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Safety and Efficacy of Stem Cell Therapy in Patients With Autism

NCT01343511 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2011-10-14

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Shandong Jiaotong Hospital

    collaborator UNKNOWN

  • Association for the Handicapped Of Jinan

    collaborator UNKNOWN

  • Shenzhen Beike Bio-Technology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yongtao Lv · Shandong Jiaotong Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2010-06-30
Completion
2011-05-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01343511 on ClinicalTrials.gov