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Trial record 7 of 587 for:    Autism Spectrum Disorder

Stem Cell Therapy in Autism Spectrum Disorders

This study has been completed.
Information provided by (Responsible Party):
Neurogen Brain and Spine Institute Identifier:
First received: October 28, 2013
Last updated: September 23, 2016
Last verified: September 2016
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
Phase 1

Study Type: Interventional
Study Design: 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 ]

Secondary Outcome Measures:
  • Positron Emission Tomography- computed tomography to study change in brain metabolism [ Time Frame: six months ]

Enrollment: 162
Study Start Date: August 2009
Study Completion Date: May 2016
Primary Completion Date: January 2016 (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
Intrathecal autologous bone marrow mononuclear cell transplantation


Ages Eligible for Study:   6 Months to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01974973

Neurogen brain and spine institute
Mumbai, Maharashtra, India, 400071
Sponsors and Collaborators
Neurogen Brain and Spine Institute
  More Information

Responsible Party: Neurogen Brain and Spine Institute Identifier: NCT01974973     History of Changes
Other Study ID Numbers: NGBSI-02
Study First Received: October 28, 2013
Last Updated: September 23, 2016
Individual Participant Data  
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders processed this record on May 22, 2017