CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Autologous Cord Blood Stem Cells +1 morebiological
Likely dose
Autologous Cord Blood Stem Cells 60 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01638819
NCT01638819Phase 2Completed
CompareCT.gov

A Randomized, Blinded, Placebo-controlled, Crossover Study to Assess the Efficacy of Stem Cells From Autologous Umbilical Cord Blood to Improve Language and Behavior in Children With Autism

Sutter Health·interventional·Posted Jul 12, 2012·Updated Aug 20, 2018

In Brief

A Phase 2 clinical trial evaluating Autologous Cord Blood Stem Cells and Placebo for Autism. Completed, enrolled 30 participants across 1 site.

Detailed Summary

Evaluate the efficacy of one infusion of stem cells from autologous umbilical cord blood in patients with autism over six months after infusion as measured by changes in expressive and receptive language. Also demonstrate improved behavior, learning, and changes in Serum tumor necrosis factor alpha (TNF-α), tumor necrosis factor beta (TNF-β), interleukin 1-alpha (IL-1α), interleukin 1-beta (IL-1β), interleukin 6 (IL-6), interleukin 10 (IL-10), and interleukin 13 (IL-13).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAutism
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 12, 2012
Enrollment StartAug 1, 2012
Primary CompletionDec 1, 2015
Study CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 14.0 years ago

Interventions

Autologous Cord Blood Stem Cellsbiological

One infusion of 60 ml syringe of study product

Placebobiological

Saline