NCT01343511

Safety and Efficacy of Stem Cell Therapy in Patients With Autism

Phase Ι/Π Study of Stem Cell Therapy in Patients With Autism

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Shenzhen Beike Bio-Technology Co., Ltd. · Industry
• Sex: All
• Age: 3 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

Autism is one of those disorders in Autism spectrum disorders (ASD), which characterized by social interaction abnormalities, impaired verbal and non-verbal communication, and repetitive, obsessive behavior, while the therapeutic effect of current treatments remains limited progress .Neural hypoperfusion and immune deregulation are the two key pathologies associated with Autism. Human umbilical cord mesenchymal stem cells (hUC-MSCs) and human cord blood mononuclear cells (hCB-MNCs) have been shown to have the ability to modulate the immune response and enhance angiogenesis, suggesting the novel and promising therapeutic strategy. In this study, the safety and efficacy of hUC-MSCs and hCB-MNCs transplantation will be evaluated in patients with Autism.

Detailed description

To investigate the safety and efficacy of human cord blood mononuclear cells and human umbilical cord mesenchymal stem cells transplantation in patients of Autism.

Conditions

• Autism

Interventions

Type	Name	Description
BIOLOGICAL	human cord blood mononuclear cells	Participants will be given rehabilitation therapy plus hCB-MNCs transplantation.
BIOLOGICAL	human cord blood mononuclear cells and human umbilical cord mesenchymal stem cells	Participants will be given rehabilitation therapy plus and hCB-MNCs and hUC-MSCs transplantation.

Timeline

• Start date: 2009-03-01
• Primary completion: 2010-06-01
• Completion: 2011-05-01
• First posted: 2011-04-28
• Last updated: 2011-10-14

Locations

1 site across 1 country: China