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

February 21, 2021 updated by: Xiao Huimei, Guangdong Women and Children Hospital
To study the clinical efficacy and safety of autologous umbilical cord blood transfusion in the treatment of autism spectrum disorder.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Yanqun Chang, PHD
  • Phone Number: +86 +862039151771
  • Email: sfycyq@sina.com

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510010
        • Recruiting
        • Guangdong women and children's hospital and health institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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 Names:
  • Autologous Umbilical Cord Blood Mononuclear Cells Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
up to 24 months after therapy at a 3-month interval
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.
up to 24 months after therapy at a 3-month interval

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Women and Children Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2019

Primary Completion (ANTICIPATED)

December 31, 2022

Study Completion (ANTICIPATED)

December 31, 2024

Study Registration Dates

First Submitted

February 21, 2021

First Submitted That Met QC Criteria

February 21, 2021

First Posted (ACTUAL)

February 24, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 24, 2021

Last Update Submitted That Met QC Criteria

February 21, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GuangdongWCHASD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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