Cell Transplant in Spinal Cord Injury Patients

Chronic Spinal Cord Injury Clinical Trial

Official title:

Autologous Bone Marrow Derived Cell Transplant in Spinal Cord Injury Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00816803
• Other study ID #: EGY-SCI-1
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 31, 2008
• Last updated: January 2, 2009
• Start date: May 2005
• Est. completion date: December 2008

Study information

• Verified date: January 2009
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and Population
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 36 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Spinal Cord Injury
• Spinal Cord Injuries

Intervention

Procedure:
• Autologous bone marrow transplant

• Physical therapy

Locations

Country	Name	City	State
Egypt	Cairo University School of Medicine	Cairo

Sponsors (4)

Lead Sponsor	Collaborator
Cairo University	Al-Azhar University, Alexandria University, Medical Military Academy, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No