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 range
20 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.