Buerger's Disease
Conditions
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.
Interventions
BIOLOGICALRNL-Vascostem®
Sponsors
R-Bio
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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. * Women who are pregnant or breast feeding or planning to become pregnant during the study. * Subjects who have cerebrovascular accident within 6 months prior to inclusion in the study. * Patients with acute myocardial infarction, angina pectoris. * Subjects who had been underwent a cardiovascular surgery such as carotid endarterectomy, arterial aneurysm, bypass surgery and coronary bypass surgery within 3 months prior to inclusion in the study. * Participation in another clinical trial or treatment with a different investigational product within 3 months prior to inclusion in the study. * Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treadmill Walking Distance | 24 weeks | Improvement in TWD(Treadmill Walking Distance) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VAS(Visual Analog Scale) | 24 weeks | Improvement in VAS(Visual Analog Scale) score |
| Toe-Brachial Pressure Index, TBPI | 24 weeks | Improvement in TBPI score |
| Transcutaneous oxygen pressure, TcPO2 | 24 weeks | Improvement in TcPO2 score |
| Arterial Brachial Pressure Index, ABPI | 24 weeks | Improvement in ABPI score |
| Pain Free Walking Distance, PFWD | 24 weeks | Improvement in PFWD score |
| Angiography | 24 weeks | Improvement on Angiography |
| Laser Doppler | 24 weeks | Improvement on Laser Doppler |
| dose and frequency in use of a analgesic medicine | 24 weeks | Changes in dose and frequency in use of a analgesic medicine |
| Safety Evaluation | 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 |
Countries
South Korea
Outcome results
None listed