NCT07177677

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Jiuzhitang Maker (Beijing) Cell Technology Co.,Ltd. · Academic / Other
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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.

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
BIOLOGICAL	hBMMSC	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.

Timeline

• Start date: 2025-09-30
• Primary completion: 2026-12-30
• Completion: 2028-08-30
• First posted: 2025-09-17
• Last updated: 2025-09-17