FDA Launches Investigation Into Potentially Toxic Nanoparticles Used In Blood Products

About 20% of patients who receive blood products suffer moderate to severe side effects, according to the FDA

Federal drug regulators have launched a research program to evaluate the effects of biological and engineered nanoparticles used in blood and blood products, to better understand the potential side effects they may pose for patients.

The blood nanoparticles research program, headed by Jan Simak, Ph.D., was  announced by the Food and Drug Administration (FDA) in a press release on March 4, focusing on microscopic vesicles naturally occurring in the blood and on nanoparticles engineered for blood and other blood products, like blood cells, platelets, endothelial cells and others.

The FDA hopes that by conducting the research, the agency can better understand how these natural and engineered nanoparticles can play a role in negative side effects posed to patients during blood transfusions.

Blood naturally contains microscopic phospholipid vesicles, referred to as extracellular vesicles (EVs). Counts of the EVs increase during processing and storage of blood and blood products. These can pose a risk to patients when blood is administered, including the risk of abnormal clotting, stimulation of inflammation, and prothrombotic effects.

Moderate to severe side effects are documented in roughly 20% of patients who receive blood or blood products.

More than 90% of EVs are smaller than 100 nanometers, tens of thousands of times smaller than the width of a human hair, too small for analysis using conventional methods. Thus, specialized microscopic research must be done, and the FDA is also includes working to develop high resolution analysis and imaging on a nano scale.

The research will include a focus on determining the toxicity of engineered nanoparticles. Different types of nanoparticles are used in blood products, including during collecting, processing, and storage. FDA researchers will also investigate the effects of nano materials on platelets and cells. Additionally, they will investigate nanoparticles as cryoprotectants for platelet cold storage and cryopreservation.

Overall, the research is dedicated to ensuring EVs and nanoparticles are safe and effective to use on patients and which characteristics make them toxic to blood cells and blood vessels.