Past Research Studies
The AIMS Study
AIMS study researchers are evaluating a new cellular therapy and its potential to improve social abilities in adults diagnosed with autism. Participants receive a diagnostic evaluation and compensation. We are no longer enrolling participants in this study.
The IMPACT Study
This randomized clinical trial is evaluating a new cell therapy and its effect on social and communication skills in autistic children, ages 4-11 years. We are no longer enrolling participants in this study.
The aViation Study
The aViation study tested if an investigational study drug could improve the social communication and interaction skills of 5-to-17 year olds with "high-functioning" autism. The investigational study drug blocks a hormone receptor in the brain that is linked to the control of socialization, stress, anxiety, and aggression. This study was sponsored by F. Hoffman-La Roche Ltd and completed in 2017. Pro00073627
Efficacy of Umbilical Cord Blood Infusion for Improving Outcomes of Children with Autism Spectrum Disorder: DukeACT
Researchers at Duke University Medical Center conducted this program of research to evaluate the efficacy of autologous and allogeneic cord blood for improving outcomes of children with autism spectrum disorder. This study investigated whether a single intravenous infusion of umbilical cord blood can improve autism symptoms in children with autism spectrum disorder through a randomized, placebo controlled, Phase II clinical trial. This program of research was sponsored by the Marcus Foundation and was completed in 2016. Pro00070514
Understanding Children’s Social Development
This study was conducted at five universities throughout the US, including Duke, Harvard, Yale, UCLA, and University of Washington with the goal to learn more about social development in children diagnosed with autism and those who were not diagnosed with autism. The study aimed to find ways to better design clinical trials that help autistic children improve their social skills. This study was sponsored by the National Institutes of Health. Pro00065628
The Effects of Oxytocin in the Brain
This study investigated the effects of oxytocin, an investigational medication, and its effects on the brain. Specifically this research studied the effects of oxytocin vs. placebo on various brain activities that relate to social behaviors. This study was sponsored by the National Institute of Mental Health. Pro00042504
blüm: The Study of a Biological Autism Medication
This study focused on an investigational drug, CM-AT, an enzyme that is sprinkled over food that aims to improve digestion of protein and reduce harmful gut/brain interactions and therefore may improve symptoms associated with autism. Researchers investigated whether the study drug helped to improve symptoms such as irritability. This study was sponsored by Curemark, LLC. Pro00064746
Study of Oxytocin in Autism Reciprocal Social Behaviors (SOARS-B)
The study evaluated the investigational medication oxytocin, which is thought to improve social functioning in autistic individuals. The goal of the study was to evaluate oxytocin as a supplemental treatment for improving social skills in autistic individuals ages 3 - 17. This study was sponsored by Eunice Kennedy Shriver Institute for Child Health and Human Development. Pro00063950
Sensory Processing and Anxiety in Preschool Age Children with and without Autism Spectrum Disorder
The goal of this study was to conduct an in-depth study of the relationship between sensory over-responsivity and anxiety symptoms in preschool age children, using parent report, observation, and brain-based measures (brain waves or EEG). Our goals were to (1) understand the relationship between sensory processing, anxiety symptoms, tummy symptoms, and parental stress using a combination of parent report, observational, and brain based measures, and (2) explore new methods that could potentially improve our ability to assess sensory processing, attention, and anxiety in young children. This study was sponsored by the Department of Defense Autism Research Program and a Brain and Behavior Foundation NARSAD Young Investigator Award. Pro00053510
Clinical Trial to Evaluate the Efficacy of Umbilical Cord Blood to Improve Outcomes for Children with Autism Spectrum Disorder
This study evaluated the efficacy of autologous and allogeneic cord blood for improving outcomes of individuals with autism spectrum disorder. The first study examined the safety and efficacy of using autologous cord blood to treat young children diagnosed with autism spectrum disorder and assessed the feasibility of various outcome measures to determine which measures can be used as primary and secondary endpoints for a randomized phase 2 clinical trial (DukeACT). Previous research has shown that cord blood cells can help reduce inflammation and signal cells to help repair damaged brain areas. The goal of this study was to investigate whether similar success would be shown in autistic children. The results of this study have been published in Stem Cells Translational Medicine. You can view the publication here. This program of research was sponsored by the Marcus Foundation. Pro00052449