Safety and Efficacy of Stem Cell Therapy in Spinal Cord Injury

October 23, 2018 updated by: Neurogen Brain and Spine Institute

Autologous Bone Marrow Mononuclear Cell Therapy for Spinal Cord Injury

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Maharashtra
      • Mumbai, Maharashtra, India, 400071
        • Neurogen brain and spine institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 months to 63 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Stem cell
Autologous bone marrow mononuclear cell transplantation
Biological: Autologous bone marrow mononuclear cell transplantation
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in clinical symptoms
Time Frame: 6 months
clinical symptoms were assessed based on the observation of the experts
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neurogen Brain and Spine Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (ACTUAL)

August 1, 2012

Study Completion (ACTUAL)

February 1, 2013

Study Registration Dates

First Submitted

December 18, 2013

First Submitted That Met QC Criteria

January 2, 2014

First Posted (ESTIMATE)

January 6, 2014

Study Record Updates

Last Update Posted (ACTUAL)

October 25, 2018

Last Update Submitted That Met QC Criteria

October 23, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NGBSI-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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