Cryo-Cell International, Inc. (symbol: CCEL), the world’s first private cord blood bank to separate and store stem cells, has entered into a collaborative license agreement with Duke University. The agreement grants Cryo-Cell the rights to proprietary processes and regulatory data related to cord blood and cord tissue developed at Duke.
MIAMI, Feb. 26, 2021 — Cryo-Cell plans to explore, test, and administer these treatments to patients with conditions for which there are limited FDA approved therapies, including cerebral palsy, autism, multiple sclerosis and COVID-19. These treatments utilize the unique immunomodulatory and potential regenerative properties derived from cord blood and cord tissue.
Under the agreement, Cryo-Cell has been granted exclusive commercial rights to Duke’s intellectual property assets, FDA regulatory data, clinical expertise and manufacturing protocols associated with various applications of cord blood and cord tissue stem cells.
Through this agreement, Cryo-Cell intends to expand to a triad of core business units:
- its renowned cord blood bank,
- biopharmaceutical manufacturing (once BLA(s) or Emergency Use Authorization(s) are approved by the FDA), and
- infusion clinic(s) services, initially under the rights granted to Duke through the FDA’s Expanded Access Program.
David Portnoy, Chairman of the Board and Co-CEO, stated, “We have tremendous respect for Dr. Joanne Kurtzberg and her scientific team at the Marcus Center for Cellular Cures at Duke University, which is internationally recognized as the leading research and clinical center using cord blood and tissue cells for immunomodulatory and regenerative medicine applications. Dr. Kurtzberg is conducting clinical trials under INDs from the FDA to treat patients for indications such as autism, cerebral palsy, adult stroke, multiple sclerosis and COVID-19.”
Mr. Portnoy continued, “This is a major step forward in our growth at Cryo-Cell, and we believe that it will be a gigantic leap forward for patients with unmet medical needs waiting for treatment. Since 2011, Cryo-Cell’s mission statement has included the goal of advancing regenerative medicine. Now, we will be able to truly fulfill our vision.”
”We are extremely excited to enter into this agreement with Cryo-Cell. It will enable us to work together to take the next steps to further develop and bring these novel therapies to patients in need.” said Joanne Kurtzberg, MD, who is the Jerome S. Harris distinguished professor of pediatrics and a pioneer in cell therapies based on umbilical cord blood. Dr. Joanne Kurtzberg is an internationally renowned expert in pediatric hematology/oncology, pediatric blood and marrow transplantation, umbilical cord blood banking and transplantation, and novel applications of cord blood in the emerging fields of cellular therapies and regenerative medicine.
As a result of this partnership with Duke University, Cryo-Cell’s Board of Directors is actively considering uplisting the Company’s common stock to a NASDAQ listing.
About Cryo-Cell International, Inc.
Founded in 1989, Cryo-Cell International, Inc. is the world’s first private cord blood bank. More than 500,000 parents from 87 countries have entrusted Cryo-Cell International with their baby’s cord blood and cord tissue stem cells. In addition to its family bank, Cryo-Cell International has a public banking program in partnership with Duke University. Cryo-Cell’s public bank has provided cord blood for more than 600 transplantations and operates cord blood donation sites across the U.S. in prominent hospitals such as Cedars–Sinai Hospital in Los Angeles and Baptist Hospital in Miami.
Cryo-Cell operates in a facility that is FDA registered, cGMP-/cGTP-compliant and licensed in all states requiring licensure. Besides being AABB accredited as a cord blood facility, Cryo-Cell was also the first U.S. (for private use only) cord blood bank to receive FACT accreditation for adhering to the most stringent cord blood quality standards set by any internationally recognized, independent accrediting organization.