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NCT02245724 Clinical Trial

Stem Cell Therapy in Mental Retardation

Mental Retardation Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02245724
Other study ID # NGBSI-15
Secondary ID
Status Withdrawn
Phase Phase 1
First received
Last updated
Start date September 2011
Est. completion date September 2016

Study information
Verified date October 2018
Source Neurogen Brain and Spine Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study was to analyze the benefit of autologous mononuclear cell therapy in mental retardation.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date September 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender All
Age group 6 Months to 40 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Biological:
• Stem Cell
Autologous bone marrow mononuclear cell transplantation

Locations
Country Name City State
India Neurogen brain and spine institute Navi Mumbai Maharashtra

Sponsors (1)
Lead Sponsor Collaborator
Neurogen Brain and Spine Institute

Country where clinical trial is conducted

India, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in common clinical symptoms of mental retardation 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
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