Stem Cell Therapy in Spinal Cord Injury

Phase 2WithdrawnNCT02009124

Neurogen Brain and Spine Institute

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Spinal Cord Injury

Interventions

Autologous bone marrow mononuclear cell transplantationBIOLOGICAL

Bone marrow is aspirated by a standard procedure. Mononuclear cells are separated by density gradient method and then injected intrathecally by a standard lumbar puncture procedure

Eligibility

Sex: ALLMin age: 12 MonthsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Neurogen brain and spine institute

Mumbai, Maharashtra, India

Outcomes

Primary Outcomes

Change in clinical symptoms of spinal cord injury after 6 months

Time frame: 6 months

Secondary Outcomes

Functional independence measure (FIM)

It is a standard objective scale used for functional evaluation of the spinal cord injury patients. Its reliability and validity has been well established. It will be marked by a certified occupational therapy expert before the intervention and 6 months after the intervention.

Time frame: 6 months

Data from ClinicalTrials.gov

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