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NCT02847182 · ClinicalTrials.gov registry record · Phase 2
Cord Blood Infusion for Children With Autism Spectrum Disorder
A Phase 2 study of Autism Spectrum Disorder and Autism, sponsored by Joanne Kurtzberg, MD.
- Completed
- Registry status
- Phase 2
- Development phase
- 180
- Enrollment target
- 1
- Study location
NCT02847182 is a Phase 2 study of Autism Spectrum Disorder and Autism that has completed, run by Joanne Kurtzberg, MD. The registered enrollment target is 180 participants, above the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (33% higher). The trial reports 1 study location across 1 state.
The verdict
NCT02847182, a Phase 2 study of Autism Spectrum Disorder and Autism, has completed, sponsored by Joanne Kurtzberg, MD.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 180 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Cord Blood Infusion
Study Locations (1)
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2016-09 |
| Est. Completion | 2019-05 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02847182
The ClinicalTrials.gov registry entry for NCT02847182 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (33% higher). The listed sponsor is Joanne Kurtzberg, MD, which has 15 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02847182 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT02847182 about?
NCT02847182 is a clinical study titled "Cord Blood Infusion for Children With Autism Spectrum Disorder". 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 infusio...
What is the current status of trial NCT02847182?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 180 participants. The study started on 2016-09. Estimated completion is 2019-05.
What conditions does trial NCT02847182 study?
This clinical trial studies the following conditions: Autism Spectrum Disorder, Autism, ASD, PDD.
What interventions are being tested in trial NCT02847182?
The interventions under investigation include: Placebo (BIOLOGICAL), Cord Blood Infusion (BIOLOGICAL).
Who is sponsoring clinical trial NCT02847182?
This trial is sponsored by Joanne Kurtzberg, MD, which has 15 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02847182 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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