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

Phase 1

Recruiting

• Conditions: Autism
• Interventions: Biological: AlloRx

• Registration Number: NCT05003960
• Lead Sponsor: The Foundation for Orthopaedics and Regenerative Medicine

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2021-08-06
• Study First Submitted QC: 2021-08-06
• Study First Posted: 2021-08-13
• Study Start: 2022-01-23
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-04
• Last Update Posted: 2025-04-08
• Primary Completion: 2027-12-01
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Group	AlloRx	One intravenous infusion of 100 million cells

Primary Outcome Measures

Name	Time	Method
Safety (adverse events)	Four year follow-up	Clinical monitoring of possible adverse events or complications

Secondary Outcome Measures

Name	Time	Method
Efficacy: Autism Treatment Evaluation Checklist (ATEC)	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.

Trial Locations

Locations (3)

Mediterraneo Hospital Ilias 8-12; 🇬🇷 Glyfáda, Athens, Greece

Medical Surgical Associates Center; 🇦🇬 St. John's, Antigua and Barbuda

Athens Beverly Hills Medical Group; 🇬🇷 Glyfáda, Athens, Greece