It has recently been announced that the Duke University Medical Center has received permission, from the FDA, to expand the access of cord blood clinical trials for conditions like autism spectrum disorder and cerebral palsy. Children who have these neurological disorders are now able to receive therapy, regardless of whether they qualify for a targeted clinical trial.
In order to be considered for the FDA’s expedited access program, the new therapy “must treat a serious condition that has substantial impact of day-to-day function”, and there must be an “unmet medical need because the condition is not addressed adequately by therapeutic alternatives.”
In the United States, 1 in 323 children have been identified with Cerebral Palsy, and 1 in 68 children have been identified with autism spectrum disorder, and worldwide, there are projected to be tens of thousands of children who are eligible for the new extended access program.
In order to participate in the new clinical trial, patients must have their own or a sibling’s cord blood preserved in a family bank.