drugset / Trial / NCT02176317
Autologous Umbilical Cord Blood Infusion for Children With Autism Spectrum Disorder (ASD)
Phase 1
Completed
25 enrolled
Duke University
Perkin Elmer Inc. · collabThe Marcus Foundation · collab
NaSingle-groupOpen-labelTreatment
Summary
This study is a prospective phase 1 single-center trial designed to determine the safety of a single intravenous infusion of autologous umbilical cord blood in children with Autism Spectrum Disorder (ASD) and assess the feasibility of various outcome measures to determine which measure(s) can be used as primary and secondary endpoints for a future randomized phase 2 clinical trial. All subjects will receive infusion of cord blood cells at baseline with follow up assessments at 6 and 12 months.
Timeline
- Start
- 2014-06
- Primary completion
- 2015-12
- Completion
- 2015-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Autologous cord blood | Cell therapy | 1e+07 cells/kg | Intravenous |
| Subject | Autologous cord blood | Cell therapy | 5e+07 cells/kg | Intravenous |