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

Phase 1

Completed

• Conditions: Spinal Cord Injury
• Interventions: Procedure: Autologous Adipose Tissue derived MSCs Transplantation

• Registration Number: NCT01769872
• Lead Sponsor: R-Bio

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-15
• Study First Submitted QC: 2013-01-15
• Study First Posted: 2013-01-17
• Primary Completion: 2016-01
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-01
• Last Update Posted: 2016-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Autologous Adipose Tissue derived MSCs	Autologous Adipose Tissue derived MSCs Transplantation	-

Primary Outcome Measures

Name	Time	Method
ASIA (American Spinal Injury Association) scale	32 weeks	To evaluate the change of treated spinal cord before cell implantation and at 3 and 6 months post injection of MSCs.

Secondary Outcome Measures

Name	Time	Method
Magnetic Resonance Imaging	32 weeks	To evaluate the change of treated spinal cord injury using Magnetic Resonance Imaging (MRI) at 3 and 6 months post injection of MSCs.
SF-36	32 weeks	To evaluate the change of treated spinal cord before cell implantation and at 3 and 6 months post injection of MSCs.
MEP/SSEP	32 weeks	To evaluate the change of treated spinal cord before cell implantation and at 3 and 6 months post injection of MSCs.
ADL (activities of daily living)	32 weeks	To evaluate the change of treated spinal cord before cell implantation and at 3 and 6 months post injection of MSCs.
ODI (Oswestry Disability Questionnaire)	32 weeks	To evaluate the change of treated spinal cord before cell implantation and at 3 and 6 months post injection of MSCs.
Frequency of Adverse Events	32 weeks

Trial Locations

Locations (1)

Korea University Anam Hospital; 🇰🇷 Seoul, Korea, Republic of