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NCT05003960 Clinical Trial

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

Autism Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05003960
Other study ID # SC-8-ATG-8-02
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date January 23, 2022
Est. completion date December 1, 2027

Study information
Verified date November 2023
Source The Foundation for Orthopaedics and Regenerative Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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. For patients with more severe disease an autologous Effector cells (activated lymphocytes) treatment will be utilized created from the patient's own cells obtained by apheresis.

Recruitment information / eligibility
Status Recruiting
Enrollment 15
Est. completion date December 1, 2027
Est. primary completion date December 1, 2027
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Biological:
• AlloRx
cultured allogeneic adult umbilical cord derived mesenchymal stem cells

Locations
Country Name City State
Antigua and Barbuda Medical Surgical Associates Center St. John's
Greece Athens Beverly Hills Medical Group Glyfáda Athens
Greece Mediterraneo Hospital Ilias 8-12 Glyfáda Athens

Sponsors (1)
Lead Sponsor Collaborator
The Foundation for Orthopaedics and Regenerative Medicine

Countries where clinical trial is conducted

Antigua and Barbuda,  Greece, 

References & Publications (3)

Lv 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. — View Citation

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. — View Citation

Riordan 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Safety (adverse events) Clinical monitoring of possible adverse events or complications Four year follow-up
Secondary Efficacy: Autism Treatment Evaluation Checklist (ATEC) ATEC is a questionnaire to measure changes in severity in response to treatment. It will be completed for each follow up point. Four year follow-up
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