Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for Autism

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

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Key information

Conditions

Autism Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Medical Surgical Associates Center, St John's, Antigua and Barbuda

About this study

Studies have shown that stem cell treatment is safe and efficacious for the treatment of Autism. Patients with Autism will receive a single intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells. The total dose for the infusion will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Diagnosis of Autism

Exclusion criteria

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

Treatment and study plan

AlloRx

Biological

cultured allogeneic adult umbilical cord derived mesenchymal stem cells

Primary outcomes

Safety (adverse events)

Time frame: Four year follow-up

Clinical monitoring of possible adverse events or complications

Secondary outcomes

Efficacy: Autism Treatment Evaluation Checklist (ATEC)

Time frame: Four year follow-up

ATEC is a questionnaire to measure changes in severity in response to treatment. It will be completed for each follow up point.

Sponsors and collaborators

Lead sponsor

The Foundation for Orthopaedics and Regenerative Medicine

Other

Registry information

Official study title

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Autism

Important dates

Study start: 2022
Primary completion: 2027
Study completion: 2027
First posted: Aug 13, 2021
Registry last updated: Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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