Update: As of January 19, 2023, enrollment in the IMPACT trial is complete. Subjects are randomized to the order in which they receive hCT-MSC and placebo infusions. Qualifying subjects undergo neuropsychological evaluation, EEG testing, eye tracking, CVA assessments, and infusion of study product. This is a study in children with ASD 4 to 11 years of age. The purpose of this double blinded Phase II study is to determine the efficacy of human umbilical cord tissue-derived mesenchymal stromal cells (hCT-MSC), administered in children with autism spectrum disorder (ASD). hCT-MSC in Children with Autism Spectrum Disorder (IMPACT) On-site assessments will be conducted at baseline, and remote study visits will occur at 6 months and 1 year. HCT-MSCs are cells manufactured from umbilical cord tissue that was donated at the delivery of a healthy baby, and may decrease inflammation in the body. This study will be enrolling adults with ASD 18 to 35 years of age. This is a phase I clinical trial being done at Duke Hospital testing the safety of a single intravenous infusion of human umbilical cord tissue derived mesenchymal stromal cells (hCT-MSC) in adults with Autism. Active, not recruiting hCT-MSC in Adults With Autism Spectrum Disorder (AIMs) The secondary objective of the study is to describe the efficacy of UCBT with intrathecal administration of DUOC-01 in these patients. The primary objective of the study is to determine the safety and feasibility of intrathecal administration of DUOC-01 as an adjunctive therapy in patients with inborn errors of metabolism who have evidence of early demyelinating disease in the central nervous system (CNS) who are undergoing standard treatment with unrelated umbilical cord blood transplantation (UCBT). Umbilical Cord Blood (UCB) Transplant of Inherited Metabolic Diseases with Administration of Intrathecal UCB Derived Oligodendrocyte-Like Cells (DUOC-01) Patients with qualifying partially or fully matched sibling or autologous cord blood units will be eligible. Patients up to age 26 with cerebral palsy, hydrocephalus, hypoxic brain injury, stroke, apraxia and other brain injuries will be eligible if they do not qualify for or are unable to participate in another active clinical trial at Duke. The primary purpose of this protocol is to enable access to sibling or autologous umbilical cord blood for children with various brain disorders. Expanded Access Protocol: Umbilical Cord Blood Infusions for Patients with Brain Injuries Follow up visits at Duke will involve physical and neurological exams, functional evaluations, questionnaires, blood tests, and brain MRI at 3, 6 and 12 months. At 2 weeks post administration there will be a virtual visit to evaluate for adverse events. Participants will be admitted to the hospital and undergo a lumbar puncture (insertion of a needle into the lower back) for injection of the cells into the spinal fluid and will then remain in the hospital for 24-hours of observation. DUOC-01 cells are manufactured from donated human umbilical cord blood and are intended for treatment of neurodegenerative and demyelinating diseases. The purpose of this open label Phase I study is to assess the safety and potential efficacy of DUOC-01 cells in adults with Primary Progressive Multiple Sclerosis (PPMS). Currently Enrolling Intrathecal Administration of DUOC-01 in Adults With Primary Progressive Multiple Sclerosis If you are interested in participating in any of these trials, please contact us at you are interested in learning about other autism research opportunities unrelated to cell therapy at Duke, please visit the Duke Center for Autism and Brain Development. Please click on the name of the trial to find out more about it on. Here you can find a list of our current clinical trials. Thank you for your interest in our clinical trials.
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