Safety and Efficacy of Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Buerger's Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Buerger's Disease
- Sponsor
- R-Bio
- Enrollment
- 15
- Locations
- 2
- Primary Endpoint
- Treadmill Walking Distance
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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 Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects who understand and sign the consent form for this study.
- •Age :20-80, males and females
- •Patients at least 6 months after Buerger's disease
- •Patients with a luminal stenosis of more than 50% on angiography
- •Rutherford class II-4, III-5 or III-6
- •Subjects not eligible to undergo a revascularization or vascular bypass graft
- •Patients who can't treat with traditional medication and need a arthroplasty.
- •Patients whose lesion is 2\~6 cm2 in size
- •Duration of pain over Grade 4(11-point numeric scale) : \> 4 months
Exclusion Criteria
- •Subjects who cannot survive more than 6 months with critical other complications.
- •Patient with well-known active malignant tumor.
- •Patients who exceed normal reference values from following test : PAP smear screening, chest X-ray, PSA, mammogram, occult blood test
- •Patients in need of a immediate amputation and have a potentially life-threatening complications of critical ischemia
- •Patients with uncontrolled iliac artery obstruction of targeted areas.
- •Condition with targeted lower limb that have widespread necrosis or in need of amputation.
- •End-stage renal failure patients who depend on hemodialysis
- •Patients with uncontrolled diabetes mellitus (HbA1c \> 10%).
- •Treatment with immunosuppressant (prednisone \> 5mg/day).
- •Treatment with a anti-inflammatory drugs within 1 weeks prior to enrollment.
Outcomes
Primary Outcomes
Treadmill Walking Distance
Time Frame: 24 weeks
Improvement in TWD(Treadmill Walking Distance)
Secondary Outcomes
- VAS(Visual Analog Scale)(24 weeks)
- Angiography(24 weeks)
- Arterial Brachial Pressure Index, ABPI(24 weeks)
- Toe-Brachial Pressure Index, TBPI(24 weeks)
- Transcutaneous oxygen pressure, TcPO2(24 weeks)
- Pain Free Walking Distance, PFWD(24 weeks)
- Safety Evaluation(24 weeks)
- Laser Doppler(24 weeks)
- dose and frequency in use of a analgesic medicine(24 weeks)