Access to Innovative Treatments
Cryo-Cell International, Inc., has entered into an exclusive 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. Cryo-Cell is the only cord blood bank that has the right to offer treatments to children at its own infusion clinic under Duke’s FDA-approved Investigational New Drug Application (IND). Currently, Cryo-Cell expects to open its first clinic by January 2022.
Under this agreement, Cryo-Cell plans to explore, test, and administer umbilical-cord derived stem cell treatments to patients with conditions for which there are limited FDA-approved therapies, including cerebral palsy
, and other neurological conditions
. These treatments utilize the unique immunomodulatory and potential regenerative properties derived from cord blood and cord tissue.
What Does This Mean?
This licensing agreement will advance the work of Dr. Joanne Kurtzberg and her colleagues with the intention of bringing novel cord blood and cord tissue-based cellular therapies to the clinic. In turn, this is predicted to expand the treatment opportunities for patients under the FDA’s Expanded Access Program
; with the intent of administering treatment at a Cryo-Cell stem cell infusion clinic (or clinics). 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.
“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.”
-David Portnoy, Chairman of the Board and Co-CEO
Extended Benefits for Patients
Patients can benefit from access to treatment in clinical trials, which are currently under FDA-approved INDs to treat patients for indications such as autism, cerebral palsy, and other brain injuries.
The same access to treatments currently offered to patients under Duke’s FDA Expanded Access Program (EAP) will also be available within one of our anticipated clinic locations. Since 2017, the Expanded Access Program has enabled hundreds of families who have stored their children’s cord blood to take advantage of investigational therapies offered at The Marcus Center for Cellular Cures at Duke University. Children with various brain disorders, such as autism, apraxia, cerebral palsy, hydrocephalus, hypoxic brain injury, and stroke, are eligible to participate.
However, the demand for those therapies continues to overwhelm the limited capacity available, and there is a waitlist several months-long. These experimental treatments call for stringent selection criteria, including the number of cells required for a child's infusion per body weight. Since children grow quickly, it is critically important to provide access to therapy before the child outgrows the number of cells available for the treatment. Licensing of Duke's EAP treatment protocols allows Cryo-Cell to offer the same high-quality care they come to expect from an FDA-approved program at a forthcoming, new clinic location.
Mutually Invested Interest
We are dedicated to aiding the advancement of regenerative medicine. Dr. Joanne Kurtzberg is a pioneer in cellular therapies using umbilical cord blood. Dr. Kurtzberg and her scientific team at The Marcus Center for Cellular Cures at Duke University are recognized as the leading research and clinical center using cord blood and cord tissue cells for immunomodulatory and regenerative medicine applications.
Dr. Joanne Kurtzberg is a world 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. Dr. Kurtzberg also serves as Medical Director at Cryo-Cell International to oversee all laboratory processes and procedures.
The Cryo-Cell Difference
Cryo-Cell operates its own state-of-the-art processing, testing and cryopreservation operation with FACT accreditation. We are in complete control of every step, ensuring the highest quality available today.
Our laboratory operates in accordance with the guidelines set forth by our Medical and Scientific Advisory Board. In the Cryo-Cell laboratory, only qualified technologists handle specimens. Specimens are individually processed using either one of the two processing methods, HESPAN or PrepaCyte-CB, to maximize the recovery of stem cells.
Our dedication to providing clients with the premier cord blood and cord tissue cryopreservation service and, ultimately, cord blood infusion will revolutionize the treatment outcome for families in need.
We make cord blood and cord tissue stem cell preservation accessible and affordable for every expectant parent by offering flexible payment options and special offers.
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