AURORA | Brian Freed was at the forefront of a medical revolution when he came to ClinImmune Labs in the late 1990s.
By then, the labs that launched as an entity of the University of Colorado Hospital had already started collecting cord blood through a public cord blood bank, gathering leftover blood samples taken from placentas and umbilical cords after childbirth. The field of stem cell research was still relatively new and the possibilities of cord blood as an alternative source of stem cells were still limited.
“In the early years, cord blood could only be used for children who were relatively small,” Freed said. “The way that we process cord blood, the way that we collect it — we’ve learned how to do that better, how to process and store it in a much more efficient manner.”
Freed, now the executive director of ClinImmune Labs and a professor at the University of Colorado School of Medicine, has seen profound changes to the field of cellular therapy. Those transformations continue at a rapid pace — the advances in cord blood research could end up having wide-ranging implications for conditions ranging from brain disease to heart failure.
The University of Colorado Cord Blood Bank is set to be at the forefront of those changes. A branch of ClinImmune Labs, the UCCBB recently received a license from the Food and Drug Administration as a public cord blood bank. The UCCBB’s new license is one of only two to have been approved by the FDA as part of its new licensure program.
“The FDA has been watching this field for over a decade,” Freed said, adding that the FDA had an accreditation process in place before the new license system. “They didn’t want to put in these regulations and have it stymie the field.”
Since the cord blood is not used to treat the child it came from, Freed explained, it becomes “a licensed, biological drug,” one regulated by the FDA. As the field has become more advanced in the past decade, the standards for a license have formalized.
“The process for the licensure is that they look at your facility, how you keep your records. You have to keep the same standards as any other drug manufacturer,” Freed said. “Cord blood is going into people who have their bone marrow wiped out; it’s replacing it entirely.”
Since 1996, the University of Colorado Cord Blood Bank has drawn on samples from about 17,000 women and has stored approximately 8,000 cord blood units. That blood has gone toward roughly 640 transplants in more than 150 transplant centers in more than 30 countries.
“We are pleased that as a small cord blood bank, we met this challenge and look forward to sharing our experiences with the cellular therapy community,” said UCCBB co-founder and co-medical director Ralph Quinones. “We are absolutely thrilled and excited that the FDA has licensed us and validated the last 16 years.”
According to staff from the UCCBB and ClinImmune, the new license could open the doors to new treatments and possible uses for cord blood. The center currently accepts donations from Denver Health, St. Joseph’s Hospital and other facilities.
“This may allow us to introduce other kinds of cellular therapies,” Freed said. “I think cellular therapy for cardiac disease is probably the biggest one, but there’s also possibilities for neurologic diseases, the treatment of stroke victims, connective tissue disease. I think the potential of treating them with blood-derived stem cells looks very promising.”
As one of only two facilities in the country that can boast a license from the FDA (the New York Blood Bank received its license last year), those steps may come sooner rather than later.
Reach reporter Adam Goldstein at agoldstein@aurorasentinel.com or 720-449-9707
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