Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Buerger'… (NCT01302015) | Clinical Trial Compass
CompletedNot Applicable
Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Buerger's Disease
South Korea15 participantsStarted 2007-12
Plain-language 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.
Who can participate
Age range20 Years – 80 Years
SexALL
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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 …