Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 2 study of Autism, sponsored by Sutter Health.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Change in language as measured by the Receptive One-Word Vocabulary Test (ROWVT-4) and Expressive One-Word Vocabulary Test (EOWVT-4) at baseline and six months following infusion of stem cells from AUCB or infusion of placebo. The ROWPVT-4 and EOWPVT-4 were administered by a neuropsychologist and are norm-referenced assessments. The ROWPVT-4 tests an individual's ability to match a spoken word with an image of an object, action, or concept. The EOWPVT-4 tests an individual's ability to name, wi
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Autologous Cord Blood Stem Cells
Study Locations (1)
California
- Sutter Pediatric Neurology - Sacramento
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2012-08 |
| Est. Completion | 2016-12 |
| Phase | Phase 2 |
What the finished NCT01638819 record still lists
NCT01638819 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 183-participant average among 104 other Autism trials with a reported enrollment target (84% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Autism
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01638819's enrollment target sits among peer trials
30 73rd of 104 higher than 29 of 104 other Autism trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Autism trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Optimizing Outcomes for Young Autistic Children
RECRUITING · Phase 2
-
The Impact of a Virtual Magic Trick Training Program
RECRUITING · Phase 2
-
Trial of Zolpidem for Sleep in Children With Autism
RECRUITING · Phase 2
-
A Study of Esomeprazole in Children With Autism
RECRUITING · Phase 2
-
Trial of Diphenhydramine for Sleep in Children With Autism
RECRUITING · Phase 2
-
Trial of Suvorexant for Sleep in Children With Autism
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00977977 · 30 participants · Phase 2
Rituximab Plus Cyclosporine in Idiopathic Membranous Nephropathy
- NCT01459107 · 30 participants · Phase 2
Human Upper Extremity Allotransplantation
- NCT01666080 · 30 participants · NA
Second or Greater Allogeneic Hematopoietic Stem Cell Transplant Using Reduced Intensity Conditioning (RIC)
- NCT01720836 · 30 participants · Phase 1
Study of the Immune Response of MUC1 (Mucin1) Peptide Vaccine for Non-small Cell Lung Cancer
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia