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Cell Transplant in Spinal Cord Injury Patients

This study has been completed.
Sponsor:
Collaborators:
Al-Azhar University
Medical Military Academy, Egypt
Alexandria University
Information provided by:
Cairo University
ClinicalTrials.gov Identifier:
NCT00816803
First received: December 31, 2008
Last updated: January 2, 2009
Last verified: January 2009
History of Changes
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Autologous Bone Marrow Derived Cell Transplant in Spinal Cord Injury Patients

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   10 Years to 36 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 31, 2008
Last Updated: January 2, 2009
Health Authority: Egypt: Ministry of Health and Population

Keywords provided by Cairo University:
Spinal cord injury

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

ClinicalTrials.gov processed this record on May 19, 2013