Safety Issues;Effect of Drugs
Conditions
Keywords
Autism Spectrum Disorder;Autologous Umbilical Cord Blood;safety;effect
Brief summary
To study the clinical efficacy and safety of autologous umbilical cord blood transfusion in the treatment of autism spectrum disorder.
Detailed description
This is a Phase 1 clinical trial that constitutes two time points cohorts with participants who will receive intravenous autologous umbilical cord blood and 0.9% sodium chloride respectively. The timing of treatment is any time after the diagnosis of autism spectrum disorder. The investigator will proceed the groups during the same period. 1. Demographic Data and Baseline Characteristics of the Studied Group were collected: * Basic patient's information survey * Medical history * Physical examination * Basic blood test result * Autism Behavior Checklist,CARS before the treatment * Brain Magnetic Resonance Imaging-Diffusion Tensor Imaging (MRIDTI) before the treatment * Neurocognitive function test before the treatment 2. Assessment of clinical condition in the course by measurement of blood pressure, heart and respiratory rates, temperature and adverse events was recorded. 3. Autologous cord blood doses is 20-30ml (total Mononuclear cells# 1\*10\^7/kg)#the infusion speed is 1ml/min, and with same volume of 0.9% sodium chloride as placebo. 4. The follow-up: clinical test until 24th month in 3 month gaps.
Interventions
DRUG0.9% Sodium Chloride
0.9% Sodium Chloride in control group
BIOLOGICALAutologous Umbilical Cord Blood
Autologous Umbilical Cord Blood Mononuclear Cells Therapy in Autism Spectrum Disorder for safety and effect evaluation.
Sponsors
Guangdong Women and Children Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* • A patient who was diagnosed with ASD.
Exclusion criteria
* • In case a patient underwent a surgical procedure, or was administered autologous cord blood within one year before participating in a clinical trial. * Accompanied by a serious disease, such as chromosome abnormality, etc. * In case where a patient's medical condition is judged to be maladapted by a researcher. * In case a patient or his or her legal representative doesn't agree to participation in a clinical trial. * A patient having a predisposition to allergies. * A patient having serious disorders in the liver, kidney, and cardiopulmonary function.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ABC | up to 24 months after therapy at a 3-month interval | The Change of ABC score is used to assess the social and behavior function of the children who were diagnosised as ASD. |
| CARS | up to 24 months after therapy at a 3-month interval | The Change of CARS score is used to assess the social and behavior function of the children who were diagnosised as ASD. |
Countries
China
Contacts
Primary ContactHuimei Xiao, MD
Backup ContactYanqun Chang, PHD
Outcome results
None listed