Cell Transplant in Spinal Cord Injury Patients
Primary Purpose
Chronic Spinal Cord Injury
Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Autologous bone marrow transplant
Physical therapy
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Spinal Cord Injury focused on measuring Spinal cord injury
Eligibility 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
Sites / Locations
- Cairo University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
BM transplant with physiotherapy
Physiotherapy only
Arm Description
Autologous BM transplant
conventional physical therapy for chronic spinal cord injury.
Outcomes
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.
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.
Full Information
NCT ID
NCT00816803
First Posted
December 31, 2008
Last Updated
January 2, 2009
Sponsor
Cairo University
Collaborators
Al-Azhar University, Medical Military Academy, Egypt, Alexandria University
1. Study Identification
Unique Protocol Identification Number
NCT00816803
Brief Title
Cell Transplant in Spinal Cord Injury Patients
Official Title
Autologous Bone Marrow Derived Cell Transplant in Spinal Cord Injury Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Cairo University
Collaborators
Al-Azhar University, Medical Military Academy, Egypt, Alexandria University
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Spinal Cord Injury
Keywords
Spinal cord injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BM transplant with physiotherapy
Arm Type
Experimental
Arm Description
Autologous BM transplant
Arm Title
Physiotherapy only
Arm Type
Active Comparator
Arm Description
conventional physical therapy for chronic spinal cord injury.
Intervention Type
Procedure
Intervention Name(s)
Autologous bone marrow transplant
Intervention Type
Procedure
Intervention Name(s)
Physical therapy
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
36 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Cairo University School of Medicine
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
23452836
Citation
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.
Results Reference
derived
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Cell Transplant in Spinal Cord Injury Patients
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