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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RNL-Vascostem® | Experimental | drug name and ingredients : RNL-Vascostem[Autologous adipose tissue derived mesenchymal stem cells] dosage : Intramuscular infusion, 5 x 10e6 cells/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RNL-Vascostem® | Biological |
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| Measure | Description | Time Frame |
|---|---|---|
| Treadmill Walking Distance | Improvement in TWD(Treadmill Walking Distance) | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| VAS(Visual Analog Scale) | Improvement in VAS(Visual Analog Scale) score | 24 weeks |
| Toe-Brachial Pressure Index, TBPI | Improvement in TBPI score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sang-Hong Baek, M.D.&Ph.D. | Seoul St. Mary's Hospital | Principal Investigator |
| Eui Cheol Jeong, M.D. | SMG-SNU Boramae Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul St. Mary's Hospital | Seoul | South Korea | ||||
| SMG-SNU Boramae Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22498564 | Result | Lee HC, An SG, Lee HW, Park JS, Cha KS, Hong TJ, Park JH, Lee SY, Kim SP, Kim YD, Chung SW, Bae YC, Shin YB, Kim JI, Jung JS. Safety and effect of adipose tissue-derived stem cell implantation in patients with critical limb ischemia: a pilot study. Circ J. 2012;76(7):1750-60. doi: 10.1253/circj.cj-11-1135. Epub 2012 Apr 12. |
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| ID | Term |
|---|---|
| D013919 | Thromboangiitis Obliterans |
| ID | Term |
|---|---|
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D014657 | Vasculitis |
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| 24 weeks |
| Transcutaneous oxygen pressure, TcPO2 | Improvement in TcPO2 score | 24 weeks |
| Arterial Brachial Pressure Index, ABPI | Improvement in ABPI score | 24 weeks |
| Pain Free Walking Distance, PFWD | Improvement in PFWD score | 24 weeks |
| Angiography | Improvement on Angiography | 24 weeks |
| Laser Doppler | Improvement on Laser Doppler | 24 weeks |
| dose and frequency in use of a analgesic medicine | Changes in dose and frequency in use of a analgesic medicine | 24 weeks |
| Safety Evaluation | 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 | 24 weeks |
| Seoul |
| South Korea |