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

Safety Issues;Effect of Drugs Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04768816
• Other study ID #: GuangdongWCHASD
• Status: Recruiting
• Phase: Phase 1
• Start date: July 1, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2021
• Source: Guangdong Women and Children Hospital
• Contact: Huimei Xiao, MD
• Phone: +862039151772
• Email: xiaowu2010727[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Safety Issues;Effect of Drugs

Intervention

Drug:
• 0.9% Sodium Chloride
0.9% Sodium Chloride in control group

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

Locations

Country	Name	City	State
China	Guangdong Women and Children's Hospital and Health Institute	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Women and Children Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ABC	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
Primary	CARS	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