Clinical Effect and Safety of Autologous Umbilical Cord Blood Transfusion in the Treatment of Autism Spectrum Disorder
Overview
- Phase
- Phase 1
- Intervention
- 0.9% Sodium Chloride
- Conditions
- Safety Issues;Effect of Drugs
- Sponsor
- Guangdong Women and Children Hospital
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- ABC
- Status
- Recruiting
- Last Updated
- 5 years ago
Overview
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.
Investigators
Xiao Huimei
Dr
Guangdong Women and Children Hospital
Eligibility Criteria
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.
Arms & Interventions
Placebo Comparator
Placebo 0.9% sodium chloride infusion any time after entering the Placebo Group, doses is 20-30ml. The infusion speed is 1ml/min.
Intervention: 0.9% Sodium Chloride
Experimental
Autologous Umbilical Cord Blood Mononuclear Cells Therapy any time after the diagnosis of cerebral palsy, doses is 20-30ml (total Mononuclear cells#1\*10\^7/kg). The infusion speed is 1ml/min.
Intervention: Autologous Umbilical Cord Blood
Outcomes
Primary Outcomes
ABC
Time Frame: 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
Time Frame: 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.