Clinical trial NCT01302015: 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
Overall status: COMPLETED
Phase: NA
Conditions: Buerger's Disease
Lead sponsor: R-Bio
Sponsor class: INDUSTRY
First posted: 2011-02-23
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Treadmill Walking Distance
timeFrame: 24 weeks
Secondary outcomes:
measure: VAS(Visual Analog Scale)
timeFrame: 24 weeks
measure: Toe-Brachial Pressure Index, TBPI
timeFrame: 24 weeks
measure: Transcutaneous oxygen pressure, TcPO2
timeFrame: 24 weeks
measure: Arterial Brachial Pressure Index, ABPI
timeFrame: 24 weeks
measure: Pain Free Walking Distance, PFWD
timeFrame: 24 weeks
measure: Angiography
timeFrame: 24 weeks
measure: Laser Doppler
timeFrame: 24 weeks
measure: dose and frequency in use of a analgesic medicine
timeFrame: 24 weeks
measure: Safety Evaluation
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Sang-Hong Baek, M.D.&Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: SMG-SNU Boramae Medical Center
name: Eui Cheol Jeong, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.