Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for Autism
1 other identifier
interventional
15
2 countries
3
Brief Summary
This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Autism
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jan 2022
Longer than P75 for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2021
CompletedFirst Posted
Study publicly available on registry
August 13, 2021
CompletedStudy Start
First participant enrolled
January 23, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
April 8, 2025
April 1, 2025
5.9 years
August 6, 2021
April 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety (adverse events)
Clinical monitoring of possible adverse events or complications
Four year follow-up
Secondary Outcomes (1)
Efficacy: Autism Treatment Evaluation Checklist (ATEC)
Four year follow-up
Study Arms (1)
Treatment Group
EXPERIMENTALOne intravenous infusion of 100 million cells
Interventions
cultured allogeneic adult umbilical cord derived mesenchymal stem cells
Eligibility Criteria
You may qualify if:
- Diagnosis of Autism
You may not qualify if:
- Active infection
- Active cancer
- Chronic multisystem organ failure
- Pregnancy
- Clinically significant Abnormalities on pre-treatment laboratory evaluation
- Medical condition that would (based on the opinion of the investigator) compromise patient's safety
- Previous organ transplant
- Seizure disorder
- Hypersensitivity to sulfur
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Medical Surgical Associates Center
St John's, Antigua and Barbuda
Athens Beverly Hills Medical Group
Glyfada, Athens, 16675, Greece
Mediterraneo Hospital Ilias 8-12
Glyfada, Athens, 16675, Greece
Related Publications (3)
Mahapatra S, Vyshedsky D, Martinez S, Kannel B, Braverman J, Edelson SM, Vyshedskiy A. Autism Treatment Evaluation Checklist (ATEC) Norms: A "Growth Chart" for ATEC Score Changes as a Function of Age. Children (Basel). 2018 Feb 16;5(2):25. doi: 10.3390/children5020025.
PMID: 29462954BACKGROUNDLv YT, Zhang Y, Liu M, Qiuwaxi JN, Ashwood P, Cho SC, Huan Y, Ge RC, Chen XW, Wang ZJ, Kim BJ, Hu X. Transplantation of human cord blood mononuclear cells and umbilical cord-derived mesenchymal stem cells in autism. J Transl Med. 2013 Aug 27;11:196. doi: 10.1186/1479-5876-11-196.
PMID: 23978163BACKGROUNDRiordan NH, Hincapie ML, Morales I, Fernandez G, Allen N, Leu C, Madrigal M, Paz Rodriguez J, Novarro N. Allogeneic Human Umbilical Cord Mesenchymal Stem Cells for the Treatment of Autism Spectrum Disorder in Children: Safety Profile and Effect on Cytokine Levels. Stem Cells Transl Med. 2019 Oct;8(10):1008-1016. doi: 10.1002/sctm.19-0010. Epub 2019 Jun 11.
PMID: 31187597BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chadwick Prodromos, MD
The Foundation for Orthopaedics and Regenerative Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2021
First Posted
August 13, 2021
Study Start
January 23, 2022
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
April 8, 2025
Record last verified: 2025-04