Cell Transplant in Spinal Cord Injury Patients

Phase 1

Completed

• Conditions: Chronic Spinal Cord Injury
• Interventions: Procedure: Autologous bone marrow transplant; Procedure: Physical therapy

• Registration Number: NCT00816803
• Lead Sponsor: Cairo University

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 available

Study Timeline

• Study Start: 2005-05
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Study First Submitted: 2008-12-31
• Status Verified: 2009-01
• Study First Submitted QC: 2009-01-02
• Last Update Submitted: 2009-01-02
• Study First Posted: 2009-01-05
• Last Update Posted: 2009-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BM transplant with physiotherapy	Autologous bone marrow transplant	Autologous BM transplant
BM transplant with physiotherapy	Physical therapy	Autologous BM transplant
Physiotherapy only	Physical therapy	conventional physical therapy for chronic spinal cord injury.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Cairo University School of Medicine; 🇪🇬 Cairo, Egypt