NCT07177677Not yet recruitingPhase 1
A Study of Mesenchymal Stem Cell in the Treatment of Autism Spectrum Disorder
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
Source: ClinicalTrials.gov · Last updated 17 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- First submitted
- 2 Sept 2025
- Start date
- 30 Sept 2025
- Primary completion date
- 30 Dec 2026
- Lead sponsor
- Jiuzhitang Maker (Beijing) Cell Technology Co.,Ltd.
- Diseases
- Autism
- NCT number
- NCT07177677
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 42
- From 30 Sept 2025 to the primary completion date, 30 Dec 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of epileptic seizures within 6 months prior to enrollment
- 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
Other illness
- 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 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
- Any other condition which, in the opinion of the investigator, would make the subject unsuitable for participation in this study
Other
- Inability of the subject or their guardian to sufficiently understand instructions in Chinese
- A positive skin test result
Who the study is looking for
- 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.
Age in the registry: 6 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.