Stem Cell Therapy in Spinal Cord Injury

Neurogen Brain and Spine Institute

Status and phase: Withdrawn; Phase 2

Conditions: Spinal Cord Injury

Treatments: Biological: Autologous bone marrow mononuclear cell transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT02009124

NGBSI-03

Details and patient eligibility

About

The purpose of this study is to study the effect of stem cell therapy on common symptoms in patients with spinal cord injury.

Full description

Autologous bone marrow mononuclear cells are administered intrathecally by a standard procedure followed by vigorous rehabilitation therapy.

Sex: All

Ages: 12 months to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed cases of any type of spinal cord injury
• age above 12 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Stem cell

Experimental group

Description:

autologous bone marrow mononuclear cell transplantation

Treatment:

Biological: Autologous bone marrow mononuclear cell transplantation

Control

No Intervention group

Description:

Stem cell therapy is not done for this group of spinal cord injury patients