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

Biostar Stem Cell Research Institute (R-Bio)

Status and phase

Completed

Phase 2

Phase 1

Conditions

Spinal Cord Injury

Treatments

Procedure: Autologous Adipose Tissue derived MSCs Transplantation

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01769872

KSC-MSCs-SPI

Details and patient eligibility

About

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

Enrollment

15 patients

Sex

All

Ages

19 to 70 years old

Volunteers

No Healthy Volunteers

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
other serious disease or disorder that could seriously affect ability to participate in the study