Safety of Autologous Adipose Derived Mesenchymal Stem Cells in Patients With Spinal Cord Injury

R-Bio0 sites8 target enrollmentJuly 2009

ConditionsSpinal Cord Injury

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Spinal Cord Injury
Sponsor: R-Bio
Enrollment: 8
Primary Endpoint: safety evaluation
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This study is designed to assess the safety of intravenous autologous adipose derived mesenchymal stem cells transplant in spinal cord injury patients.

Detailed Description

Adipose derived mesenchymal stem cells (AdMSCs) represent an attractive and ethical cell source for stem cell therapy. With the recent demonstration of MSC homing properties, intravenous aplications of MSCs to cell-damaged diseases have increased. In a human clinical trial, eight male patients who had suffered a spinal cord injury were intravenously administered autologous hAdMSCs (4×10e8 cells) one time.

Registry

clinicaltrials.gov

Start Date

July 2009

End Date

February 2010

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

R-Bio

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects who understand and sign the consent form for this study.
•Age :19-60, males
•Clinical diagnosis of spinal cord injury(American Spinal Injury Association\[ASIA\] Impairment Scale\[AIS\] grade A or B or C)
•Duration of injury : \> 2 months

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 who has high body temperature more than 38℃ or acute disorder
•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
•Subjects with muscular dystrophy or articular rigidity
•Patients with clouded consciousness or speech disorder