Autologous Adipose Derived MSCs Transplantation in Patient With Spinal Cord Injury.

Phase 1

Completed

• Conditions: Spinal Cord Injury

• Registration Number: NCT01274975
• Lead Sponsor: R-Bio

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.

Study Timeline

• Study Start: 2009-07
• Primary Completion: 2009-11
• Study Completion: 2010-02
• Study First Submitted: 2011-01-06
• Study First Submitted QC: 2011-01-11
• Study First Posted: 2011-01-12
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-24
• Last Update Posted: 2014-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

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
• 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

Primary Outcome Measures

Name	Time	Method
safety evaluation	12weeks	Safety evaluate through physical examination, vital sign and laboratory test after "RNL-Astrostem" injected