stem Cells (tissue-specific)
- Bone marrow stem cells create platelets, red blood cells and white blood cells (hematopoietic)
- Blood vessel stem cells regenerate new vessel walls
- Skeletal muscle stem cells help repair and replace damaged muscle
- Liver stem cells repair and replace damaged liver tissue
- Skin stem cells constantly generate new skin cells
- Mesenchymal skin cells become fat cells, cartilage, and bone
Embryonic Stem Cells
- Embryonic skin cells are the earliest stage of stem cell, growing and differentiating to eventually form every type of tissue in the human body
Stem cells vary depending on the tissue they are taken from. Some can become any type of cell in the body, while others can become only one type of cell.
Injecting stem cells, implanting stem cells or growing stem cells to make artificial tissues have proven effective against numerous diseases. They are one of the most promising tools in modern medicine.
Doctors currently use umbilical cord cells and adult stem cells to treat diseases like leukemia, multiple myeloma, lymphoma, neuroblastoma, and sickle cell anemia. Researchers are currently testing stem cell therapies to treat other types of cancers, heart disease, spinal cord injuries, stroke, type I diabetes, Alzheimer’s disease, amyotrophic lateral sclerosis, Parkinson’s disease, severe burns, and osteoarthritis.
Scientists are also working on developing tissue regeneration techniques to grow organs and tissue for transplant, making everything from skin grafts and new blood vessels to healthy brain cells, heart cells, and kidney cells.
Unfortunately, there are is a small group of folks who are exploiting the promise of stem cell therapy and either making wild (and unsupportable) claims, operating from un-inspected and rudimentary labs or shipping freeze dried stem cells. (If a product is freeze dried, the stem cells are usually dead. Dead stem cells can't regenerate new cells!)
List of Stem Cell Products and Manufacturers
FDA Approved Stem Cell Products
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.
FDA Designated Stem Cell Therapies
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.
We are aware of many on-going clinic trials and drugs in development. As of the time this post is written, we are aware of these companies but not aware of any FDA approvals. (In our experience, many stem cell companies advertise or claim they have FDA approval. We suggest you obtain proof before being injected.)
- AST-OPC1 - Asterias Biotherapeutics
- MultiStem - Athersys
- CEVA101 - Cellvation Inc. (Fortress Biotech Co.)
- jCell – jCyte
- MPC-150-IM - Mesoblast, Ltd.
- Ixmyelocel-T - Vericel Corp.
- CLBS14 - Caladrius Biosciences
- CAP-1001 - Capricor Therapeutics
- Romyelocel-L - Cellerant Therapeutics, Inc.
- P-BCMA-101 - Poseida Therapeutics
Other stem cell companies and cell therapy manufacturers
In addition to FDA-approved and RMAT-designated stem cell products, stem cell companies across the globe are currently developing and testing stem cell therapies for use in humans.
Are Stem Cell Treatments Dangerous?
Like any other medical treatment, stem cell therapy comes with a number of risks and side effects. There are “indirect risks,” associated with other procedures like radiation or chemotherapy. There are also “direct risks” that come with receiving the cells themselves.
Direct risks associated with stem cell therapies are relatively minor and temporary, typically lasting until the treatment “takes” and the cells become established in the body. The main risk is developing GVHD, when the body’s immune system tries to reject the cells, attacking healthy cells in the process. Symptoms include rash, jaundice, fever, diarrhea, cramping and nausea.
Other side effects of stem cell therapies may include fatigue (from temporary anemia), bruising (from temporarily low platelet counts), infection (from a temporarily weakened immune system).
Doctors will evaluate a patient for any potential risks up front and plan to address these issues accordingly, delivering medications before, along with, or soon after the stem cells to alleviate any problems.
However, when stem cells are not prepared or marketed correctly, serious, and life-threatening illness can result. Poor stem cell manufacturing practices can easily lead to contaminated cells. If contaminated cells are injected, the patient may develop sepsis, leading to loss of limbs, organ failure or death.
