Advancing the Science

Currently, cord blood is approved for the treatment of 80 diseases. Additionally, the stem cells derived from umbilical cord blood and cord tissue have shown promising results in ongoing trials as investigational therapy to treat a wide range of other conditions. Each year, new therapies using stem cells from cord blood and cord tissue enter into clinical trials for the treatment of chronic and life-threatening diseases such as autism, cerebral palsy, multiple sclerosis, traumatic brain injury, stroke, and many others. With FDA-approval, these treatments can then be administered as a general practice.

Under a licensing agreement with Duke University, 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 explore, test, and administer these treatments to patients with conditions for which there are limited FDA approved therapies.

Exciting Research Developments




Video provided courtesy of Save The Cord Foundation - a 501c3 nonprofit and host of World Cord Blood Day



 
In this video, Dr. Joanne Kurtzberg, Director of the Marcus Center for Cellular Cures at Duke University and Cryo-Cell’s Medical Director, offers an overview of the progress made in several clinical trials in which she is involved.

Since 2017, the Expanded Access Program operated under the Marcus Center for Cellular Cures at Duke University has opened the door for hundreds of patients to receive access to treatment for neurological conditions such as autism, cerebral palsy, stroke, and others using umbilical cord blood and cord tissue.

In addition, Dr. Kurtzberg reviews her work with the manufacturing of three types of therapeutic cells: cord blood, cord tissue mesenchymal stem cells (MSCs), and DUOC (cells manufactured from cord blood). These manufactured cells from the listed sources above are being explored in the treatment of conditions such as chronic brain injury, cerebral palsy, stroke, graft vs. host disease, autism spectrum disorder, COVID-acute respiratory disease (ARDS), hypoxic-ischemic encephalopathy, osteoarthritis, leukodystrophies, and multiple sclerosis.

The results of these clinical trials give us better insight into the direction of future research for patients in need of care. Cryo-Cell's vision is to move from Phase III clinical trials and Expanded Access to licensed biological products that will deliver approved therapies for a wide range of conditions.

human body with cord blood treatments Currently, cord blood stem cells have been approved by the FDA in the treatment of nearly 80 diseases. In addition to these approved therapies, there are close to 350 clinical trials underway investigating the use of umbilical cord blood and umbilical cord tissue for stem cell transplantation, and this number promises to steadily increase. Cord blood stem cells are approved for numerous types of malignancies, anemias, inherited metabolic disorders and deficiencies of the immune system. The majority of cord blood transplants to date have been performed in patients younger than 18 years; however, advancements in regenerative medicine show promise for all ages. See all the diseases currently being treated.

Current trials show promise for cord blood in the treatment of strokes, heart disease, diabetes and more. Umbilical cord–derived stem cells, meanwhile, are undergoing clinical trials for the treatment of multiple sclerosis, sports-related injuries, and various neurodegenerative diseases including ALS (also known as Lou Gehrig’s disease) and Alzheimer’s.

Through an exclusive licensing agreement, Dr. Joanne Kurtzberg and her scientific team at the Marcus Center for Cellular Cures at Duke University will be conducting ongoing clinical trials under an FDA-approved IND to treat patients for indications such as autism, cerebral palsy, and other brain injuries; with the intent of administering these treatments at a clinic location(s) managed by Cryo-Cell. We believe that this collaborative license agreement will provide greater opportunity for patients with unmet medical needs waiting for treatment.

 
Cord blood and cord tissue stem cells are currently undergoing clinical trials for a variety of diseases including ones once thought untreatable:
 

  Read more about the benefits of cord blood and cord tissue.