Safety and Effect of Adipose Tissue Derived Mesenchymal Stem Cell Implantation in Patients With Spinal Cord Injury

R-Bio1 site in 1 country15 target enrollmentJanuary 2013

ConditionsSpinal Cord Injury

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Spinal Cord Injury
Sponsor: R-Bio
Enrollment: 15
Locations: 1
Primary Endpoint: ASIA (American Spinal Injury Association) scale
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with spinal cord injury

Registry

clinicaltrials.gov

Start Date

January 2013

End Date

January 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

R-Bio

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects who understand and sign the consent form for this study
•Age : 19-70
•Clinical diagnosis of spinal cord injury(American Spinal Injury Association\[ASIA\] Impairment Scale\[AIS\] grade A or B or C)
•Duration of injury : \> 3 month

Exclusion Criteria

•Subjects who must put on a respirator
•Subjects who had malignant tumor within 5 years
•Subjects with a infectious disease include HIV and hepatitis
•Subjects who injured brain or spinal cord before spinal cord injury
•Subjects with anemia or thrombocytopenia
•Subjects with angina pectoris, myocardial infarction, cardiomyopathy, occlusive disease, chronic renal failure, glomerular disease and chronic obstructive pulmonary disease
•Subjects with congenital or acquired immunodeficiency disorders
•Patients with clouded consciousness or speech disorder
•treat with cytotoxic medications(immunosuppressive drug, corticosteroid and cytotoxic drug) during clinical trials
•participating another clinical trials within 3 months