Safety and Efficacy of Stem Cell Therapy in Spinal Cord Injury

Neurogen Brain and Spine Institute

Status and phase: Withdrawn; Phase 1

Conditions: Spinal Cord Injury

Treatments: Biological: Autologous bone marrow mononuclear cell transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT02027246

NGBSI-05

Details and patient eligibility

About

The aim of this study was to study the effect of stem cell therapy on common symptoms of spinal cord injury patients.

Full description

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

Sex: All

Ages: 8 months to 63 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed cases of any type of chronic Spinal cord 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
• other acute medical conditions such as respiratory infection
• pregnancy and lactation

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 cell

Experimental group

Description:

Autologous bone marrow mononuclear cell transplantation

Treatment:

Biological: Autologous bone marrow mononuclear cell transplantation