Autologous Stem Cell Therapy in Stroke

Phase 1

Withdrawn

• Conditions: Stroke
• Interventions: Biological: Stem cell

• Registration Number: NCT02245698
• Lead Sponsor: Neurogen Brain and Spine Institute

Brief Summary

The purpose of this study was to study the safety and effect of stem cell therapy on the functional recovery in patients with sub acute/chronic stroke.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2014-09-12
• Study First Submitted QC: 2014-09-17
• Study First Posted: 2014-09-19
• Primary Completion: 2018-06
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-23
• Last Update Posted: 2018-10-25
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: WITHDRAWN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

Inclusion Criteria

• Age18 years-80 years
• diagnosed as stroke by clinical and MRI findings

Exclusion Criteria

• presence of respiratory distress
• presence of acute infections such as Human Immunodeficient Virus/Hepatitis B Virus/ Hepatitis C Virus
• malignancies
• acute medical conditions such as respiratory infection, fever
• hemoglobin less than 8
• bleeding tendency
• bone marrow disorder
• left ventricular ejection fraction < 30%
• pregnancy or breastfeeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stem Cell	Stem cell	Bone marrow mononuclear cells

Primary Outcome Measures

Name	Time	Method
Functional Independence Measure	1 year	Functional Independence Measure scale assesses the patients ability to carry out activities of daily living. At the follow up of 1 year, every patient in this study will be reevaluated on this scale.

Trial Locations

Locations (1)

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