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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2024-12-31

Brief Summary

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To study the clinical efficacy and safety of autologous umbilical cord blood transfusion in the treatment of autism spectrum disorder.

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Detailed Description

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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

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Safety Issues;Effect of Drugs

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

0.9% Sodium Chloride

Intervention Type DRUG

0.9% Sodium Chloride in control group

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.

Group Type EXPERIMENTAL

Autologous Umbilical Cord Blood

Intervention Type BIOLOGICAL

Autologous Umbilical Cord Blood Mononuclear Cells Therapy in Autism Spectrum Disorder for safety and effect evaluation.

Interventions

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0.9% Sodium Chloride

0.9% Sodium Chloride in control group

Intervention Type DRUG

Autologous Umbilical Cord Blood

Autologous Umbilical Cord Blood Mononuclear Cells Therapy in Autism Spectrum Disorder for safety and effect evaluation.

Intervention Type BIOLOGICAL

Other Intervention Names

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Autologous Umbilical Cord Blood Mononuclear Cells Therapy

Eligibility Criteria

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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.

Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No