The U.S. Food and Drug Administration (FDA) is preparing to conduct research examining how cannabinoids including delta-9 THC and CBD affect human placental cells, according to a federal contracting notice.
The FDA issued a solicitation recently seeking primary human trophoblast cells for researchers at the agency’s National Center for Toxicological Research (NCTR) in Jefferson, Arkansas.
Trophoblast cells are specialized cells involved in formation and function of the placenta. In the solicitation, FDA describes primary human trophoblast cells as the “gold standard” for laboratory-based placental toxicity testing.
“The current study aims to investigate how cannabinoids, including Δ9-tetrahydrocannabinol (Δ9-THC) and cannabidiol (CBD), affect human placental cells,” the agency states in the contracting document.
FDA says the cells will serve as a primary laboratory model for evaluating cannabinoid-induced toxicity. Researchers also plan to use them to establish three-dimensional cultures, which the agency says provide a more physiologically relevant system for studying drug-induced placental toxicity.
The agency is seeking 20 vials of plateable, cryopreserved primary human trophoblast cells from individual female donors, with each vial containing at least 1 million viable cells.
FDA requires post-thaw cell viability above 80%. Once plated, the cells must be capable of forming a confluent layer with distinct nuclei and tight cellular junctions for at least three days. The supplier must also characterize the cells to confirm trophoblast-specific features and provide donor demographic information and, when available, cause of death.
The research is being conducted through NCTR’s Division of Biochemical Toxicology, which conducts laboratory research designed to improve understanding of the biological effects and potential toxicity of substances regulated by FDA.
The solicitation does not disclose the specific cannabinoid concentrations researchers plan to test, whether cannabinoids other than THC and CBD will be included, or when results from the study could become available.
Work is slated for FDA’s National Center for Toxicological Research campus in Jefferson, Arkansas. The solicitation required submitted pricing to remain firm through September 30.
As of September 21, the federal procurement listing does not show an award for the contract.
