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 more about our Autism program, please visit the Duke Center for Autism and Brain Development website.

Currently Enrolling

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, aging 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.

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 mesencymal stromal cells (hCT-MSC), administered in children with autism spectrum disorder (ASD).

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

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, aging 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 6 months, with remote follow up at 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, autism 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.

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.

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

A Study of UCB and MSCs in Children With CP: ACCeNT-CP (ACCeNT-CP)

The main purpose of this study is to estimate change in motor function 12 months after treatment with a single dose of allogeneic umbilical cord blood (AlloCB) or repeated doses of umbilical cord tissue-derived mesenchymal stromal cells (hCT-MSC) in children with cerebral palsy. Children ages 2-5 years with cerebral palsy due to hypoxic ischemic encephalopathy, stroke, or periventricular leukomalacia may be eligible to participate. All participants will ultimately be treated with an allogeneic cell product at some point during the study.

hCT-MSCs for Children with Autism Spectrum Disorder

This study is a phase I, prospective, open-label trial designed to assess the safety of one, two, and three intravenous doses of hCT-MSC in young children with ASD. Children ages two to 11 years with ASD will be eligible to participate.

Assessment of the Safety of Allogeneic Umbilical Cord Blood Infusions in Children with Cerebral Palsy

This study is a single site, phase I, prospective study of the safety of intravenous sibling cord blood infusion in 15 children ages 1-6 years with Cerebral Palsy (CP). All subjects will be treated with sibling cord blood cells.

Cord Blood Infusion for Children with Autism Spectrum (Duke ACT)

This is a single site, prospective, randomized, double-blind study of a single intravenous autologous or allogeneic, unrelated cord blood (CB) infusion in children ages 2-7 years with Autism Spectrum Disorder (ASD). All participants will ultimately be treated with CB cells at some point during the study. Participants with an available qualified autologous CB unit will receive autologous cells, and those without a suitable autologous CB unit available will receive cells from a ≥4/6 HLA-matched, ABO-matched allogeneic, unrelated donor CB unit from the Carolinas Cord Blood Bank.