]>
IRCT20200217046526N3 IRCT 2020-04-15 Tehran University of Medical Sciences Stem Cell Therapy for Autism MSCA A phase I trial evaluating the safety of 3 Times Intratechal Injection of the-MSC, an Allogenic Umbilical cord-derived Mesenchymal Stromal Cell Product, in Children with Autism Spectrum Disorder 2020-06-21 anticipated 5 Complete https://irct.ir/trial/46701 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 1 Autism Spectrum Disorder. Intervention group: 5 autistic children receiving mesenchymal cells intrathecally at one month intervals.. Yes - There is a plan to make this available What will be shared: All collected deidentified IPD can be shared When: 6 months after publication To whom: Researchers and clinicians Conditions: Planning of similar studies in other academic centers Where to obtain: eMail How to obtain: 1-2 months after request during Comments:
public Morteza Zarrabi
No. 24, East Hafez Alley., Bani Hashim Square., Bani Hashim St., Resalat Highway
Tehran Iran (Islamic Republic of) 1665666311 +98 21 2763 5512 m.zarrabi@rsct.ir Royan Stem Cell Thechnology Co scientific Mohammad Reza Mohammadi
No. 606, Karegar St., District 11
Tehran Iran (Islamic Republic of) 13337159140 +98 21 5541 9151 mohammadimr@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) 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 36 months 84 months Both 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 F84.0 Treatment - Other Intervention group: 5 autistic children receiving mesenchymal cells intrathecally at one month intervals. ََ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. 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. Royan Stem Cell Technology Co. Tehran University of Medical Sciences Royan Stem Cell Technology Co. Approved 2020-02-23 ACECR Biomedical Research Ethics Committee No. 1270, Enghelab St., Tehran., District 11., Tehran Province., Iran Tehran Tehran Iran (Islamic Republic of)