Cell Transplant in Spinal Cord Injury Patients
Autologous Bone Marrow Derived Cell Transplant in Spinal Cord Injury Patients
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2005
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 31, 2008
CompletedFirst Posted
Study publicly available on registry
January 5, 2009
CompletedJanuary 5, 2009
January 1, 2009
3.6 years
December 31, 2008
January 2, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
18 months
Secondary Outcomes (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.
18 months
Study Arms (2)
BM transplant with physiotherapy
EXPERIMENTALAutologous BM transplant
Physiotherapy only
ACTIVE COMPARATORconventional physical therapy for chronic spinal cord injury.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
- Al-Azhar Universitycollaborator
- Medical Military Academy, Egyptcollaborator
- Alexandria Universitycollaborator
Study Sites (1)
Cairo University School of Medicine
Cairo, Egypt
Related Publications (1)
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.
PMID: 23452836DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 31, 2008
First Posted
January 5, 2009
Study Start
May 1, 2005
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
January 5, 2009
Record last verified: 2009-01