- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01974973
Stem Cell Therapy in Autism Spectrum Disorders
October 23, 2018 updated by: Neurogen Brain and Spine Institute
Open Label Study of Autologous Bone Marrow Mononuclear Cells in Autism Spectrum Disorders
The purpose of this study was to study the effect of stem cell therapy on common symptoms in patients with autism spectrum disorders
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maharashtra
-
Mumbai, Maharashtra, India, 400071
- Neurogen brain and spine institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 40 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Stem cell
autologous bone marrow mononuclear cell transplantation
|
Intrathecal autologous bone marrow mononuclear cell transplantation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Improvement in the scales for Autism spectrum disorders
Time Frame: Six months
|
Six months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Positron Emission Tomography- computed tomography to study change in brain metabolism
Time Frame: six months
|
six months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2009
Primary Completion (Actual)
January 1, 2016
Study Completion (Actual)
May 1, 2016
Study Registration Dates
First Submitted
October 28, 2013
First Submitted That Met QC Criteria
October 28, 2013
First Posted (Estimate)
November 3, 2013
Study Record Updates
Last Update Posted (Actual)
October 25, 2018
Last Update Submitted That Met QC Criteria
October 23, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NGBSI-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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