Cell Transplant in Spinal Cord Injury Patients

January 2, 2009 updated by: Cairo University

Autologous Bone Marrow Derived Cell Transplant in Spinal Cord Injury Patients

This study is designed to assess the safety of autologous bone marrow derived cell transplant in chronic spinal cord injury patients. The hypothesis is that the availability of bone marrow derived mesenchymal stem cells at the sites of injury promote neuronal regeneration.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 2
  • 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

  • Egypt
      • Cairo, Egypt
        • Cairo University School of Medicine

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

10 years to 36 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Traumatic spinal cord injury
  • No concomitant systemic disease
  • No progress on physiotherapy for at least 6 months
  • Duration of injury from 10 months to 3 years

Exclusion Criteria:

  • Non-traumatic spinal cord injury whether transverse myelitis or demyelination
  • Concomitant systemic disease
  • Progress can be observed on physiotherapy
  • Acute injury or duration of injury less than 10 months

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
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: BM transplant with physiotherapy
Autologous BM transplant
Procedure: Physical therapy
Procedure: Autologous bone marrow transplant
ACTIVE_COMPARATOR: Physiotherapy only
conventional physical therapy for chronic spinal cord injury.
Procedure: Physical therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety of autologous BM transplant measured by absence of neuronal changes, infections or increased intracranial tension, and monitoring for any abnormal growth or tumor formation by MRI.
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy of BM cell transplant in improving neurological functions in patients with chronic SCI. Improvement in motor, sensory and sphincteric functions, and quality of life using ASIA scores and MRI.
Time Frame: 18 months
18 months

Collaborators and Investigators

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

Sponsor

Cairo University

Collaborators

Alexandria University
Al-Azhar University
Medical Military Academy, Egypt

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

May 1, 2005

Primary Completion (ACTUAL)

December 1, 2008

Study Completion (ACTUAL)

December 1, 2008

Study Registration Dates

First Submitted

December 31, 2008

First Submitted That Met QC Criteria

January 2, 2009

First Posted (ESTIMATE)

January 5, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

January 5, 2009

Last Update Submitted That Met QC Criteria

January 2, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EGY-SCI-1

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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