Stem Cell Therapy for Autism
- Conditions
- Autism Spectrum Disorder.F84.0
- Registration Number
- IRCT20200217046526N3
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 5
Confirmed clinical DSM-5 diagnosis of Autism Spectrum Disorder using the DSM-5 Checklist with level 2
Parental consent
Stable on current psychiatric medication regimen (dose and dosing schedule) for at least 2 months prior to infusion of study product
Review of medical records indicates Autism diagnosis not likely
Presence of any concomitant systemic disease (active infection, any malignancy,...), Central Nervous System Infection, people with Nervous System Inflammation, Cerebral palsy
Presence of any psychiatric disorders such as Asperger's syndrome, Depression, Bipolar disorder, Schizophrenia, Tourette's syndrome
History of major surgery in the last 30 days
History of allogeneic tissue transplantation
History of active seizure disorder over the past 6 months
History of a primary immunodeficiency disorder, HIV
Records indicate that the child has a known genetic syndrome related to Autism
History of allergic disease
Participate in other clinical trial studies
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ??Adverse events assesment. Timepoint: ?At the time of each injection, 24 hours after each injection, 7-10 days after each injection, 3 month after the final injection. Method of measurement: Common Terminology Criteria for Adverse Events (CTCAE) Version 4.
- Secondary Outcome Measures
Name Time Method Change in Childhood Autism Rating Scale, CARS. Timepoint: Before injection, 7-10 days after each injection, 3 months after the final injection. Method of measurement: Childhood Autism Rating Scale form.;Change in Autism Treatment Evaluation Checklist. Timepoint: Before injection, 7-10 days after each injection, 3 months after the final injection. Method of measurement: Autism Treatment Evaluation Checklist.;Change in the Behavior Problems Inventory. Timepoint: Before injection, 7-10 days after each injection, 3 months after the final injection. Method of measurement: The Behavior Problems Inventory Checklist.;Change in Electroencephalogram. Timepoint: Before injection, 7-10 days after each injection, 3 months after the final injection. Method of measurement: Change in EEG waves.;Assess the quality of life base on Short-form 36. Timepoint: Before injection, 7-10 days after each injection, 3 months after the final injection. Method of measurement: SF 36 questionnaire.