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Cell Transplant in Spinal Cord Injury Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00816803
First Posted: January 5, 2009
Last Update Posted: January 5, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Al-Azhar University
Medical Military Academy, Egypt
Alexandria University
Information provided by:
Cairo University
  Purpose
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.

Condition Intervention Phase
Chronic Spinal Cord Injury Procedure: Autologous bone marrow transplant Procedure: Physical therapy Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Autologous Bone Marrow Derived Cell Transplant in Spinal Cord Injury Patients

Resource links provided by NLM:


Further study details as provided by Cairo University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 80
Study Start Date: May 2005
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BM transplant with physiotherapy
Autologous BM transplant
Procedure: Autologous bone marrow transplant Procedure: Physical therapy
Active Comparator: Physiotherapy only
conventional physical therapy for chronic spinal cord injury.
Procedure: Physical therapy

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 36 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00816803


Locations
Egypt
Cairo University School of Medicine
Cairo, Egypt
Sponsors and Collaborators
Cairo University
Al-Azhar University
Medical Military Academy, Egypt
Alexandria University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hatem E. Sabaawy, M, PhD, Assistant Professor of Medicine, Cairo University, and the Cancer Institute of New Jersey, UMDNJ/RWJMS
ClinicalTrials.gov Identifier: NCT00816803     History of Changes
Other Study ID Numbers: EGY-SCI-1
First Submitted: December 31, 2008
First Posted: January 5, 2009
Last Update Posted: January 5, 2009
Last Verified: January 2009

Keywords provided by Cairo University:
Spinal cord injury

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System