NCT01446640

Mesenchymal Stem Cells Transplantation to Patients With Spinal Cord Injury

PhaseⅠ/ⅡTrial of Autologous Bone Marrow Derived Mesenchymal Stem Cells to Patients With Spinal Cord Injury.

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Guangzhou General Hospital of Guangzhou Military Command · Academic / Other
• Sex: All
• Age: 16 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The study is a phase I/II trial designed to establish the safety and efficacy of intravenous combined with intrathecal administration of autologous bone marrow derived mesenchymal stem cells to patients with spinal cord injury.

Detailed description

Spinal cord injury (SCI) is a traumatic disorder resulting in a functional deficit that usually leads to severe and permanent paralysis. Pharmacological and rehabilitation therapies to SCI get limited effect. Another promising therapeutic approaches for SCI is cellular transplantation. Cell types used in SCI therapy include Schwann cells, olfactory ensheathing cells and adult stem cells, such as neural stem cells, umbilical cord blood derived cells, mesenchymal stem cells (MSCs) or induced pluripotent stem cells. There are not yet conclusive evidences on which types of glial or adult stem cells are most effective in SCI treatment. MSC have been shown to promote anatomical and functional recovery in animal models of SCI by promoting tissue sparing ,axonal regeneration, and remyelination. Therapeutic effects of MSCs are primarily due to the secretion of soluble factors and the provision of extracellular matrix that provide protection and support repair. MSC are attractive candidates for transplantation into human patients because they can be easily harvested, expanded and banked, or derived directly from the patient allowing for autologous transplantation, obviating the need for immune suppression. The clinical translation of cellular transplantation strategies requires a safe and efficient means of cellular delivery. In animal models of SCI, the most common delivery is direct injection into the injury site, which allows a defined number of cells to be delivered, but risks further injuring the cord. Less invasive methods for cell delivery have been investigated, including intravascular delivery (intravenous (IV) and intra-arterial) and delivery into the cerebrospinal fluid (intrathecal). These minimally-invasive techniques decrease the risk to the patient and allow delivery of multiple cell doses. Maybe intrathecal administration is superior to IV delivery, cell engraftment and tissue sparing were significantly better after intrathecal delivery, but more researches are needed for get conclusion.

Conditions

• Spinal Cord Injury

Interventions

Type	Name	Description
BIOLOGICAL	bone marrow derived mesenchymal stem cells	Intravenous administration of up to 1x10\^6 MSCs per kg; intrathecal administration of up to 1x10\^6 MSCs per kg.

Timeline

• Start date: 2011-10-01
• Primary completion: 2013-06-01
• Completion: 2014-06-01
• First posted: 2011-10-05
• Last updated: 2011-10-05

Locations

1 site across 1 country: China