NCT02847182

Cord Blood Infusion for Children With Autism Spectrum Disorder

Efficacy of Intravenous Umbilical Cord Blood Infusion as Cell Therapy for Children With Autism Spectrum Disorder (ASD): Duke ACT

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Joanne Kurtzberg, MD · Academic / Other
• Sex: All
• Age: 2 Years – 7 Years
• Healthy volunteers: Not accepted

Summary

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). Participants will be randomly assigned to Sequence A, consisting of a single infusion of CB cells at baseline followed 6 months later by a single infusion of placebo, or Sequence B, consisting of an infusion of placebo at baseline followed 6 months later by an infusion of CB cells. 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. All infusions will be double-blinded. The primary outcomes will be assessed 6 months after the initial infusion in the sequence. Additional testing for secondary exploratory analyses will be performed at 12 months. Duration of study participation will be 12 months from the time of baseline infusion.

Conditions

• Autism Spectrum Disorder
• ASD
• Autism
• PDD

Interventions

Type	Name	Description
BIOLOGICAL	Cord Blood Infusion
BIOLOGICAL	Placebo

Timeline

• Start date: 2016-09-01
• Primary completion: 2018-08-19
• Completion: 2019-05-01
• First posted: 2016-07-28
• Last updated: 2020-06-09
• Results posted: 2019-12-26

Locations

1 site across 1 country: United States