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Stem Cell Therapy in Autism Spectrum Disorders

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Neurogen Brain and Spine Institute
Sponsor:
Information provided by (Responsible Party):
Neurogen Brain and Spine Institute
ClinicalTrials.gov Identifier:
NCT01974973
First received: October 28, 2013
Last updated: September 13, 2014
Last verified: September 2014
  Purpose

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


Condition Intervention Phase
Autism Spectrum Disorders
Procedure: Autologous bone marrow mononuclear cell transplantation
Procedure: Autologous bone marrow mononuclear cell transplantation in patients with autism
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Label Study of Autologous Bone Marrow Mononuclear Cells in Autism Spectrum Disorders

Resource links provided by NLM:


Further study details as provided by Neurogen Brain and Spine Institute:

Primary Outcome Measures:
  • Improvement in the scales for Autism spectrum disorders [ Time Frame: Six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Positron Emission Tomography- computed tomography to study change in brain metabolism [ Time Frame: six months ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: August 2009
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stem cell
autologous bone marrow mononuclear cell transplantation
Procedure: Autologous bone marrow mononuclear cell transplantation Procedure: Autologous bone marrow mononuclear cell transplantation in patients with autism

  Eligibility

Ages Eligible for Study:   6 Months to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01974973

Contacts
Contact: Alok K Sharma, M.S, M.Ch 91-22-25281610 alok276@gmail.com

Locations
India
Neurogen brain and spine institute Recruiting
Mumbai, Maharashtra, India, 400071
Contact: Alok K Sharma, M.S, M.Ch.    91-22-25281610    alok276@gmail.com   
Sponsors and Collaborators
Neurogen Brain and Spine Institute
  More Information

Publications:
Responsible Party: Neurogen Brain and Spine Institute
ClinicalTrials.gov Identifier: NCT01974973     History of Changes
Other Study ID Numbers: NGBSI-02
Study First Received: October 28, 2013
Last Updated: September 13, 2014
Health Authority: India: Indian Council of Medical Research

Keywords provided by Neurogen Brain and Spine Institute:
autism spectrum disorders
stem cells

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Disease
Mental Disorders
Mental Disorders Diagnosed in Childhood
Pathologic Processes

ClinicalTrials.gov processed this record on November 27, 2014