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Clinical Effect and Safety of Autologous Umbilical Cord Blood Transfusion in the Treatment of Autism Spectrum Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04768816
Recruitment Status : Recruiting
First Posted : February 24, 2021
Last Update Posted : February 24, 2021
Sponsor:
Information provided by (Responsible Party):
Xiao Huimei, 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.

Condition or disease Intervention/treatment Phase
Safety Issues;Effect of Drugs Drug: 0.9% Sodium Chloride Biological: Autologous Umbilical Cord Blood Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

Experimental: 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.
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




Primary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Huimei Xiao, MD +862039151772 ext +86 xiaowu2010727@163.com
Contact: Yanqun Chang, PHD +862039151771 ext +86 sfycyq@sina.com

Locations
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China, Guangdong
Guangdong Women and Children's Hospital and Health Institute Recruiting
Guangzhou, Guangdong, China, 510010
Contact: Chang Yanqun, Phd    +862039151772    sfycyq@sina.com   
Sponsors and Collaborators
Guangdong Women and Children Hospital
Publications:
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Responsible Party: Xiao Huimei, Dr, Guangdong Women and Children Hospital
ClinicalTrials.gov Identifier: NCT04768816    
Other Study ID Numbers: GuangdongWCHASD
First Posted: February 24, 2021    Key Record Dates
Last Update Posted: February 24, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiao Huimei, Guangdong Women and Children Hospital:
Autism Spectrum Disorder;Autologous Umbilical Cord Blood;safety;effect
Additional relevant MeSH terms:
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Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders