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

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.

Study Overview

• Status: Completed
• Conditions: Buerger's Disease
• Intervention / Treatment: Biological: RNL-Vascostem®

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul st. mary's hospital
  • Seoul, Korea, Republic of
    • SMG-SNU Boramae Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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	Biological: RNL-Vascostem®; Other Names: Autologous adipose tissue derived mesenchymal stem cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treadmill Walking Distance	Improvement in TWD(Treadmill Walking Distance)	24 weeks

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: R-Bio
• Investigators: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: February 17, 2011
• First Submitted That Met QC Criteria: February 20, 2011
• First Posted (Estimate): February 23, 2011

Study Record Updates

• Last Update Posted (Actual): June 5, 2019
• Last Update Submitted That Met QC Criteria: June 3, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases; Vasculitis; Thromboangiitis Obliterans
• Other Study ID Numbers: Vascostem