Autism
Conditions
Keywords
Autism, stem cell treatment
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.
Interventions
BIOLOGICALAlloRx
cultured allogeneic adult umbilical cord derived mesenchymal stem cells
Sponsors
The Foundation for Orthopaedics and Regenerative Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety (adverse events) | Four year follow-up | Clinical monitoring of possible adverse events or complications |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Antigua and Barbuda, Greece
Outcome results
None listed