Cell Transplant in Spinal Cord Injury Patients - Full Text View

Sponsors and Collaborators:	Cairo University Alazhar University, Egypt Medical Military Academy, Egypt Alexandria University, Egypt
Information provided by:	Cairo University
ClinicalTrials.gov Identifier:	NCT00816803

Purpose

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	Intervention	Phase
Chronic Spinal Cord Injury	Procedure: Autologous bone marrow transplant Procedure: Physical therapy	Phase I Phase II

MedlinePlus related topics: Spinal Cord Injuries

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Autologous Bone Marrow Derived Cell Transplant in Spinal Cord Injury Patients

Further study details as provided by Cairo University:

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. [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

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. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment:	80
Study Start Date:	May 2005
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
BM transplant with physiotherapy: Experimental Autologous BM transplant	Procedure: Autologous bone marrow transplant Procedure: Physical therapy
Physiotherapy only: Active Comparator conventional physical therapy for chronic spinal cord injury.	Procedure: Physical therapy

Eligibility

Ages Eligible for Study:	10 Years to 36 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00816803

Locations

Egypt
Cairo University School of Medicine
Cairo, Egypt

Sponsors and Collaborators

Cairo University

Alazhar University, Egypt

Medical Military Academy, Egypt

Alexandria University, Egypt

More Information

Responsible Party:	Cairo University, and the Cancer Institute of New Jersey, UMDNJ/RWJMS ( Hatem E. Sabaawy, M, PhD, Assistant Professor of Medicine )
Study ID Numbers:	EGY-SCI-1
Study First Received:	December 31, 2008
Last Updated:	January 2, 2009
ClinicalTrials.gov Identifier:	NCT00816803
Health Authority:	Egypt: Ministry of Health and Population

Keywords provided by Cairo University:

Spinal cord injury

Study placed in the following topic categories:

Spinal Cord Injuries
Spinal Cord Diseases
Wounds and Injuries

Disorders of Environmental Origin
Central Nervous System Diseases
Trauma, Nervous System

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 13, 2009