Trials / Unknown
UnknownNCT04768816
Clinical Effect and Safety of Autologous Umbilical Cord Blood Transfusion in the Treatment of Autism Spectrum Disorder
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- Sponsor
- Guangdong Women and Children Hospital · Academic / Other
- Sex
- All
- Age
- 2 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 0.9% Sodium Chloride | 0.9% Sodium Chloride in control group |
| BIOLOGICAL | Autologous Umbilical Cord Blood | Autologous Umbilical Cord Blood Mononuclear Cells Therapy in Autism Spectrum Disorder for safety and effect evaluation. |
Timeline
- Start date
- 2019-07-01
- Primary completion
- 2022-12-31
- Completion
- 2024-12-31
- First posted
- 2021-02-24
- Last updated
- 2021-02-24
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04768816. Inclusion in this directory is not an endorsement.