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IRCT201512315280N22 IRCT 2016-05-28 Mashhad University of Medical Sciences Efficacy Stem Cell in Treatment Autism Efficacy and Safety of Augmenting Autologous Bone Marrow Stem Cell Therapy in Routine Treatment of Children with Autism Spectrum Disorder: A Randomized Clinical Trial 2015-04-04 anticipated 36 Complete https://irct.ir/trial/5647 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The random allocation of patients was done using the numbered, sealed and stapled envelopes. To hide the allocation, random numbers were created using the https://www.random.org/ site and placed by one of the colleagues outside the research team inside the paper envelopes. After explaining the study objectives to the parents of the eligible patients, an envelope was taken for the individual and then, based on the envelope contents, the person was enrolled in the case group receiving SCs and the rehabilitation treatment or in the control group receiving rehabilitation therapy alone, Blinding description: This single-blind trial was conducted in such a way that only the psychologist assessing the status of children was unaware of interventions. N/A Autism. Intervention 1: In intervention group stem cell intratechal transplantation is doing augmentation of usual treatment. Intervention 2: In control group Patients get routine treatment . Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is The decision will be made after discussing all authors.
public Dr Narges Sharifzadeh
Ibn-e-Sina Hospital, Bu-Ali Sq., Amel Blvd., Mashhad,Iran.
Mashhad Iran (Islamic Republic of) 345 - 91357 +98 51 3711 2701 narges.sharifzadeh@gmail.com Mashhad University of Medical Sciences scientific Dr Mohammad reza Fayyazi bordbar
Ibn-e-Sina Hospital, Bu-Ali Sq., Amel Blvd., Mashhad,Iran.
Mashhad Iran (Islamic Republic of) 345 - 91357 +98 51 3711 2540 narges.sharifzadeh@gmail.com Mashhad University of Medical Sciences Iran (Islamic Republic of) age range of ≥5 and ≤15 years a definite diagnosis of ASD based on DSM 5 years 15 years Both a long history of allergic reactions seizures during the past six months brain trauma moderate to severe extrapyramidal symptoms and tardive dyskinesia severe self-injury behavior autoimmune diseases severe hematologic and pulmonary disease (such as pneumonia, asthma, malignancy and immune deficiency) severe focal or systemic infection (such as AIDS, hepatitis and syphilis) kidney and liver problems anemia and hemoglobin level less than 8 g/dL bone marrow- associated diseases receiving other treatments affecting the health of stem cell therapy F84.0 Childhood autism Treatment - Surgery Treatment - Drugs In intervention group stem cell intratechal transplantation is doing augmentation of usual treatment. In control group Patients get routine treatment . Autism. Timepoint: Baseline, 1, 3, 12 months. Method of measurement: GARSII test. Autism. Timepoint: Baseline, 1, 3, 12 months. Method of measurement: CARS test. Illness severity. Timepoint: Baseline, 1, 3, 12 months. Method of measurement: Clinical Global Impression (CGI). Mashhad University of Medical Sciences Approved 2015-02-18 Ethics Committee of Mashhad University of Medical sciences Administration Center(Qoreishi Building), Daneshgah St., Mashhad, Iran. Mashhad Razavi Khorasan Iran (Islamic Republic of)