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 Buerger's disease.
Buerger's disease, also known as thromboangiitis obliterans, is a rare disorder that, in most cases, affects young or middle-aged male cigarette smokers. It is characterized by narrowing or blockage (occlusion) of the veins and arteries of the extremities, resulting in reduced blood flow to these areas (peripheral vascular disease). The exact cause of Buerger's disease is not known; however, most affected individuals are heavy tobacco users. This drug is an autologous cell treatment for necrosis in the legs of patients with Beurger's diseases to improve symptoms through vascular regeneration.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Seoul St. Mary's Hospital
Seoul, South Korea
SMG-SNU Boramae Medical Center
Seoul, South Korea
Treadmill Walking Distance
Improvement in TWD(Treadmill Walking Distance)
Time frame: 24 weeks
VAS(Visual Analog Scale)
Improvement in VAS(Visual Analog Scale) score
Time frame: 24 weeks
Toe-Brachial Pressure Index, TBPI
Improvement in TBPI score
Time frame: 24 weeks
Transcutaneous oxygen pressure, TcPO2
Improvement in TcPO2 score
Time frame: 24 weeks
Arterial Brachial Pressure Index, ABPI
Improvement in ABPI score
Time frame: 24 weeks
Pain Free Walking Distance, PFWD
Improvement in PFWD score
Time frame: 24 weeks
Angiography
Improvement on Angiography
Time frame: 24 weeks
Laser Doppler
Improvement on Laser Doppler
Time frame: 24 weeks
dose and frequency in use of a analgesic medicine
Changes in dose and frequency in use of a analgesic medicine
Time frame: 24 weeks
Safety Evaluation
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To determine the overall safety of RNL-VascoStem® carrier using physical examinations, vital signs, treatment emergent adverse events (TEAEs), and the results of clinical lab tests
Time frame: 24 weeks