Clinical Effect and Safety of Autologous Umbilical Cord Blood Transfusion in the Treatment of Autism Spectrum Disorder
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|ClinicalTrials.gov Identifier: NCT04768816|
Recruitment Status : Recruiting
First Posted : February 24, 2021
Last Update Posted : February 24, 2021
|Condition or disease||Intervention/treatment||Phase|
|Safety Issues;Effect of Drugs||Drug: 0.9% Sodium Chloride Biological: Autologous Umbilical Cord Blood||Phase 1|
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.
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
- Assessment of clinical condition in the course by measurement of blood pressure, heart and respiratory rates, temperature and adverse events was recorded.
- 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.
- The follow-up: clinical test until 24th month in 3 month gaps.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Clinical Effect and Safety of Autologous Umbilical Cord Blood Transfusion in the Treatment of Autism Spectrum Disorder|
|Actual Study Start Date :||July 1, 2019|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2024|
Placebo Comparator: 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.
Drug: 0.9% Sodium Chloride
0.9% Sodium Chloride in control group
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.
Biological: Autologous Umbilical Cord Blood
Autologous Umbilical Cord Blood Mononuclear Cells Therapy in Autism Spectrum Disorder for safety and effect evaluation.
Other Name: Autologous Umbilical Cord Blood Mononuclear Cells Therapy
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04768816
|Contact: Huimei Xiao, MD||+862039151772 ext +firstname.lastname@example.org|
|Contact: Yanqun Chang, PHD||+862039151771 ext +email@example.com|
|Guangdong Women and Children's Hospital and Health Institute||Recruiting|
|Guangzhou, Guangdong, China, 510010|
|Contact: Chang Yanqun, Phd +862039151772 firstname.lastname@example.org|