Platelet products are transfused to manage uncontrolled or life-threatening bleeding due to trauma, thrombocytopenia, or platelet disorders. Despite today’s medical advancements, there are still challenges to treating bleeding patients with standard platelets.
Platelets are transfused in the United States every 17 seconds to treat or prevent bleeding.
What are Platelets?
Platelets, also known as thrombocytes, are small cellular components of blood that are made in the bone marrow. They are critical in maintaining the integrity of the body's entire vascular system and stopping bleeding. When an injury causes bleeding, platelets rush to the site of injury, adhering to the damaged blood vessel to form a clot.
Research has shown these powerful cells also have potential uses in innate immunity, targeted drug delivery, and regenerative medicine.
Challenges to Treating Bleeding with Standard Platelets
Standard platelets are slow to stop bleeding. They lose some of their capability to stop bleeding while stored and need to circulate in the patient about 24 hours to fully restore their hemostatic capability. There is also variability between donors, meaning the clinical effect in patients will vary. There are some thrombocytopenic patients (10 to 14%) whose bleeding does not stop with platelet transfusion because they have become refractory and standard platelets do not work for them.
The platelets used to make Thrombosomes become activated as a result of the manufacturing process, potentially stopping bleeding faster. Cellphire’s Thrombosomes manufacturing process overcomes the individual variability of donor platelets, by pooling platelets from up to 10 donors, leading to a very consistent product. This could prove effective in treating refractory patients.
There are bacterial and viral contamination risks associated with standard platelet products.
Cellphire incorporates a pathogen reduction step in manufacturing Thrombosomes, which ensures a high level of safety. The 3-year shelf life allows us to perform confirmatory testing for bacteria and endotoxins prior to release further reducing risk, allowing for a safer product.
Once donated, platelets have a very short shelf life (5 to 7 days) leading to a limited supply in most hospitals. Many hospitals, up to 30 percent, do not have routine access to platelets or rarely have them available. Seasonal and regional blood supply shortages occur regularly, disrupting platelet supplies and patient care. Other events such as natural disasters and pandemics can significantly reduce supplies.
Thrombosomes could be immediately available at all hospitals and all levels of care—from first responders to the operating room—because they can be stored at room temperature for 3 years and are easy to use.
Platelets are only routinely available in some hospitals. Research has shown that early treatment of traumatic bleeding with platelets within minutes of arrival to the hospital saves lives. Today, first responders and medics in the battlefield don’t have ready access to lifesaving platelets because, along with their short shelf life, they can’t be easily stored or transported.
The long shelf life and ease of use of Thrombosomes highly simplifies the logistics of the product. It could allow us to supply Thrombosomes to all hospitals, and once approved, for prehospital use to air and ground ambulances and combat medics.