If stem cells are marketed as one type of cell but actually contain a different type of cell, those injected stem cells may cause organ failure, develop into tumors, or simply won’t work as marketed – allowing the patient to progress in their illness.
Even if you receive your own stem cells (autologous stem cell therapy), you can still suffer from a laboratory’s poor cell acquisition process and bad preparation techniques. Your own stem cells can still become contaminated with viruses or bacteria during improper handling, causing highly dangerous infections after injection.
Stem Cell Recalls and Safety Warnings
As the FDA ramps up its fight against unsafe stem cell companies, more and more stem cell clinics and laboratories are being disciplined for dangerous stem cell manufacturing practices.
- In 2015, the Irvine Stem Cell Treatment Center received an FDA warning letter for violating current good manufacturing practice (cGMP) requirements.
- In 2016, the FDA ordered Amniotic Therapies, LLC. to cease manufacturing stem cell-based products after an inspection found failures to prevent contamination and other current good tissue practice violations.
- In 2017, a U.S. Stem Cell Inc. subsidiary received an FDA warning letter for violating cGMP requirements.
- In 2018, Liveyon LLC. (national distributor of Genetech cell products) initiated a stem cell product recall (Regen Series) after the FDA notified the company of potential for adverse reactions. See our Liveyon ReGen investigation page.
- In 2018, StemGenex Biologic Laboratories received an FDA warning letter for cGMP violations and unlawful marketing of its unapproved stromal vascular fraction (SVF) product. See Our StemGenex investigation page.
- April, 2019 New York's Attorney General Sues Park Avenue Stem Cell for false advertising
- June, 2019 a federal judge ordered U.S. Stem Cell from injecting patients with fat after patients go blind.
- November, 2019 FDA issues warning letter to RichSource Stem Cells for making unapproved marketing claims to physicians. RichSource alleged claimed its RICHGEN products can help cure tumors, cancer, Lyme's disease, cOPD, arthritis and asthma. According to the letter, "We note that your product is intended to treat a variety of diseases or conditions, including some that are serious or life-threatening. Such unapproved uses raise potential significant safety concerns. Additionally, because the product is administered by various higher risk routes of administration, including via spinal injections, their use, if contaminated could cause a range of adverse events."
- March 2020 FDA issues warning letter to Invitrx for unsanitary manufacturing practices and other serious violations. See our Invitrx lawsuit page.
- June 2020, the FDA claims that EUCYT Labs of Las Vegas, Nevada is peddling dangerous products with poor quality control and unsafe manufacturing practices. In November of 2019, several people in Nebraska suffered serious injuries after a EUCYT product was found to have been contaminated with E. coli.
FDA Advice for People Considering Stem Cell Therapies
Several stem cell companies claim that the FDA does not need to review or approve the treatment. That is not true. Others claim they have approval when they don't. The FDA recommends that if you are considering treatment do the following:
First, ask if the FDA has reviewed the treatment. Ask your health care provider to confirm this information. You also can ask for the FDA-issued Investigational New Drug Application number. Ask for this information before getting treatment— even if the stem cells are your own.
Second, request the facts and ask questions if you don’t understand. Make sure you understand the entire process and known risks before you proceed. You also can ask for a short description of the product and information about its safety and effectiveness.
How Do I File a Stem Cell Lawsuit?
Some stem cell products have received FDA approval and are already on the market. Others have obtained FDA investigational new drug (IND) approval or RMAT designation. According to the National Institutes of Health (NIH), more than 1,000 clinical trials examining stem cell therapies are currently underway.
All manufacturers of FDA-regulated stem cell products must adhere to strict FDA safety guidelines regarding manufacturing practices to ensure safety, potency, and purity. When they don’t, they face both criminal and civil penalties.
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.)
Since properly prepared stem cell therapies rarely cause serious complications, you may be eligible to file a stem cell lawsuit if you suffered serious injury due to a stem cell product. [See our contact information at the end of this post.]
To meet FDA current good manufacturing practices (cGMP) requirements, stem cell companies must maintain a sterile facility to prevent risk of contamination. Live stem cells must be irradiated to ensure no bacterial or viral contamination is present.
