Stem Cell Therapy in Autism Spectrum Disorders

Phase 1

Withdrawn

• Conditions: Autism Spectrum Disorders
• Interventions: Procedure: Autologous bone marrow mononuclear cell transplantation

• Registration Number: NCT01974973
• Lead Sponsor: Neurogen Brain and Spine Institute

Brief Summary

The purpose of this study was to study the effect of stem cell therapy on common symptoms in patients with autism spectrum disorders

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2013-10-28
• Study First Submitted QC: 2013-10-28
• Study First Posted: 2013-11-03
• Primary Completion: 2016-01
• Study Completion: 2016-05
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-23
• Last Update Posted: 2018-10-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Diagnosed cases of any type of autism spectrum disorders
• age above 6 months

Exclusion Criteria

• presence of acute infections such as Human immunodeficiency virus/Hepatitis B Virus/Hepatitis C Virus
• malignancies
• bleeding tendencies
• pneumonia
• renal failure
• severe liver dysfunction
• severe anemia [Hemoglobin < 8]
• any bone marrow disorder
• space occupying lesion in brain
• other acute medical conditions such as respiratory infection and pyrexia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stem cell	Autologous bone marrow mononuclear cell transplantation	autologous bone marrow mononuclear cell transplantation

Primary Outcome Measures

Name	Time	Method
Improvement in the scales for Autism spectrum disorders	Six months

Secondary Outcome Measures

Name	Time	Method
Positron Emission Tomography- computed tomography to study change in brain metabolism	six months

Trial Locations

Locations (1)

Neurogen brain and spine institute; 🇮🇳 Mumbai, Maharashtra, India