Protocol summary
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Study aim
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To determine the efficacy and safety of treatment with autologous bone marrow stem cells compared with the routine treatment of children with ASD
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Design
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The present parallel, single-blind, and randomized clinical trial was conducted on the ASD children referred to the Pediatric Clinic at Ibn-e-Sina Hospital and Establishments covered by the Social Welfare Organization, including the Charity and Rehabilitation Centers and Exceptional Education Centers in Mashhad, Iran
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Settings and conduct
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The present parallel, single-blind, and randomized clinical trial was conducted on the ASD children referred to the Pediatric Clinic at Ibn-e-Sina Hospital and Establishments covered by the Social Welfare Organization, including the Charity and Rehabilitation Centers and Exceptional Education Centers in Mashhad, Iran
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Participants/Inclusion and exclusion criteria
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The inclusion criteria: the age range of ≥5 and ≤15 years and diagnosis of ASD. 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.
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Intervention groups
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This parallel, single-blind, and randomized clinical trial was conducted on ASD children aged 5-15 years old . The patients were randomly assigned to one of the case group (intervention with MSC plus rehabilitation therapy) or the control group (rehabilitation therapy alone).
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Main outcome variables
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of CARS total score, GARS-II, Autism Index, Global improvement, and CGI-S
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201512315280N22
Registration date:
2016-05-28, 1395/03/08
Registration timing:
retrospective
Last update:
2018-09-28, 1397/07/06
Update count:
1
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Registration date
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2016-05-28, 1395/03/08
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Vice chancellor for research, Mashhad University of Medical Sciences
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Expected recruitment start date
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2015-04-04, 1394/01/15
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Expected recruitment end date
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2015-08-23, 1394/06/01
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Actual recruitment start date
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2015-04-21, 1394/02/01
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Actual recruitment end date
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2015-08-30, 1394/06/08
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Trial completion date
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2016-08-29, 1395/06/08
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Scientific title
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Efficacy and Safety of Augmenting Autologous Bone Marrow Stem Cell Therapy in Routine Treatment of Children with Autism Spectrum Disorder: A Randomized Clinical Trial
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Public title
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Efficacy Stem Cell in Treatment Autism
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
age range of ≥5 and ≤15 years
a definite diagnosis of ASD based on DSM
Exclusion criteria:
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
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Age
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From 5 years old to 15 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
36
Actual sample size reached:
32
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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This single-blind trial was conducted in such a way that only the psychologist assessing the status of children was unaware of interventions.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2015-02-18, 1393/11/29
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Ethics committee reference number
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930960
Health conditions studied
1
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Description of health condition studied
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Autism
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ICD-10 code
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F84.0
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ICD-10 code description
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Childhood autism
Primary outcomes
1
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Description
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Autism
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Timepoint
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Baseline, 1, 3, 12 months
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Method of measurement
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GARSII test
2
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Description
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Autism
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Timepoint
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Baseline, 1, 3, 12 months
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Method of measurement
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CARS test
3
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Description
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Illness severity
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Timepoint
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Baseline, 1, 3, 12 months
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Method of measurement
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Clinical Global Impression (CGI)
Intervention groups
1
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Description
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In intervention group stem cell intratechal transplantation is doing augmentation of usual treatment.
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Category
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Treatment - Surgery
2
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Description
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In control group Patients get routine treatment .
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mashhad University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable