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Stem Cell Therapy in Autism Spectrum Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01974973
Recruitment Status : Withdrawn
First Posted : November 4, 2013
Last Update Posted : October 25, 2018
Sponsor:
Information provided by (Responsible Party):
Neurogen Brain and Spine Institute

Tracking Information
First Submitted Date  ICMJE October 28, 2013
First Posted Date  ICMJE November 4, 2013
Last Update Posted Date October 25, 2018
Study Start Date  ICMJE August 2009
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2013)
Improvement in the scales for Autism spectrum disorders [ Time Frame: Six months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01974973 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2013)
Positron Emission Tomography- computed tomography to study change in brain metabolism [ Time Frame: six months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stem Cell Therapy in Autism Spectrum Disorders
Official Title  ICMJE Open Label Study of Autologous Bone Marrow Mononuclear Cells in Autism Spectrum Disorders
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Autism Spectrum Disorders
Intervention  ICMJE Procedure: Autologous bone marrow mononuclear cell transplantation
Intrathecal autologous bone marrow mononuclear cell transplantation
Study Arms  ICMJE Experimental: Stem cell
autologous bone marrow mononuclear cell transplantation
Intervention: Procedure: Autologous bone marrow mononuclear cell transplantation
Publications * Geffner LF, Santacruz P, Izurieta M, Flor L, Maldonado B, Auad AH, Montenegro X, Gonzalez R, Silva F. Administration of autologous bone marrow stem cells into spinal cord injury patients via multiple routes is safe and improves their quality of life: comprehensive case studies. Cell Transplant. 2008;17(12):1277-93.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: October 23, 2018)
0
Original Estimated Enrollment  ICMJE
 (submitted: October 28, 2013)
150
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 40 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01974973
Other Study ID Numbers  ICMJE NGBSI-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Neurogen Brain and Spine Institute
Study Sponsor  ICMJE Neurogen Brain and Spine Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Neurogen Brain and Spine Institute
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP