Trial | NCT01302015  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    15
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.
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.
Study Started
Dec 31
2007
Primary Completion
Dec 31
2013
Study Completion
Dec 31
2013
Last Update
Jun 05
2019

Biological RNL-Vascostem®

  • Other names: Autologous adipose tissue derived mesenchymal stem cells

RNL-Vascostem® Experimental

drug name and ingredients : RNL-Vascostem[Autologous adipose tissue derived mesenchymal stem cells] dosage : Intramuscular infusion, 5 x 10e6 cells/kg

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.
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
No Results Posted