Reporting Adverse Events Related to Stem Cells, Exosomes, or Other Products Marketed as Regenerative Medicine Products
Information for Patients
If you received a treatment with stem cells, exosomes, or other products marketed as regenerative medicine products, and were hurt or had a bad side effect (including new or worsening symptoms), FDA encourages you to report this to the FDA’s MedWatch Adverse Event Reporting program. To report an adverse event, click here: Report a Problem. You can fill out this form yourself or have someone fill it out for you. If you need help filling out the form, or managing the bad side effect or worsening symptoms, you may want to talk to your primary health care provider.
The most important information for you to provide in your report is:
- What kind of problem or adverse event (for example: the kind of bad side effect or worsening symptoms) you experienced and when the problem occurred
- The type and name of the product. The reporting form will ask you to identify the type of product and its name. On this form, regenerative medicine products are considered “drugs”. The name of the product can include a brand name (if there is one) or a description of the product (for example: stem cell product, exosome product, product derived from human umbilical cord blood, Wharton’s Jelly, or amniotic fluid)
- The manufacturer of the product if it was manufactured or processed by someone other than the facility or person who provided it to you (for example: the name and the location of the company that made the product).
- Whether the product was made from your cells or tissue (autologous) or made from another person’s cells or tissue (allogeneic)
- What disease or condition you have that the product was intended to treat
- When you received the treatment
- The name of the individual or individuals who gave you the treatment, and the name and location of the health care facility or clinic where you received your treatment
Even if you only have some of the above information, you should still complete a report. Fill in as much information as you can and send in the report. FDA will work with your information to try to identify the product and look further into the problems you report. We may personally contact you if we need additional information. Feel free to upload a picture of the product, or a picture of a product brochure or advertisement, that would help identify the product.
The FDA recognizes that privacy is an important concern, so you should know that we ask only for the name and contact information of the person filling out the form in case we need more information.
Your report is important and provides valuable information that FDA needs to protect patients from harmful products. Your report will become part of a database, so that FDA can consider the information you provide along with information provided by others to identify unsafe products and practices. This information can help FDA identify firms marketing unsafe products and protect other patients.
If you have questions about completing the MedWatch Form for these products or any biological products, you can contact FDA:
- Toll-free line: 1-800- 835-4709
- To report online: https://www.accessdata.fda.gov/scripts/medwatch/index.cfm