![]() Some parents have received partial reimbursement of these costs through the Family Support Program for Pediatric Transplant and Cellular Therapies at Duke, and occasionally from their health insurance plan 2,3. The parents have also paid Duke to cover the costs of delivering the off-trial therapy 2. The parents of these children supply cord blood that they paid to store in private banks when their child was born. Since October 2017, the off-trial treatment has been operating in accordance with an FDA-approved Expanded Access Program (EAP) that allows children to receive infusions with their own cord blood or cord blood from a sibling. Once the FDA began to regulate cord blood therapy as a biologic drug, all of Duke’s therapy programs have operated under Investigational New Drug (IND) approvals from the FDA. Prior to 2010, the FDA did not have any regulations on banking or therapies with cord blood 1. In addition to their trials, Duke has also offered off-trial therapy of cord blood stem cell infusions to children with neurodevelopmental disorders. During this time, Duke has enrolled hundreds of children into 19 clinical trials using cells from cord blood or from cord tissue as therapy for neurodevelopmental disorders. Questions can be directed to Verter, PhDįor 17 years, parents from all over the world have traveled to Duke University Medical Center (Duke hereafter) to seek stem cell therapy for their child that has cerebral palsy, or autism, or one of several other neurodevelopmental disorders. The Foundation's Terms of Use is expressly incorporated herein. The Foundation is not liable for any damages of any kind, nature or description (whether direct, consequential or punitive) arising out of or relating to information referenced in the Newsletter, or related in any way to the user's access to the Newsletter. Access to and use of all Newsletter information is at the user's own risk. The Foundation reserves the right at any time to remove materials and information from the Newsletter without communication with the author or organization. ![]() The Foundation is not responsible for the accuracy and completeness of information provided by guest authors, outside sources, or on websites linked to the Newsletter. The materials and information included in this electronic newsletter (Newsletter), including advertisements, are provided as a service to you and do not reflect endorsement by the Parent's Guide to Cord Blood Foundation (the "Foundation"). ![]()
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