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

NCT07177677 | Not Yet Recruiting Phase 1

• 1 other identifier: MKMSC-CT-003-1
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

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 disorder (ASD).

Conditions

Autism Spectrum Disorder

Keywords

human Bone Marrow Mesenchymal Stem Cell (hBMMSC); Autism Spectrum Disorder (ASD)

Outcome Measures

Primary Outcomes (1)

• Safety Evaluation of hBMMSC Injection in ASD Patients

  Adverse events and serious adverse events.

  48 weeks

Secondary Outcomes (1)

• Preliminary Efficacy Evaluation of hBMMSC Injection for Patients with ASD

  48 weeks

Study Arms (1)

hBMMSC 0.5×10^6 cells/kg

EXPERIMENTAL

human Bone Marrow Mesenchymal Stem Cell (hBMMSC) 0.5×10\^6 cells/kg、 1.0×10\^6 cells/kg、 2.0×10\^6 cells/kg

Biological: hBMMSC

Interventions

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.

Also known as: human Bone Marrow Mesenchymal Stem Cell

hBMMSC 0.5×10^6 cells/kg

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiuzhitang Maker (Beijing) Cell Technology Co.,Ltd.: lead
• Capital Medical University: collaborator

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

yuan chen

CONTACT

86-4000918989; ychen@jztmaker.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 17, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): August 30, 2028
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share