Stem Cell Therapy in Mental Retardation

October 23, 2018 updated by: Neurogen Brain and Spine Institute
The purpose of this study was to analyze the benefit of autologous mononuclear cell therapy in mental retardation.

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Withdrawn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

  • India
    • Maharashtra
      • Navi Mumbai, Maharashtra, India
        • 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

10 months to 38 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diagnosed cases of mental retardation
  • 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
Bone marrow mononuclear cell transplantation
Biological: Stem Cell
Autologous bone marrow mononuclear cell transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in common clinical symptoms of mental retardation
Time Frame: 1 year
Change in symptoms such as cognition, remote memory, problem solving,understanding of relationships,social interaction,communication,self care, activities of daily living will be recorded at 1 year follow up.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neurogen Brain and Spine Institute

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.

General Publications

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

September 1, 2011

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

September 12, 2014

First Submitted That Met QC Criteria

September 17, 2014

First Posted (Estimate)

September 22, 2014

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-15

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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