Clinical Effect and Safety of Autologous Umbilical Cord Blood Transfusion in the Treatment of Autism Spectrum Disorder
1 other identifier
interventional
25
1 country
1
Brief Summary
To study the clinical efficacy and safety of autologous umbilical cord blood transfusion in the treatment of autism spectrum disorder.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jul 2019
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2019
CompletedFirst Submitted
Initial submission to the registry
February 21, 2021
CompletedFirst Posted
Study publicly available on registry
February 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedFebruary 24, 2021
February 1, 2021
3.5 years
February 21, 2021
February 21, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Study Arms (2)
Placebo Comparator
PLACEBO COMPARATORPlacebo 0.9% sodium chloride infusion any time after entering the Placebo Group, doses is 20-30ml. The infusion speed is 1ml/min.
Experimental
EXPERIMENTALAutologous 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.
Interventions
Autologous Umbilical Cord Blood Mononuclear Cells Therapy in Autism Spectrum Disorder for safety and effect evaluation.
Eligibility Criteria
You may qualify if:
- A patient who was diagnosed with ASD.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Guangdong Women and Children's Hospital and Health Institute
Guangzhou, Guangdong, 510010, China
Related Publications (2)
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.
PMID: 28378499BACKGROUNDDawson 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.
PMID: 32444220BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
February 21, 2021
First Posted
February 24, 2021
Study Start
July 1, 2019
Primary Completion
December 31, 2022
Study Completion
December 31, 2024
Last Updated
February 24, 2021
Record last verified: 2021-02