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

Primary Purpose

Safety Issues;Effect of Drugs

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
0.9% Sodium Chloride
Autologous Umbilical Cord Blood
Sponsored by
Guangdong Women and Children Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Safety Issues;Effect of Drugs focused on measuring Autism Spectrum Disorder;Autologous Umbilical Cord Blood;safety;effect

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Guangdong Women and Children's Hospital and Health InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo Comparator

Experimental

Arm Description

Placebo 0.9% sodium chloride infusion any time after entering the Placebo Group, doses is 20-30ml. The infusion speed is 1ml/min.

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.

Outcomes

Primary Outcome Measures

ABC
The Change of ABC score is used to assess the social and behavior function of the children who were diagnosised as ASD.
CARS
The Change of CARS score is used to assess the social and behavior function of the children who were diagnosised as ASD.

Secondary Outcome Measures

Full Information

First Posted
February 21, 2021
Last Updated
February 21, 2021
Sponsor
Guangdong Women and Children Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04768816
Brief Title
Clinical Effect and Safety of Autologous Umbilical Cord Blood Transfusion in the Treatment of Autism Spectrum Disorder
Official Title
Clinical Effect and Safety of Autologous Umbilical Cord Blood Transfusion in the Treatment of Autism Spectrum Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangdong Women and Children Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Safety Issues;Effect of Drugs
Keywords
Autism Spectrum Disorder;Autologous Umbilical Cord Blood;safety;effect

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo Comparator
Arm Type
Placebo Comparator
Arm Description
Placebo 0.9% sodium chloride infusion any time after entering the Placebo Group, doses is 20-30ml. The infusion speed is 1ml/min.
Arm Title
Experimental
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
0.9% Sodium Chloride
Intervention Description
0.9% Sodium Chloride in control group
Intervention Type
Biological
Intervention Name(s)
Autologous Umbilical Cord Blood
Other Intervention Name(s)
Autologous Umbilical Cord Blood Mononuclear Cells Therapy
Intervention Description
Autologous Umbilical Cord Blood Mononuclear Cells Therapy in Autism Spectrum Disorder for safety and effect evaluation.
Primary Outcome Measure Information:
Title
ABC
Description
The Change of ABC score is used to assess the social and behavior function of the children who were diagnosised as ASD.
Time Frame
up to 24 months after therapy at a 3-month interval
Title
CARS
Description
The Change of CARS score is used to assess the social and behavior function of the children who were diagnosised as ASD.
Time Frame
up to 24 months after therapy at a 3-month interval

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huimei Xiao, MD
Phone
+862039151772
Ext
+86
Email
xiaowu2010727@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yanqun Chang, PHD
Phone
+862039151771
Ext
+86
Email
sfycyq@sina.com
Facility Information:
Facility Name
Guangdong Women and Children's Hospital and Health Institute
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510010
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chang Yanqun, Phd
Phone
+862039151772
Email
sfycyq@sina.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28378499
Citation
Dawson G, Sun JM, Davlantis KS, Murias M, Franz L, Troy J, Simmons R, Sabatos-DeVito M, Durham R, Kurtzberg J. Autologous Cord Blood Infusions Are Safe and Feasible in Young Children with Autism Spectrum Disorder: Results of a Single-Center Phase I Open-Label Trial. Stem Cells Transl Med. 2017 May;6(5):1332-1339. doi: 10.1002/sctm.16-0474. Epub 2017 Apr 5.
Results Reference
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PubMed Identifier
32444220
Citation
Dawson G, Sun JM, Baker J, Carpenter K, Compton S, Deaver M, Franz L, Heilbron N, Herold B, Horrigan J, Howard J, Kosinski A, Major S, Murias M, Page K, Prasad VK, Sabatos-DeVito M, Sanfilippo F, Sikich L, Simmons R, Song A, Vermeer S, Waters-Pick B, Troy J, Kurtzberg J. A Phase II Randomized Clinical Trial of the Safety and Efficacy of Intravenous Umbilical Cord Blood Infusion for Treatment of Children with Autism Spectrum Disorder. J Pediatr. 2020 Jul;222:164-173.e5. doi: 10.1016/j.jpeds.2020.03.011. Epub 2020 May 19.
Results Reference
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Clinical Effect and Safety of Autologous Umbilical Cord Blood Transfusion in the Treatment of Autism Spectrum Disorder

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