Cell Transplant in Spinal Cord Injury Patients

Cairo University (CU)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Chronic Spinal Cord Injury

Treatments: Procedure: Physical therapy; Procedure: Autologous bone marrow transplant

Study type: Interventional

Funder types: Other

Identifiers

NCT00816803

EGY-SCI-1

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 10 to 36 years old

Volunteers: No Healthy Volunteers

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

Trial design

80 participants in 2 patient groups

BM transplant with physiotherapy

Experimental group

Description:

Autologous BM transplant

Treatment:

Procedure: Autologous bone marrow transplant

Procedure: Physical therapy

Physiotherapy only

Active Comparator group

Description:

conventional physical therapy for chronic spinal cord injury.

Treatment:

Procedure: Physical therapy