Clinical Trial: Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Buerger's Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Safety and Efficacy of Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Buerger's Disease

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 Buerger's disease.

Detailed Summary:

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.


Sponsor: Biostar

Current Primary Outcome: Treadmill Walking Distance [ Time Frame: 24 weeks ]

Improvement in TWD(Treadmill Walking Distance)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • VAS(Visual Analog Scale) [ Time Frame: 24 weeks ]
    Improvement in VAS(Visual Analog Scale) score
  • Toe-Brachial Pressure Index, TBPI [ Time Frame: 24 weeks ]
    Improvement in TBPI score
  • Transcutaneous oxygen pressure, TcPO2 [ Time Frame: 24 weeks ]
    Improvement in TcPO2 score
  • Arterial Brachial Pressure Index, ABPI [ Time Frame: 24 weeks ]
    Improvement in ABPI score
  • Pain Free Walking Distance, PFWD [ Time Frame: 24 weeks ]
    Improvement in PFWD score
  • Angiography [ Time Frame: 24 weeks ]
    Improvement on Angiography
  • Laser Doppler [ Time Frame: 24 weeks ]
    Improvement on Laser Doppler
  • dose and frequency in use of a analgesic medicine [ Time Frame: 24 weeks ]
    Changes in dose and frequency in use of a analgesic medicine
  • Safety Evaluation [ Time Frame: 24 weeks ]
    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


Original Secondary Outcome: Same as current

Information By: Biostar

Dates:
Date Received: February 17, 2011
Date Started: December 2007
Date Completion:
Last Updated: March 24, 2014
Last Verified: March 2014