Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Buerger's Disease
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ClinicalTrials.gov Identifier: NCT01302015 |
Recruitment Status :
Completed
First Posted : February 23, 2011
Last Update Posted : June 5, 2019
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Condition or disease | Intervention/treatment | Phase |
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Buerger's Disease | Biological: RNL-Vascostem® | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 15 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Safety and Efficacy of Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Buerger's Disease |
Study Start Date : | December 2007 |
Actual Primary Completion Date : | December 2013 |
Actual Study Completion Date : | December 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: RNL-Vascostem®
drug name and ingredients : RNL-Vascostem[Autologous adipose tissue derived mesenchymal stem cells] dosage : Intramuscular infusion, 5 x 10e6 cells/kg
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Biological: RNL-Vascostem®
Other Name: Autologous adipose tissue derived mesenchymal stem cells |
- Treadmill Walking Distance [ Time Frame: 24 weeks ]Improvement in TWD(Treadmill Walking Distance)
- VAS(Visual Analog Scale) [ Time Frame: 24 weeks ]Improvement in VAS(Visual Analog Scale) score
- Toe-Brachial Pressure Index, TBPI [ Time Frame: 24 weeks ]Improvement in TBPI score
- Transcutaneous oxygen pressure, TcPO2 [ Time Frame: 24 weeks ]Improvement in TcPO2 score
- Arterial Brachial Pressure Index, ABPI [ Time Frame: 24 weeks ]Improvement in ABPI score
- Pain Free Walking Distance, PFWD [ Time Frame: 24 weeks ]Improvement in PFWD score
- Angiography [ Time Frame: 24 weeks ]Improvement on Angiography
- Laser Doppler [ Time Frame: 24 weeks ]Improvement on Laser Doppler
- dose and frequency in use of a analgesic medicine [ Time Frame: 24 weeks ]Changes in dose and frequency in use of a analgesic medicine
- Safety Evaluation [ Time Frame: 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

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Ages Eligible for Study: | 20 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01302015
Korea, Republic of | |
Seoul St. Mary's Hospital | |
Seoul, Korea, Republic of | |
SMG-SNU Boramae Medical Center | |
Seoul, Korea, Republic of |
Principal Investigator: | Sang-Hong Baek, M.D.&Ph.D. | Seoul St. Mary's Hospital | |
Principal Investigator: | Eui Cheol Jeong, M.D. | SMG-SNU Boramae Medical Center |
Responsible Party: | R-Bio |
ClinicalTrials.gov Identifier: | NCT01302015 |
Other Study ID Numbers: |
Vascostem |
First Posted: | February 23, 2011 Key Record Dates |
Last Update Posted: | June 5, 2019 |
Last Verified: | June 2019 |
Thromboangiitis Obliterans Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Vasculitis |