Current Trials

Thank you for your interest in our clinical trials. Here you can find a list of our current clinical trials. Please click on the name of the trial to find out more about it on clinicaltrials.gov. If you are interested in participating in any of these trials, please contact us at cordbloodtherapyinfo@dm.duke.edu.

If 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

Currently Enrolling

Intrathecal Administration of DUOC-01 in Adults With Primary Progressive Multiple Sclerosis

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). DUOC-01 cells are manufactured from donated human umbilical cord blood and are intended for treatment of neurodegenerative and demyelinating diseases. 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. At 2 weeks post administration there will be a virtual visit to evaluate for adverse events. 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.

hCT-MSC in Adults With Autism Spectrum Disorder (AIMs)

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. This study will be enrolling adults with ASD 18 to 35 years of age.

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. On-site assessments will be conducted at baseline, and remote study visits will occur at 6 months and 1 year.

Expanded Access Protocol: Umbilical Cord Blood Infusions for Patients with Brain Injuries

The primary purpose of this protocol is to enable access to sibling or autologous umbilical cord blood for children with various brain disorders. 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. Patients with qualifying partially or fully matched sibling or autologous cord blood units will be eligible.

Umbilical Cord Blood (UCB) Transplant of Inherited Metabolic Diseases with Administration of Intrathecal UCB Derived Oligodendrocyte-Like Cells (DUOC-01)

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). The secondary objective of the study is to describe the efficacy of UCBT with intrathecal administration of DUOC-01 in these patients.

Active, not recruiting

hCT-MSC in Children with Autism Spectrum Disorder (IMPACT)

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).

This is a study in children with ASD 4 to 11 years of age. Qualifying subjects undergo neuropsychological evaluation, EEG testing, eye tracking, CVA assessments, and infusion of study product. Subjects are randomized to the order in which they receive hCT-MSC and placebo infusions.

Update:  As of January 19, 2023, enrollment in the IMPACT trial is complete.  Treatment and data collection from participants who are currently enrolled on the study will continue through the end of 2023.  Results of the study are expected to be released during the summer of 2024.

hCT-MSC in Toddlers With Autism Spectrum Disorder (TACT)

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 toddlers with Autism. This study will be enrolling children with ASD 18 months to 3 years of age.

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. On-site assessments will be conducted at baseline and 6 months, with remote follow up at 1 year.

Study of Allogeneic Umbilical Cord Blood Infusion for Adults with Ischemic Stroke (CoBIS2)

The primary objective of this study is to determine the efficacy of a single intravenous infusion of unrelated donor umbilical cord blood (UCB) for improving functional outcomes in patients with ischemic stroke. Eligible subjects will receive an intravenous infusion of UCB or placebo 3-10 days following stroke.