Stem Cell Therapy in Mental Retardation

Phase 1

Withdrawn

• Conditions: Mental Retardation
• Interventions: Biological: Stem Cell

• Registration Number: NCT02245724
• Lead Sponsor: Neurogen Brain and Spine Institute

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2014-09-12
• Study First Submitted QC: 2014-09-17
• Study First Posted: 2014-09-22
• Primary Completion: 2016-03
• Study Completion: 2016-09
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-23
• Last Update Posted: 2018-10-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stem Cell	Stem Cell	Bone marrow mononuclear cell transplantation

Primary Outcome Measures

Name	Time	Method
Change in common clinical symptoms of mental retardation	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.

Trial Locations

Locations (1)

Neurogen brain and spine institute; 🇮🇳 Navi Mumbai, Maharashtra, India