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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

December 31, 2008
January 2, 2009
May 2005
December 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00816803 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Cell Transplant in Spinal Cord Injury Patients
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.

Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Chronic Spinal Cord Injury
  • Procedure: Autologous bone marrow transplant
  • Procedure: Physical therapy
  • Experimental: BM transplant with physiotherapy
    Autologous BM transplant
    Interventions:
    • Procedure: Autologous bone marrow transplant
    • Procedure: Physical therapy
  • Active Comparator: Physiotherapy only
    conventional physical therapy for chronic spinal cord injury.
    Intervention: Procedure: Physical therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
10 Years to 36 Years
No
Contact information is only displayed when the study is recruiting subjects
Egypt
 
NCT00816803
EGY-SCI-1
Yes
Hatem E. Sabaawy, M, PhD, Assistant Professor of Medicine, Cairo University, and the Cancer Institute of New Jersey, UMDNJ/RWJMS
Cairo University
  • Al-Azhar University
  • Medical Military Academy, Egypt
  • Alexandria University
Not Provided
Cairo University
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP