FDA grants South Texas Blood & Tissue Center first license for new process that triples shelf life of critically needed platelets


Breakthrough expected to increase availability of platelets for treating cancer patients and active bleeding cases

SAN ANTONIO, Texas – The U.S. Food and Drug Administration has granted the South Texas Blood & Tissue Center (STBTC) a license to use a new process shown to almost triple the current five-day shelf life of platelets.

Platelets are a key blood component constantly in demand for treating trauma, severely bleeding patients and maternal hemorrhage, which is a special challenge for rural hospitals. There also is a growing need for platelets for use in cancer treatment, transplant surgeries and other medical conditions.

STBTC, a subsidiary of BioBridge Global, is the first blood center in the United States to receive an FDA license to produce the licensed cold-stored platelets. Cold-stored platelets are refrigerated and can be transfused up to 14 days after collection.

Under current practices, platelets are stored at room temperature and have a short shelf life of five 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.

“We believe this breakthrough new process will increase availability of platelets and reduce expirations – in short, save more lives,” said STBTC Chief Operating Officer Elizabeth Waltman. “This is especially significant in light of continuing platelet shortages across the country. It also helps to keep platelets available to rural critical access hospitals so they can treat maternal hemorrhage and traumatic injury.”

STBTC serves hospitals and clinics in 48 Texas counties, covering thousands of square miles.

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. 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.

Platelets also are critical to cancer treatments. Of all the platelets transfused in the United States in a typical year, more than 20% go to cancer patients undergoing chemotherapy, and the demand is growing. In 2009, the American Society of Clinical Oncology projected that cancer diagnoses through 2030 would increase by 45% from 2010.

Public, private and military collaborators, as well as medical device manufacturers, have worked on the discovery and development of the new process.

The U.S. military and other researchers who are part of the THOR (Trauma Hemostatis & Oxygenation Research) group brought the process to light. The Mayo Clinic in Rochester, Minnesota, was the first hospital to produce and transfuse three-day cold stored platelets. Last year, the military received an FDA variance to produce 14-day cold-stored platelets. 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. “We expect to begin providing cold-stored platelets to hospital partners within the next few months.”

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.

About the South Texas Blood & Tissue Center:

The South Texas Blood & Tissue Center (STBTC) is a nonprofit community blood center that provides blood, plasma, platelets and other blood components to 100 hospitals in 48 South Texas counties. It is the largest blood supplier in our region. STBTC has a 45-year history serving the South Texas community. It is part of the BioBridge Global family of nonprofit organizations, while offers services in regenerative medicine and research including blood banking and resource management; cellular therapy; umbilical cord blood collection and storage; donated human tissue recovery and distribution for transplant; and testing of blood and plasma products to help patients in the United States and worldwide. STBTC has seven donor rooms in South Texas and conducts hundreds of mobile blood drives each year. STBTC is online at SouthTexasBlood.org