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NCT Number: NCT07177677

A Study of Mesenchymal Stem Cell in the Treatment of Autism Spectrum Disorder

This clinical trial aims to evaluate the safety and preliminary efficacy of intravenous administration of human bone marrow-derived mesenchymal stem cells (hBMMSCs) in patients with autism spectrum disorder (ASD).

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder characterized primarily by impaired social communication, restricted interests, and repetitive, stereotyped behaviors. Currently, there are no effective therapeutic drugs, and main interventions consist of educational rehabilitation and behavioral management.The purpose of this study is to evaluate the safety and preliminary efficacy of hBMMSC intravenous treatment in patients with ASD. The clinical trial intends to involve 42 participants. The trial is expected to last approximately 2 years.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female ≥6 years old
  • Body weight ≥ 17 kg
  • Meets the diagnostic criteria for Autism Spectrum Disorder (ASD) as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), and confirmed by the Autism Diagnostic Interview-Revised (ADI-R) and the Autism Diagnostic Observation Schedule-2 (ADOS-2)
  • Has either not received any psychotropic medication in the three months prior to enrollment or has been on a stable regimen of psychotropic medication for at least three months
  • The subject and/or their legal guardian(s) agree to participate in the trial and provide signed informed consent.

Exclusion criteria

  • Inability of the subject or their guardian to sufficiently understand instructions in Chinese
  • Active infection (viral, bacterial, fungal, or mycobacterial)
  • A confirmed diagnosis of Rett syndrome, childhood disintegrative disorder, fragile X syndrome, or other genetic/metabolic diseases that may impact cognitive development
  • History of epileptic seizures within 6 months prior to enrollment
  • History of suicide attempts/self-harm, presentation of suicidal ideation, or being judged as the risk of suicidal by the investigator
  • Severe hematologic diseases or active malignancy
  • Severe hepatic or renal disease
  • Participation in a drug clinical trial within 3 months prior to enrollment (unless beyond the protocol-defined wash-out period) or participation in any other stem cell study within the past year
  • A positive skin test result
  • Any other condition which, in the opinion of the investigator, would make the subject unsuitable for participation in this study

Treatment and study plan

hBMMSC

Biological

Group 1: 0.5×10^6 cells/kg (participant's body weight) single dose; Group 2: 1.0×10^6 cells/kg (participant's body weight) single dose; Group 3: 2.0×10^6 cells/kg (participant's body weight) single dose.

Other names: human Bone Marrow Mesenchymal Stem Cell

Primary outcomes

  1. Safety Evaluation of hBMMSC Injection in ASD Patients

    Time frame: 48 weeks

    Adverse events and serious adverse events.

Secondary outcomes

  1. Preliminary Efficacy Evaluation of hBMMSC Injection for Patients with ASD

    Time frame: 48 weeks

    Changes in the scores of the Adaptive Behavior Assessment System (ABAS), Autism Behavior Checklist (ABC), Clinical Global Impression (CGI), Autism Treatment Evaluation Checklist (ATEC), Social Responsiveness Scale(SRS), Repetitive Behavior Scale-Revised (RBS-R), as well as the levels of blood inflammatory factors.

Study contacts

Contact information is provided by the study sponsor or research team.

yuan chen

CONTACT

[email protected]

86-4000918989

Sponsors and collaborators

Lead sponsor

Jiuzhitang Maker (Beijing) Cell Technology Co.,Ltd.

Other

Collaborators

  • Capital Medical University

Registry information

Official study title

Intravenous Injection of Human Bone Marrow Mesenchymal Stem Cell (hBMMSC) in the Treatment of Autism Spectrum Disorder (ASD): An Exploratory Study on the Safety and Preliminary Efficacy

Acronym: ASD

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Sep 17, 2025
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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