Regenerative medicine is an exciting field of research that includes cell and gene therapies, tissue engineering, and other types of treatments to regrow, repair or replace damaged or diseased cells, organs or tissues. Cell therapy is the transfer of cells into a patient with the goal of improving a disease. Stem cells are cells that can turn into any type of cell the body needs and have unique abilities to self-renew and to recreate functional tissues. Stem cells in particular offer great promise for new medical treatments.
Unfortunately, some unethical providers are taking advantage of this medical progress to offer cell therapy products that have not received the required regulatory review, are being offered illegally, have not been tested to see if they work, and may be dangerous.
By being aware of this problem, patients and their families can protect themselves from potentially harmful products. Read more below to learn about some of the signs that might help a person decide whether a provider of cell therapies can be trusted.
Unproven Stem Cell Products and FDA
There are many uses for stem cells that are supported by reputable medical research. For example, the Food and Drug Administration (FDA) has approved a few treatments that use stem cells from umbilical cord blood to treat types of cancer or immune disorders. For cell-based therapies, including stem cell products, FDA has specific rules and requires some products to go through the clinical trial process.
A clinical trial is a required part of the research process to study how a new drug or therapy interacts with the human body and to generate data on whether it is safe and effective. Clinical trials offer an opportunity for a patient to receive an investigational therapy that may treat their disease, while also supporting research that may help others with the same disease.
Unfortunately, some clinics may ignore FDA’s rules and administer stem cell products that have not gone through required trials, possibly claiming clinical trials are not required. These clinics also may offer these unproven stem cell products by pretending to be participating in a valid clinical trial overseen by the FDA. Patients should be on the lookout for both of these deceptive practices.
FDA explains why unproven stem cell products are a safety concern, and why regulating those products is important. If you or anyone in your life thinks they’ve suffered harm from an unproven cell therapy or a fraudulent clinical trial, FDA has an adverse event reporting system you can use.
Ways to Ensure a Clinical Trial Is Legitimate
There are a variety of reliable sources that can help people avoid unproven, potentially dangerous procedures that are offered under the false guise of a clinical trial. Here are some ways to check a trial’s legitimacy:
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Review the trial with a trusted healthcare professional and not just with the trial’s sponsoring clinic or organization. This professional could be your primary health care provider or disease specialist.
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When searching for a trial, use resources that check the trials that show up in their database, such as ClinicalTrials.gov or the Gene Therapy Trial Browser. Remember that just because a trial is listed on ClinicalTrials.gov, it does not mean it has been evaluated or approved by governmental regulators, such as the FDA.
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Check if there are published research articles showing that the stem cell therapy has been tested in animals or cell-based models for the intended purpose. This type of research, called a preclinical study, is required before a therapy can be tested in human clinical trials. You can search for these articles on scholarly search engines like PubMed or Google Scholar.
Common Red Flags for Unproven Cell Therapy Products
If you or a family member is ever considering treatment with a stem cell product, there are red flags you can look for to tip you off that a treatment might be unproven and unsafe:
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Patient testimonials, commonly found on unproven stem cell clinic or regenerative medicine clinic websites, are a red flag to watch for. Testimonials alone are not evidence that an intervention has received the required permission by FDA, or a similar regulator in other countries, to proceed with clinical trials.
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Check the list of conditions being studied. A true clinical trial will typically only study one or a small number of related diagnoses per treatment as a means to ensure patient safety. A clinic offering one intervention to treat a wide range of conditions at the same time may not be legitimate.
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Be extremely wary of any individual or organization that does not provide an informed consent document and give you time to thoroughly review and sign it. Every clinical trial should include a review of an informed consent form with the patient prior to enrollment, which includes information about predicted risks, possible benefits, the study design, expected length of time for participants to receive the treatment, and rights of the patients who are subjects in the study. Even common medical procedures have some risk involved, so it is a major red flag if any medical provider will not openly discuss potential treatment risks and benefits.
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Sometimes stem cell clinics will advertise directly to patients and may charge a lot of money upfront for therapies. Advertising that interventions are not covered by any kind of insurance is a warning sign.
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Be wary of stem cell clinics that are run by physicians who are not specifically trained in the disease areas that the trial is supposed to treat, or by providers who are not qualified doctors at all (qualified doctors will have an MD or DO degree). Additionally, watch out for researchers or physicians offering these kinds of procedures who are not associated with an existing reputable academic or medical institution. You can Google a researcher or clinician to find out if they work for a university or hospital and what kind of medical training they have.
To learn the answers to some frequently asked questions on unproven stem cell treatments, the International Society for Stem Cell Research has a Patient Handbook on Stem Cell Therapies you can download in multiple languages.
Explore more resources on our website about gene therapy for specific diseases, other helpful insights on the patient journey, and clinical trials information.
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