Stem Cell Therapy in Traumatic Brain Injury

Phase 1

Withdrawn

• Conditions: Traumatic Brain Injury
• Interventions: Biological: Autologous bone marrow mononuclear cell transplantation

• Registration Number: NCT02028104
• Lead Sponsor: Neurogen Brain and Spine Institute

Brief Summary

The purpose of this study was to study the effect of stem cell therapy on common symptoms in patients with Traumatic Brain Injury

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2014-01-03
• Study First Submitted QC: 2014-01-03
• Study First Posted: 2014-01-06
• Primary Completion: 2016-04
• 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• Status: WITHDRAWN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 chronic traumatic brain injury
• 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
• pregnancy
• lactation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
stem cells	Autologous bone marrow mononuclear cell transplantation	autologous bone marrow mononuclear cell transplantation

Primary Outcome Measures

Name	Time	Method
Change in clinical symptoms of traumatic brain injury	6 months

Secondary Outcome Measures

Name	Time	Method
Disability Rating scale	6 months

Trial Locations

Locations (1)

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