(Released 30 September 2019) The U.S. Department of Health and Human Services will support development of technology that, for the first time, could produce platelets outside the human body. If successful, the technology would improve U.S. emergency preparedness by making additional blood products available to save lives during a radiological or nuclear emergency.
Under a 2-year, $4.9 million, agreement between the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), and Platelet BioGenesis, Inc. (PBG) of Cambridge, Massachusetts, the company will develop “Human Induced Pluripotent Stem Cell Derived Platelets” or PLT+ to treat a blood condition known as thrombocytopenia.
Thrombocytopenia is a disorder in which the body has an abnormally low number of platelets, which help blood to clot. Exposure to excessive levels of radiation, such as after use of an improvised radiological device or nuclear bomb, can destroy cells that make platelets. The body will then use the remaining platelets to stop internal bleeding and will be unable to make new platelets, resulting in thrombocytopenia. Patients with severe thrombocytopenia are typically transfused repeatedly with platelets and other blood components obtained from blood donors.
“In a radiological or nuclear emergency, impacted communities will face a significant blood product shortage,” explained BARDA Director Rick Bright, Ph.D. “We are exploring donor-independent platelet technology to increase surge capacity within the blood industry. Our nation must find innovative ways to make essential blood products available to save lives in any type of mass casualty incident.”
Leveraging BARDA’s technical expertise and funding, PBG will advance the development of PLT+, including making manufacturing improvements, engaging with the FDA, and conducting a first clinical study. If the initial studies are successful, BARDA can choose to support additional clinical studies and other activities required for FDA approval.
The technology also could improve the availability of platelets. Traditionally, U.S. blood centers collect platelets from volunteer donors and sometimes struggle to distribute enough platelets and other blood products for routine medical care. By producing blood platelets in a laboratory using stem cells from human umbilical cord blood, PLT+ could provide a donor-independent source of platelets.
Improving the availability of platelets also could save lives in daily medical care, such as trauma and oncology.
PLT+ is the latest product in BARDA’s radiological and nuclear medical countermeasures portfolio. The portfolio supports development of products to combat acute radiation syndrome, which includes depletion of blood cells that can lead to severe infections, as well as injuries to internal organs and skin.
Released by the U.S. Department of Health and Human Services Assistant Secretary for Preparedness and Response (ASPR). Click here for source.