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Trial record 23 of 28 for:    stem cell Spinal Cord Injury AND marrow

Cell Transplant in Spinal Cord Injury Patients

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.
ClinicalTrials.gov Identifier: NCT00816803
Recruitment Status : Completed
First Posted : January 5, 2009
Last Update Posted : January 5, 2009
Sponsor:
Collaborators:
Al-Azhar University
Medical Military Academy, Egypt
Alexandria University
Information provided by:
Cairo University

Tracking Information
First Submitted Date  ICMJE December 31, 2008
First Posted Date  ICMJE January 5, 2009
Last Update Posted Date January 5, 2009
Study Start Date  ICMJE May 2005
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 2, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 2, 2009)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cell Transplant in Spinal Cord Injury Patients
Official Title  ICMJE Autologous Bone Marrow Derived Cell Transplant in Spinal Cord Injury Patients
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Spinal Cord Injury
Intervention  ICMJE
  • Procedure: Autologous bone marrow transplant
  • Procedure: Physical therapy
Study Arms  ICMJE
  • 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
Publications * El-Kheir WA, Gabr H, Awad MR, Ghannam O, Barakat Y, Farghali HA, El Maadawi ZM, Ewes I, Sabaawy HE. Autologous bone marrow-derived cell therapy combined with physical therapy induces functional improvement in chronic spinal cord injury patients. Cell Transplant. 2014 Apr;23(6):729-45. doi: 10.3727/096368913X664540. Epub 2013 Feb 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 2, 2009)
80
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 36 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00816803
Other Study ID Numbers  ICMJE EGY-SCI-1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hatem E. Sabaawy, M, PhD, Assistant Professor of Medicine, Cairo University, and the Cancer Institute of New Jersey, UMDNJ/RWJMS
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE
  • Al-Azhar University
  • Medical Military Academy, Egypt
  • Alexandria University
Investigators  ICMJE Not Provided
PRS Account Cairo University
Verification Date January 2009

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