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NCT01638819 · ClinicalTrials.gov registry record · Phase 2

Autologous Cord Blood Stem Cells for Autism

A Phase 2 study of Autism, sponsored by Sutter Health.

Completed
Registry status
Phase 2
Development phase
30
Enrollment target
1
Study location

NCT01638819 is a Phase 2 study of Autism that has completed, run by Sutter Health. The registered enrollment target is 30 participants, below the 183-participant average among 104 other Autism trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01638819, a Phase 2 study of Autism, has completed, sponsored by Sutter Health.

COMPLETED
Registry status
Phase 2
Development phase
30 participants
Enrollment target
1
Study location

Study 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).

Conditions Studied

Autism

Interventions

  • BIOLOGICAL Placebo
  • BIOLOGICAL Autologous Cord Blood Stem Cells

Study Locations (1)

California

  • Sutter Pediatric Neurology - Sacramento

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2012-08
Est. Completion 2016-12
Phase Phase 2

Sponsor

Sutter Health

9 total trials

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What the Registry Record Tells You About NCT01638819

The ClinicalTrials.gov registry entry for NCT01638819 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 183-participant average among 104 other Autism trials with a reported enrollment target (84% lower). The listed sponsor is Sutter Health, which has 9 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Autism appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT01638819 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT01638819 about?

NCT01638819 is a clinical study titled "Autologous Cord Blood Stem Cells for Autism". 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...

What is the current status of trial NCT01638819?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2012-08. Estimated completion is 2016-12.

What conditions does trial NCT01638819 study?

This clinical trial studies the following conditions: Autism.

What interventions are being tested in trial NCT01638819?

The interventions under investigation include: Placebo (BIOLOGICAL), Autologous Cord Blood Stem Cells (BIOLOGICAL).

Who is sponsoring clinical trial NCT01638819?

This trial is sponsored by Sutter Health, which has 9 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01638819 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.