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Stem Cell Therapy in Autism Spectrum Disorders

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ClinicalTrials.gov Identifier: NCT01974973
Recruitment Status : Completed
First Posted : November 4, 2013
Last Update Posted : September 26, 2016
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorders Procedure: Autologous bone marrow mononuclear cell transplantation Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label Study of Autologous Bone Marrow Mononuclear Cells in Autism Spectrum Disorders
Study Start Date : August 2009
Actual Primary Completion Date : January 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Stem cell
autologous bone marrow mononuclear cell transplantation
Procedure: Autologous bone marrow mononuclear cell transplantation
Intrathecal autologous bone marrow mononuclear cell transplantation



Primary Outcome Measures :
  1. Improvement in the scales for Autism spectrum disorders [ Time Frame: Six months ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01974973


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

Publications:
Responsible Party: Neurogen Brain and Spine Institute
ClinicalTrials.gov Identifier: NCT01974973     History of Changes
Other Study ID Numbers: NGBSI-02
First Posted: November 4, 2013    Key Record Dates
Last Update Posted: September 26, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders