A journey that began in Gainesville, Fla. more than 15 years ago, that’s allowed newborn babies to become lifesavers, reached a milestone Thursday, when the Food and Drug Administration notified LifeSouth that its license was approved for cord blood manufacturing.
LifeCord, which is a program of LifeSouth, became only the fifth public cord blood bank in the country to receive its FDA license, and the first in Florida, Georgia and Alabama where it currently operates. LifeSouth CEO Nancy Eckert said the rigorous application and approval process was difficult but she’s proud of the accomplishment.
“A lot of people have worked very hard and for a very long time to meet the rigorous licensing requirements of the FDA,” Eckert said. “Cord blood is at the forefront of progressive medical treatments and I’m proud that LifeSouth will continue to be a leader in transfusion medicine and patient care.”
Umbilical cord blood contains the stem cells that can be used by patients needing marrow transplants for the treatment of leukemia and other serious diseases. Dr. John Wingard, LifeCord’s medical director, and a physician at UF Health in Gainesville, first proposed starting a public cord blood bank in North Florida in 1996.
“This is a huge milestone along the journey we’ve traveled, but it’s not the destination. The destination is providing a transplant to everyone who needs a cure,” Wingard said. “Receiving the license indicates we are meeting the highest and most stringent standards for providing high quality products to the patients we serve.”
LifeSouth joins cord blood banks in New York, St. Louis, Duke University and the University of Colorado in receiving a license. Wingard said the milestone is also an example of how the cooperative effort of the University of Florida, UF Health and a community organization, like LifeSouth, can work together to promote health.
“I’m very proud of the very hard work,” Wingard said. “The LifeCord staff has demonstrated a passion for this, and they are tirelessly working to provide a needed service for our community.”
When the LifeCord program began in 1998, it was licensed under an investigative new drug protocol.
“The FDA recognized this is no longer an investigation, it has become part of medical practice and needed higher standards to assure quality and ethical standards for patients,” Wingard said.
LifeSouth submitted its application for its FDA license in May of 2012, and has undergone numerous reviews of its facilities, procedures, equipment and staff qualifications.
As a physician, Wingard said he’s seen the use of cord blood for transplants grow over the past 15 years. Originally seen as a treatment that might only be suitable for children, procedures were developed to also allow it to work successfully with adults. LifeSouth has provided 109 units for transplant to 23 different states and nine foreign countries.
“It’s particularly helpful for minority groups where we often struggle to find matches,” he said.
The reason, he explained, is that immune systems of the newborns are more naïve and more flexible.
“With cord blood we have more flexibility, we can tolerate some mismatches,” he said. “Hundreds of individuals each year would not have been cured without cord blood because there were no other transplant options available.”
LifeSouth currently collects cord blood donations at eight hospitals in Florida, Georgia and Alabama. Wingard encourages parents to donate, saying it’s safe for mother and baby, and there is no additional cost.
“The birth of a baby is a joyous occasion,” he said. “The gift of the cord extends that joy to another family by giving another child a chance for life.