Safety and Efficacy of Stem Cell Therapy in Spinal Cord Injury

Phase 1WithdrawnNCT02027246

Neurogen Brain and Spine Institute

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

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: 8 MonthsMax age: 63 Years

Medical Language ↔ Plain English

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

Locations (1)

Neurogen brain and spine institute

Mumbai, Maharashtra, India

Outcomes

Primary Outcomes

Change in clinical symptoms

clinical symptoms were assessed based on the observation of the experts

Time frame: 6 months

Secondary Outcomes

Functional Independence Measure (FIM)

Functional Independence Measure (FIM) is a standard scale performed before and 6 months after the intervention to measure the functional ability of the patients.

Time frame: 6 months

Data from ClinicalTrials.gov

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