SPECIALTY TOPICS · GUIDE
Product Quality in Emerging Interventions
What product quality means for cell, gene and exosome products, what U.S. rules and FDA reports say about contamination and identity, and the questions to ask before any such treatment.
Content last updated . This page has not been medically reviewed.
Back to Emerging Wellness ScienceIf you feel seriously ill after any injection or procedure
Get medical help right away. In the United States, call 911. Tell clinicians what product was used and where. The FDA lists life-threatening blood infections among the safety concerns with illegally marketed regenerative products. [1] Then see adverse-event reporting for emerging products.What "product quality" means
For a pill from a pharmacy, quality can feel like a given. For a product made from living cells, tissue or genetic material, quality has more parts to check, and a product that is handled or screened poorly can carry germs, as the FDA material below describes. This page covers the concept and what official sources say. It does not describe how any product is made, and it is not a guide to choosing one.The FDA's guidance on chemistry, manufacturing and control (CMC) information for human gene therapy investigational new drug applications (January 2020) says its purpose is to help sponsors provide information that assures product safety, identity, quality, purity and strength, including potency. [2] Those words are a useful checklist. The plain-language meanings in the table are our own glosses, not FDA text:
| Term | Plain meaning |
|---|---|
| Identity | Is it what the label says it is? |
| Purity | Is anything unwanted in it, such as germs? |
| Potency | Does it have the biological activity it is supposed to have? |
| Strength | How much active material does it contain? |
| Safety and quality | Was it made under controls that prevent harm? |
What U.S. rules require of cell and tissue products
Under FDA rules for human cells, tissues and cellular and tissue-based products (HCT/Ps), manufacturers must follow current good tissue practice requirements. These aim to prevent the introduction, transmission or spread of communicable diseases, for example by ensuring products do not contain disease agents, are not contaminated and do not become contaminated during manufacturing. [3] The rules cover facilities, environmental control, equipment, supplies and reagents, recovery, processing, labeling, storage and distribution. [3]Before a clinical investigation of an investigational new drug begins, a sponsor must have an Investigational New Drug (IND) application in effect. [4] That is how FDA oversight of a trial starts.
What FDA reports describe when oversight is missing
The FDA says unapproved regenerative medicine products, including stem cells, stromal vascular fraction, umbilical cord blood products, amniotic fluid, Wharton's jelly, orthobiologics and exosomes, require FDA licensure or approval to be marketed to consumers. [1] Its list of safety concerns includes cross-contamination with bacteria, viruses or mold related to processing, and products not being tested for infectious diseases such as hepatitis and HIV. [1] It also lists bacterial infections, unwanted immune responses, and cells moving to another part of the body and forming tumors. [1]In its December 6, 2019 notice, the FDA reported multiple serious adverse events in patients in Nebraska treated with unapproved products marketed as containing exosomes, and stated there were no FDA-approved exosome products at that time. [5] Check the FDA's current pages for later changes.
The FDA's 2024 page also states that, at that time, the only FDA-approved stem cell products in the United States were blood-forming stem cells derived from umbilical cord blood, and only for disorders affecting the production of blood. [1]
Quality questions that come from the sources
- Has the FDA reviewed the treatment? Can the provider give an IND number and the FDA communication acknowledging it? [5]
- Is the product offered inside a trial with an Institutional Review Board and a consent form? [5]
- Can the study sponsor provide the clinical investigator's brochure, which describes the product and its safety and effectiveness? [5]
- Is there a test report for infectious disease? The FDA lists a lack of such testing as a safety concern. [1]
A "yes" from a provider does not replace an official record. A clinic offering something does not establish approval. See regulatory status of regenerative products.
Treatments abroad
The FDA says it does not have oversight of treatments done in other countries and typically has little information about foreign establishments or their products. [5]Related guides
Product contamination and route-specific risks, cell therapy safety, extracellular vesicles and exosomes and product quality and contamination in natural remedies.Frequently asked questions
Are stem cell or exosome treatments sold at clinics FDA-approved?
In the United States, the FDA says the only approved stem cell products are cord-blood-derived blood-forming cells for blood-production disorders, and that unapproved regenerative products require approval or trial oversight. [1] The FDA stated in 2019 that no exosome products were approved; check current FDA pages. [5]
What can go wrong with a poorly made cell product?
The FDA lists infections, immune reactions, tumor formation and blindness among the concerns for illegally marketed products. [1]
Does a lab certificate prove quality?
We did not find an official source saying a certificate alone proves quality. A useful question is what was measured, by whom, and whether the FDA has reviewed the product. The FDA's CMC description names identity, quality, purity, strength and potency as what manufacturing information must assure. [2]
Does being on ClinicalTrials.gov mean the product is approved or safe?
No. The FDA says listing on ClinicalTrials.gov does not mean a product is legally marketed. [1]
References
- U.S. Food and Drug Administration. Important Patient and Consumer Information About Regenerative Medicine Therapies. Posted June 3, 2021; content current as of 04/08/2024. Read 2026-10-22.
- U.S. Food and Drug Administration. Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs) (guidance, January 2020). Read 2026-10-22.
- U.S. Code of Federal Regulations, Title 21, Section 1271.150. Current good tissue practice requirements. eCFR. Read 2026-10-22.
- U.S. Code of Federal Regulations, Title 21, Section 312.20. Requirement for an IND. eCFR. Read 2026-10-22.
- U.S. Food and Drug Administration. Public Safety Notification on Exosome Products. December 6, 2019. Read 2026-10-22.