The St. Louis Cord Blood Bank at SSM Cardinal Glennon Children’s Medical Center has received licensure approval from the U.S. Food and Drug Administration to manufacture and distribute cord blood-derived stem cell products, making it the first bank in the region and only the fourth in the world to earn this distinction.
The FDA’s biologic licensure application is a rigorous process to ensure that public cord blood banks adhere to the highest quality manufacturing practices and safety standards. The St. Louis Cord Blood Bank submitted its application October 2011 and, during the subsequent 18 months, hosted site visits and frequent dialogue with the FDA while continuing routine operations.
“With this recognition from the FDA, patients and their physicians can be assured that we have met every requirement to produce the highest quality cord blood products and provide life-saving treatment in the safest way possible,” said Donna Regan, director of the St. Louis Cord Blood Bank.
Cord blood, a non-controversial source of stem cells found in the umbilical cord after the routine delivery of newborn babies, can be used to treat more than 70 diseases, including leukemia and lymphoma. Formerly regarded as an investigational new drug, the FDA now classifies and regulates cord blood stem cell products used for these treatments as biologic drugs.
“Cord blood differs from pharmaceutical drugs in that each collected unit has its own unique biologic features,” Regan said. “Our team is responsible for manufacturing each cord blood product in a sterile environment while preserving the integrity of the cells that provide critical healing and treatment for very ill children and adults.”
Expectant mothers register to be cord blood donors during pregnancy. Cord blood donation is a safe and painless process that occurs in the hospital shortly after delivery. Since its inception in 1996, more than 130,000 families in this community have donated their baby’s umbilical cord blood to the St. Louis Cord Blood Bank.
Products in the St. Louis Cord Blood Bank inventory are listed on the Be the Match® registry, where physicians can search for units that are matched to their patients. Once identified, matched cord blood units can be shipped to patients anywhere around the world. Of the 35,000 cord blood transplants performed globally, the St. Louis Cord Blood Bank has provided nearly 7 percent of all transplants occurring worldwide.
As one of the first licensed cord blood banks in the world, the St. Louis Cord Blood Bank can help guide the future of cord blood cells and advocate for greater awareness of the benefits of this little-known solution to many diseases.
“As we begin to understand more about cord blood and work together as an industry to determine how it’s regulated, the ways we can help people in need of transplant will only increase,” Regan said. “We are grateful to be involved in the discussion and have the opportunity to provide greater insight to broadening therapeutic applications of these valuable cells.”
For more information about cord blood and its benefits, visit slcbb.org.