Autism Spectrum Disorder. F84.0
Conditions
Interventions
Intervention group: 5 autistic children receiving mesenchymal cells intrathecally at one month intervals..
Sponsors
Tehran University of Medical Sciences
Royan Stem Cell Technology Co.
Eligibility
Sex/Gender
All
Age
36 Months to 84 Months
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ??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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMorteza Zarrabi
Royan Stem Cell Thechnology Co
Outcome results
None listed