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Cell Transplant in Spinal Cord Injury Patients

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ClinicalTrials.gov Identifier: NCT00816803
Recruitment Status : Completed
First Posted : January 5, 2009
Last Update Posted : January 5, 2009
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Spinal Cord Injury Procedure: Autologous bone marrow transplant Procedure: Physical therapy Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Autologous Bone Marrow Derived Cell Transplant in Spinal Cord Injury Patients
Study Start Date : May 2005
Primary Completion Date : December 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. 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 ]

Eligibility Criteria

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

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

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 Posted: January 5, 2009    Key Record Dates
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