Clinical Effect and Safety of Autologous Umbilical Cord Blood Transfusion in the Treatment of Autism Spectrum Disorder
- Conditions
- Safety Issues;Effect of Drugs
- Interventions
- Biological: Autologous Umbilical Cord Blood
- Registration Number
- NCT04768816
- Lead Sponsor
- Guangdong Women and Children Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 25
- • A patient who was diagnosed with ASD.
-
• 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Comparator 0.9% Sodium Chloride Placebo 0.9% sodium chloride infusion any time after entering the Placebo Group, doses is 20-30ml. The infusion speed is 1ml/min. Experimental Autologous Umbilical Cord Blood 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.
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Guangdong Women and Children's Hospital and Health Institute
🇨🇳Guangzhou, Guangdong, China