Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Buerger's Disease

Buerger's Disease Clinical Trial

Official title:

Safety and Efficacy of Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Buerger's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01302015
• Other study ID #: Vascostem
• Status: Completed
• Phase: N/A
• Start date: December 2007
• Est. completion date: December 2013

Study information

• Verified date: June 2019
• Source: R-Bio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Buerger's Disease
• Thromboangiitis Obliterans

Intervention

Biological:
• RNL-Vascostem®

Locations

Country	Name	City	State
Korea, Republic of	Seoul St. Mary's Hospital	Seoul
Korea, Republic of	SMG-SNU Boramae Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
R-Bio

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treadmill Walking Distance	Improvement in TWD(Treadmill Walking Distance)	24 weeks
Secondary	VAS(Visual Analog Scale)	Improvement in VAS(Visual Analog Scale) score	24 weeks
Secondary	Toe-Brachial Pressure Index, TBPI	Improvement in TBPI score	24 weeks
Secondary	Transcutaneous oxygen pressure, TcPO2	Improvement in TcPO2 score	24 weeks
Secondary	Arterial Brachial Pressure Index, ABPI	Improvement in ABPI score	24 weeks
Secondary	Pain Free Walking Distance, PFWD	Improvement in PFWD score	24 weeks
Secondary	Angiography	Improvement on Angiography	24 weeks
Secondary	Laser Doppler	Improvement on Laser Doppler	24 weeks
Secondary	dose and frequency in use of a analgesic medicine	Changes in dose and frequency in use of a analgesic medicine	24 weeks
Secondary	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