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 blood 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 in 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.
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 the St. Louis community have donated 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. The St. Louis Cord Blood Bank has provided nearly 7 percent of all 35,000 cord-blood transplants performed globally.
Umbilical-cord blood currently is being used to treat malignant bone marrow diseases such as leukemia and lymphoma, as well as congenital disorders such as Fanconi’s anemia, Wiskott Aldrich syndrome and Severe Combined Immune Deficiency (the boy in the bubble syndrome). Non-malignant diseases such as Severe Aplastic Anemia, thalassemia and sickle-cell anemia are also benefiting from therapies using cord blood. Unlike other treatments for sickle cell anemia, cord blood offers a cure.
“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.”
Information for this story was provided by the St. Louis Cord Blood Bank.
Stem cells and ethics
What’s the difference between stem cells from cord blood and from an embryo?
Cord blood — an ethical source of stem cells found in the umbilical cord after the routine delivery of newborn babies, it can be used to treat more than 70 diseases, including leukemia and lymphoma. Cord-blood stem cells are considered adult stem cells, as they are obtained from a developed individual and no one is harmed in the process of obtaining them. Stem cells from cord blood have been accepted as a treatment option for many
diseases. The Catholic Church is not opposed to stem cells obtained from adult tissue, bone marrow, muscle, fat, nerves and similar sources
Embryonic stem cells — derived from fertilized human eggs, their use is against Church teaching. The Church opposes embryonic stem-cell research because harvesting these stem cells kills the living human embryo.
St. Louis Cord Blood Bank
• Established in 1995, the community-based cord blood bank at SSM Cardinal Glennon Children’s
Medical Center collects, processes and stores umbilical cord blood for the purpose of clinical cures and basic research in the field of stem-cell transplantation.
• One of the largest and most active public cord-blood banks in the world, the St. Louis Cord Blood Bank program includes community and donor education, cord-blood collection, processing in its laboratory, release of the cord-blood product and evaluation of transplant outcomes.