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

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

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.
    


Study Type

Interventional


Primary Outcome

Treadmill Walking Distance

Secondary Outcome

 VAS(Visual Analog Scale)

Condition

Buerger's Disease

Intervention

RNL-Vascostem®

Study Arms / Comparison Groups

 RNL-Vascostem®
Description:  drug name and ingredients : RNL-Vascostem[Autologous adipose tissue derived mesenchymal stem cells] dosage : Intramuscular infusion, 5 x 10e6 cells/kg

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

15

Start Date

December 2007

Completion Date

December 2013

Primary Completion Date

December 2013

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
      

Gender

All

Ages

20 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Sang-Hong Baek, M.D.&Ph.D., , 

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

Administrative Informations


NCT ID

NCT01302015

Organization ID

Vascostem


Responsible Party

Sponsor

Study Sponsor

R-Bio


Study Sponsor

Sang-Hong Baek, M.D.&Ph.D., Principal Investigator, Seoul St. Mary's Hospital


Verification Date

June 2019