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Stem Cell Therapy in Autism Spectrum Disorders

Primary Purpose

Autism Spectrum Disorders

Status
Withdrawn
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
Autologous bone marrow mononuclear cell transplantation
Sponsored by
Neurogen Brain and Spine Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorders focused on measuring autism spectrum disorders, stem cells

Eligibility Criteria

6 Months - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Neurogen brain and spine institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stem cell

Arm Description

autologous bone marrow mononuclear cell transplantation

Outcomes

Primary Outcome Measures

Improvement in the scales for Autism spectrum disorders

Secondary Outcome Measures

Positron Emission Tomography- computed tomography to study change in brain metabolism

Full Information

First Posted
October 28, 2013
Last Updated
October 23, 2018
Sponsor
Neurogen Brain and Spine Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01974973
Brief Title
Stem Cell Therapy in Autism Spectrum Disorders
Official Title
Open Label Study of Autologous Bone Marrow Mononuclear Cells in Autism Spectrum Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Withdrawn
Study Start Date
August 2009 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neurogen Brain and Spine Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorders
Keywords
autism spectrum disorders, stem cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stem cell
Arm Type
Experimental
Arm Description
autologous bone marrow mononuclear cell transplantation
Intervention Type
Procedure
Intervention Name(s)
Autologous bone marrow mononuclear cell transplantation
Intervention Description
Intrathecal autologous bone marrow mononuclear cell transplantation
Primary Outcome Measure Information:
Title
Improvement in the scales for Autism spectrum disorders
Time Frame
Six months
Secondary Outcome Measure Information:
Title
Positron Emission Tomography- computed tomography to study change in brain metabolism
Time Frame
six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Neurogen brain and spine institute
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400071
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19364066
Citation
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. doi: 10.3727/096368908787648074.
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Stem Cell Therapy in Autism Spectrum Disorders

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