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. This agreement will enable Cryo-Cell to develop cord blood and cord tissue therapies for children and adults with a variety of diseases that currently have limited to no available treatments. Cryo-Cell also plans to open clinics where patients can receive these treatments on clinical trials or as part of an expanded access protocol before they are approved by the FDA as standard treatments*.
Leveraging the Duke agreement, Cryo-Cell plans to explore, test, and administer umbilical cord blood and cord tissue derived stem cell therapy treatments to patients with conditions for which there are limited FDA-approved therapies, including cerebral palsy, autism, 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 at Duke over the past 2 decades. Cryo-Cell intends to bring novel cord blood and cord tissue-based cellular therapies to FDA approvals and treatments in the clinic. This is predicted to expand the treatment opportunities for patients with the intent of administering treatments at Cryo-Cell’s 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 may benefit from access to treatment in Expanded Access protocols, which will be conducted concurrently with ongoing clinical trials under INDs from the FDA to treat patients for indications such as autism, cerebral palsy, and other brain injuries*.
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.
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.
* - Patients do not have to be customers of Cryo-Cell’s cord blood and cord tissue banking services to have access to treatment.