FDA grants South Texas Blood & Tissue Center a supplement to its biologics license for cold-stored platelets with 14-day storage period
The U.S. Food and Drug Administration has granted the South Texas Blood & Tissue Center (STBTC) approval to manufacture and distribute cold-stored platelets with a shelf life of 14 days for the treatment of actively bleeding patients when conventional platelets are not available, or their use is not practical.
Platelets are a key blood component constantly in demand for treating severe bleeding, for example in trauma and maternal hemorrhage patients.
STBTC, a subsidiary of BioBridge Global, is the first civilian blood center in the United States to receive a supplemental approval to produce cold-stored platelets for use in treating actively bleeding patients through day 14 of storage when conventional platelet products are unavailable, or their use is not practical.
Under current practices, platelets are stored at room temperature and have a shelf life of five or seven days, with the first 48 hours of that time typically required for testing and distribution to hospitals. With this new process, platelets are refrigerated within two hours of collection, which extends their viability to 14 days for the treatment of actively bleeding patients when conventional platelets are not available, or their use is not practical. The cold-stored platelets manufactured under this process are intended only to treat bleeding, and are not indicated to prevent bleeding in patients with low platelet counts, such as cancer patients.
“We believe this new process will increase availability of platelets for the treatment of actively bleeding patients when conventional platelets are not available or their use is not practical.” said STBTC Chief Operating Officer Elizabeth Waltman. “It also helps to keep platelets available to rural critical access hospitals so they can treat actively bleeding patients when conventional platelet products are unavailable, or their use is not practical.”
STBTC serves hospitals and clinics in 48 Texas counties, covering thousands of square miles.
Platelets are the blood component that begins the process of healing a break in blood vessels and often are transfused in cases of extreme bleeding. For example, hemorrhage is the single largest cause of pregnancy/delivery deaths in the United States, according to statistics compiled by the Centers for Disease Control and Prevention.
Public, private and military collaborators, as well as medical device manufacturers, continue to study the use of cold stored platelets.
The U.S. military and other researchers who are part of the THOR (Trauma Hemostasis & Oxygenation Research) group brought the process to light. The Mayo Clinic in Rochester, Minnesota, has also produced and transfused cold stored platelets stored for up to three days for the treatment of actively bleeding patients. Last year, the military received an FDA variance to produce 14-day cold-stored platelets for the treatment of actively bleeding patients when conventional platelets are not available, or their use is not practical. The STBTC licensed 14-day cold-stored platelets are approved for collection on the Trima Accel Automated Blood Collection System from Terumo BCT.
“Without the vision and assistance of all our collaborators, we would not have been able to achieve this transfusion medicine milestone,” Waltman said. “Within the next few months we expect to begin providing cold-stored platelets for actively bleeding patients when we are not able to meet such orders with conventional platelets .”
Donors are critical to making sure there are enough platelets and other blood components available for patients, she said.
“The growing need for platelets, combined with more regular blood shortages across the U.S., means we can’t bring the benefit of these breakthroughs to the hospitals we serve without more donors,” Waltman said.