Cell Transplant in Spinal Cord Injury Patients

• Sponsor: Cairo University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00816803
• Collaborator: Al-Azhar University (Other), Medical Military Academy, Egypt (Other), Alexandria University (Other)
• Enrollment: 80
• Location: 1
• Arms: 2
• Duration (Months): 43
• Patients Per Site Per Month: 1.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Spinal Cord Injury	Procedure: Autologous bone marrow transplant; Procedure: Physical therapy	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Autologous Bone Marrow Derived Cell Transplant in Spinal Cord Injury Patients
• Study Start Date: May 1, 2005
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Dec 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BM transplant with physiotherapy Autologous BM transplant	Procedure: Autologous bone marrow transplant; Procedure: Physical therapy
Active Comparator: Physiotherapy only conventional physical therapy for chronic spinal cord injury.	Procedure: Physical therapy

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years to 36 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Cairo University School of Medicine	Cairo		Egypt

Sponsors and Collaborators

• Cairo University
• Al-Azhar University
• Medical Military Academy, Egypt
• Alexandria University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00816803
• Other Study ID Numbers: EGY-SCI-1
• First Posted: Jan 5, 2009
• Last Update Posted: Jan 5, 2009
• Last Verified: Jan 1, 2009

• Keywords provided by , ,: Spinal cord injury
• Additional relevant MeSH terms: Spinal Cord Injuries; Wounds and Injuries

Study Results

No Results Posted as of Jan 5, 2009