Safety and Efficacy of Autologous Stem Cell Therapy in Chronic Stroke

Neurogen Brain and Spine Institute

Status and phase: Withdrawn; Phase 1

Conditions: Cerebrovascular Accident

Treatments: Biological: Autologous bone marrow mononuclear cell transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT02065778

NGBSI-08

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• males and females
• above 18 years of age
• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Stem Cells

Experimental group

Description:

autologous bone marrow mononuclear cell transplantation

Treatment:

Biological: Autologous bone marrow mononuclear cell transplantation