Stem cell companies must also only market their cells for uses approved by the FDA. Telling patients or doctors that a stem cell product FDA-approved for lymphoma treatment is “also useful for Type I diabetes treatment” is dangerous and illegal.
Many stem cell products are manufactured overseas, making efficient FDA regulation difficult. With an FDA staffing shortage, overseas stem cell companies aren’t worried about surprise inspections and often fail to maintain a sterile facility or have proper quality control testing.
Most stem cell companies know an FDA inspection is coming months in advance, giving them time to clean up equipment, falsify quality control data and hide violations.
Our stem cell injury lawyers are currently working with the federal government to uncover potentially dangerous stem cell products. We are interested in hearing from anyone who has experienced serious complications after stem cell therapy.
Working with our national network of dangerous drug lawyers, we can help you receive answers and compensation. Stem cell products may be the future of modern medicine. Unfortunately, there are far too many companies rushing into the field with untested or dangerous products and making wild claims of miracle cures.
Recently FDA Commissioner Scott Gottlieb M.D. said,
'The potential health benefits of regenerative medicine have spurred major progress in stem-cell biology over the past several decades. But we continue to see bad actors exploit the scientific promise of this field to mislead vulnerable patients into believing they’re being given safe, effective treatments; when instead these stem cell producers are leveraging the field’s hype to push unapproved, unproven, illegal, and potentially unsafe products. This is putting patients’ health at risk."
Until the industry and regulators can insure that all medical products are safe and used properly, we will continue to protect patients and step in when drug companies push dangerous products or make unsupported claims. If you are suffering from an adverse reaction from stem cell products, contact us right away.
What about a Class Action
There has already been one class action filed against a stem cell distributor, StemGenex. That case deals with false advertising claims.
If your only damages are a product that didn't work, consider yourself lucky. The StemGenex class may help you recover the $14,900 reportedly charged for treatment. If you were injured, however, a class action won't help. Class actions are great whenever has the same damages. They don't work for personal injury cases where one size does not fit all.
Call for Stem Cell Company Whistleblowers
We are also seeking anyone with information on FDA cGMP violations. That includes third-party agents, outsiders, and international parties.
Our primary focus is on patients. We bring stem cell lawsuit claims on behalf of patients suffering from serious side effects from bad products. We got our start, however, by helping healthcare workers put a stop to dangerous drugs and medical products. Because of the significant threat to public health, the FDA and the Department of Health and Human Services rely on patients, doctors, nurses, stem cell laboratory technicians and pharmaceutical sales representatives to report cases of adverse reactions to stem cell treatments, stem cell contaminations and poor manufacturing practices.
Present or former stem cell laboratory technicians, quality assurance (QA) professionals, pharmaceutical representatives, stem cell company executives, other stem cell safety or quality control specialists, physicians and nurses may be eligible for significant whistleblower awards under federal and state False Claims Acts.
You need not be a U.S. citizen or even a resident to report your concerns and receive a cash award.
Stem Cell Lawsuit Claims - The Process Starts Here
For more information on how to get reimbursed for your pain and suffering and medical bills, contact us immediately. Although most states give injured parties several years to file claims for defective products, we worry that many of these companies have little insurance. Some of these companies are literally set up in a garage. Typically the physicians, clinics and chiropractors that inject these products are better insured but many states require claims against doctors be filed within just 1 or 2 years from the date of injury.
To see if you have a claim for your injuries (or if you are an insider with information that can help patients) contact us by email at [hidden email], by phone at 800.669.7782, or online.
We couldn't resist. In June 2019, the FDA shut down U.S. Stem Cell's operation that offered stem cells made from fat tissue after two patients allegedly went blind and a third was in a coma for over a month. The CEO of the company also happens to be the president of the stem cell trade group.
We again repeat that we believe in stem cell therapy, just not the many of the early pioneers who make outrageous marketing claims with no studies to back them up, operate non sterile facilities and utilize untrained doctors and technicians.