Objectives: The objective of this study was to assess the affect of treatment with Autologous bone marrow stem cell in autism. Design: This study is a randomized, double blind, case–control study. Setting and conduct: 36 autism patients will be allocated in two groups (18 patients in cases and 18 patients in control group). They will get routine treatment in control group and stem cell transplantation will be done in cases group. Major inclusion and exclusion criteria: children between 5_15 years of age who are met DSM V criteria for diagnosis of Autism Spectrum Disease (ASD), are enrolled and if any serious side effect occurs during treatment or other underlying disease will be excluded.Intervention: After receiving the inform consent from parents, Clinical Global Impression (CGI), The Childhood Autism Rating Scale (CARS), Gilliam Autism Rating Scale (GARS-II) tests will be done. Next, bone marrow aspiration will be done . sample of 50cc of iliac crest will be supplied and will be sent to research center in order to take mesenchymal stem cell . The first intratechal injection will be done.The quality control will be done for the extracted cells And after 4 weeks , mesenchymal cells injection will be done with the method of the first injection . In the third month the tests will be completed. The above named tests will be repeated in 6th and 12th months after starting the treatment .Main outcome measures: The severity of autism criteria will be evaluated during the treatment with these tests.The results will help us to prove the efficacy stem cell injection in the treatment of autism.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201512315280N22
Registration date:2016-05-28, 1395/03/08
Registration timing:retrospective
Last update:
Update count:1
Registration date
2016-05-28, 1395/03/08
Registrant information
Name
Raheleh Nejati
Name of organization / entity
Mashhad University of Medical Scinces, Ibn-e- Sina Psychiatric Hospital
Country
Iran (Islamic Republic of)
Phone
+98 51 3711 2540
Email address
nejatir2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Expected recruitment start date
2015-04-04, 1394/01/15
Expected recruitment end date
2015-08-23, 1394/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial on augmentation of Autologous bone marrow
stem cell therapy compared to the usual treatment in autistic children
Public title
A clinical trial on augmentation of Autologous bone marrow stem cell therapy compared to the usual treatment in autistic children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: They are children between the ages of 5-15 years old that patient’s parents and their legally authorized representative provided informed consent; they were met DSM V criteria for diagnosis of ASD; the diagnosis was confirmed by a two pediatric psychiatrist based on structured interview.
Exclusion criteria: Any serious side effect during treatment " Long history of allergic reaction" history of seizure for at least 6 month prior to the beginning of the study; Head trauma; Moderate to severe extra pyramidal syndrome or tardier dyskinesia; Self mutilative behavioral; autoimmune disease" Sever hematologic or lung diseases e.g. Asthma or malignancy, immune deficiency" Sever focal and systemic infection e.g. (HIV, hepatitis, Syphilis) "Renal or liver diseases" Sever anemia with hemoglobin fewer than 8" Bone marrow related diseases" Other treatments that may affect the efficacy and safety of stem cell therapy" Resign of the patient to cooperate at any time.
Age
From 5 years old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical sciences