Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Buerger's Disease
Primary Purpose
Buerger's Disease
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
RNL-Vascostem®
Sponsored by
About this trial
This is an interventional treatment trial for Buerger's Disease
Eligibility 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
Sites / Locations
- Seoul St. Mary's Hospital
- SMG-SNU Boramae Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
RNL-Vascostem®
Arm Description
drug name and ingredients : RNL-Vascostem[Autologous adipose tissue derived mesenchymal stem cells] dosage : Intramuscular infusion, 5 x 10e6 cells/kg
Outcomes
Primary Outcome Measures
Treadmill Walking Distance
Improvement in TWD(Treadmill Walking Distance)
Secondary Outcome Measures
VAS(Visual Analog Scale)
Improvement in VAS(Visual Analog Scale) score
Toe-Brachial Pressure Index, TBPI
Improvement in TBPI score
Transcutaneous oxygen pressure, TcPO2
Improvement in TcPO2 score
Arterial Brachial Pressure Index, ABPI
Improvement in ABPI score
Pain Free Walking Distance, PFWD
Improvement in PFWD score
Angiography
Improvement on Angiography
Laser Doppler
Improvement on Laser Doppler
dose and frequency in use of a analgesic medicine
Changes in dose and frequency in use of a analgesic medicine
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01302015
Brief Title
Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Buerger's Disease
Official Title
Safety and Efficacy of Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Buerger's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
R-Bio
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Buerger's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RNL-Vascostem®
Arm Type
Experimental
Arm Description
drug name and ingredients : RNL-Vascostem[Autologous adipose tissue derived mesenchymal stem cells] dosage : Intramuscular infusion, 5 x 10e6 cells/kg
Intervention Type
Biological
Intervention Name(s)
RNL-Vascostem®
Other Intervention Name(s)
Autologous adipose tissue derived mesenchymal stem cells
Primary Outcome Measure Information:
Title
Treadmill Walking Distance
Description
Improvement in TWD(Treadmill Walking Distance)
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
VAS(Visual Analog Scale)
Description
Improvement in VAS(Visual Analog Scale) score
Time Frame
24 weeks
Title
Toe-Brachial Pressure Index, TBPI
Description
Improvement in TBPI score
Time Frame
24 weeks
Title
Transcutaneous oxygen pressure, TcPO2
Description
Improvement in TcPO2 score
Time Frame
24 weeks
Title
Arterial Brachial Pressure Index, ABPI
Description
Improvement in ABPI score
Time Frame
24 weeks
Title
Pain Free Walking Distance, PFWD
Description
Improvement in PFWD score
Time Frame
24 weeks
Title
Angiography
Description
Improvement on Angiography
Time Frame
24 weeks
Title
Laser Doppler
Description
Improvement on Laser Doppler
Time Frame
24 weeks
Title
dose and frequency in use of a analgesic medicine
Description
Changes in dose and frequency in use of a analgesic medicine
Time Frame
24 weeks
Title
Safety Evaluation
Description
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
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang-Hong Baek, M.D.&Ph.D.
Organizational Affiliation
Seoul St. Mary's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eui Cheol Jeong, M.D.
Organizational Affiliation
SMG-SNU Boramae Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
SMG-SNU Boramae Medical Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
22498564
Citation
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.
Results Reference
result
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Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Buerger's Disease
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