Status:
NOT_YET_RECRUITING
A Study of Mesenchymal Stem Cell in the Treatment of Autism Spectrum Disorder
Lead Sponsor:
Jiuzhitang Maker (Beijing) Cell Technology Co.,Ltd.
Collaborating Sponsors:
Capital Medical University
Conditions:
Autism Spectrum Disorder
Eligibility:
All Genders
6+ years
Phase:
PHASE1
Brief Summary
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 di...
Detailed Description
Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder characterized primarily by impaired social communication, restricted interests, and repetitive, stereotyped behaviors. Currently, there ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2028
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT07177677
Start Date
September 30 2025
End Date
August 30 2028
Last Update
September 17 2025
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