NCT01676441

Safety and Efficacy of Autologous Mesenchymal Stem Cells in Chronic Spinal Cord Injury

A Phase II/III Clinical Trial to Evaluate the Safety and Efficacy of Bone Marrow-derived Mesenchymal Stem Cell Transplantation in Patients With Chronic Spinal Cord Injury.

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Pharmicell Co., Ltd. · Industry
• Sex: All
• Age: 16 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This phase II/III clinical trial is designed to evaluate the safety and efficacy of autologous Mesenchymal Stem Cells (MSC) transplanted directly into the injured spinal cord.

Detailed description

The Principal investigator has performed a clinical trial using autologous MSCs in patients with cervical spinal cord injury. The results revealed the safety of autologous MSC. This Phase II, III single-center trial is to assess the safety and efficacy of bone marrow-derived mesenchymal stem cell transplantation direct to injured spinal cord site via laminectomy. After recovery from the operation, the subjects receive 4 weeks of physical and occupational therapy.

Conditions

• Spinal Cord Injury

Interventions

Type	Name	Description
DRUG	cellgram-spine	Mesenchymal stem cells transplantation

Timeline

• Start date: 2008-08-01
• Primary completion: 2021-03-04
• Completion: 2021-03-04
• First posted: 2012-08-31
• Last updated: 2021-03-23

Locations

1 site across 1 country: South Korea