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Umbilical Cord Mesenchymal Stem Cells Transplantation to Patients With Spinal Cord Injury

2015-06-26 06:23:23 | BioPortfolio

Summary

The purpose of this study is to evaluate the safety and efficacy of intrathecal administration of allogeneic umbilical cord derived mesenchymal stem cells to patients with spinal cord injury.

Description

Spinal cord injury(SCI) is a common severe traumatic central nervous system damage. And now the treatment of SCI is still a worldwide problem in clinic. How to improve the curative effect of SCI and restore the limb nerve function as far as possible are becoming the key problems in the clinical treatment of SCI. The current treatments for spinal cord injury mainly include surgical treatment, medical therapy, physical therapy, preventing the complications after injury, but these treatments can only make some clinical improvement in patients, most patients will also face severe nerve dysfunction. Animal experiments and clinical researches in recent years have reported using umbilical cord mesenchymal stem cells (UC-MSCs) transplantation to treat spinal cord injury, this provides a new approach of SCI treatment, but its efficacy remains controversial, and lacking of high credible prospective cohort clinical trial evidence to support.

In this study, completely or incompletely cervical, thoracic spinal cord injury participants were recruited to join in a prospective, cohort clinical trials. Intervention is subarachnoid injection of human allogeneic UC-MSCs and the main evaluation index is American spinal injury association (ASIA) score, secondary evaluation indicator is electromyogram and electroneurophysiologic test.

A monocenter prospective cohort study will be performed to evaluate the effectiveness of UC-MSCs, for the treatment of completely or incompletely spinal cord injury. The primary outcome is American spinal injury association (ASIA) score at baseline, 1 month, 3 months, 6 months, 12 and 24 months post-treatment. Secondary outcomes of the study include the number of participants with adverse events at 1 month post-treatment, electromyogram and electroneurophysiologic test at baseline, 1 month, 3 months, 6 months, 12 and 24 months post-treatment.

On the basis of the results of this trial investigators will, for the first time, have scientific evidence as to the relative safety and efficacy of UC-MSCs transplantation for the treatment of spinal cord injury.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Nerve and Spinal Cord Injuries

Intervention

Umbilical Cord Mesenchymal Stem Cells

Location

the Third Affiliated Hospital of Sun Yat-Sen University
Guangzhou
Guangdong
China
510630

Status

Recruiting

Source

Third Affiliated Hospital, Sun Yat-Sen University

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-06-26T06:23:23-0400

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Suppression of miR-10a-5p in bone marrow mesenchymal stem cells enhances the therapeutic effect on spinal cord injury via BDNF.

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Medical and Biotech [MESH] Definitions

Bone-marrow-derived, non-hematopoietic cells that support HEMATOPOETIC STEM CELLS. They have also been isolated from other organs and tissues such as UMBILICAL CORD BLOOD, umbilical vein subendothelium, and WHARTON JELLY. These cells are considered to be a source of multipotent stem cells because they include subpopulations of mesenchymal stem cells.

Transplantation of STEM CELLS collected from the fetal blood remaining in the UMBILICAL CORD and the PLACENTA after delivery. Included are the HEMATOPOIETIC STEM CELLS.

Neoplasms located in the space between the vertebral PERIOSTEUM and DURA MATER surrounding the SPINAL CORD. Tumors in this location are most often metastatic in origin and may cause neurologic deficits by mass effect on the spinal cord or nerve roots or by interfering with blood supply to the spinal cord.

Pathologic conditions which feature SPINAL CORD damage or dysfunction, including disorders involving the meninges and perimeningeal spaces surrounding the spinal cord. Traumatic injuries, vascular diseases, infections, and inflammatory/autoimmune processes may affect the spinal cord.

Repair of the damaged neuron function after SPINAL CORD INJURY or SPINAL CORD DISEASES.

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