South Texas Blood & Tissue Center joins FDA program to develop potential COVID-19 treatment; therapy based on antibodies in plasma from recovered patients
The South Texas Blood & Tissue Center, a subsidiary of San Antonio-based BioBridge Global, is participating in a U.S. Food and Drug Administration (FDA) investigational program for U.S. blood centers to begin collecting and distributing convalescent plasma from individuals who have recovered from COVID-19.
While COVID-19 currently has no proven treatment, it is possible that convalescent plasma, which contains antibodies to the virus that causes COVID-19, may provide passive immunity to certain patients with severe forms of the illness. Plasma is the liquid component of the bloodstream, and it includes the disease-fighting antibodies that a body produces in response to an infection.
The South Texas Blood & Tissue Center is one of only a handful of centers that will have the ability to test the collected plasma to determine the concentration of antibodies in each unit, thanks to a partnership between BioBridge Global and Austin-based XBiotech to develop a clinical test to identify natural antibodies against the virus present in human blood. BioBridge Global subsidiary QualTex Laboratories will handle testing of plasma for the program.
“The FDA has expedited the process for blood centers to begin this program,” said Elizabeth Waltman, Chief Operating Officer of the South Texas Blood & Tissue. “We are working with our partners at XBiotech and at area hospitals to finalize our procedures and hope to begin collecting from eligible donors as early as next week.
“We expect that many donors who have experienced COVID-19 will want to do their part to help patients suffering from a severe form of the illness,” Waltman said. “We ask that donors remain patient as we work to put the program into place.”
Individuals may be eligible to donate convalescent plasma if they were confirmed with a prior diagnosis for COVID-19 by a laboratory test and are completely free of symptoms of infection. Recovered patients who meet this criteria along with all FDA requirements for blood donation can learn more about participating by emailing COVID19@southtexasblood.org.
Plasma collection from recovered COVID-19 patients will not take place at a current STBTC donor room. A dedicated blood collection team is being created to work with patients donating convalescent plasma.
STBTC also will provide blood samples to XBiotech to enable the development of a candidate True Human antibody therapy for the disease.
The South Texas Blood & Tissue Center will make the tested plasma available to the network of hospitals it serves, Waltman said. “Our medical directors will work with hospital physicians to make the plasma available to patients through a formal process approved by the FDA.”
COVID-19 convalescent plasma can only be donated by someone who is otherwise eligible to donate blood. Donors must present identification. Those age 16 must have a signed parental consent form and weigh at least 120 pounds. Donors age 17 or older must weigh at least 110 pounds. All donors are asked to eat well and adequately hydrate before and after donation.
The AABB, an international nonprofit association that focuses on transfusion medicine and cellular therapy, issued guidelines for the process earlier this week. The treatment uses blood products taken from people who have recovered from a viral infection and transfuses them into those still infected.
The FDA frequently asked questions about convalescent plasma can be found here.