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

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ClinicalTrials.gov Identifier: NCT01302015
Recruitment Status : Completed
First Posted : February 23, 2011
Last Update Posted : March 26, 2014
Sponsor:
Information provided by (Responsible Party):
Biostar

Study Description
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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.

Condition or disease Intervention/treatment Phase
Buerger's Disease Biological: RNL-Vascostem® Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Buerger's Disease
Study Start Date : December 2007
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Autologous adipose tissue derived mesenchymal stem cells


Outcome Measures
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Primary Outcome Measures :
  1. Treadmill Walking Distance [ Time Frame: 24 weeks ]
    Improvement in TWD(Treadmill Walking Distance)


Secondary Outcome Measures :
  1. VAS(Visual Analog Scale) [ Time Frame: 24 weeks ]
    Improvement in VAS(Visual Analog Scale) score

  2. Toe-Brachial Pressure Index, TBPI [ Time Frame: 24 weeks ]
    Improvement in TBPI score

  3. Transcutaneous oxygen pressure, TcPO2 [ Time Frame: 24 weeks ]
    Improvement in TcPO2 score

  4. Arterial Brachial Pressure Index, ABPI [ Time Frame: 24 weeks ]
    Improvement in ABPI score

  5. Pain Free Walking Distance, PFWD [ Time Frame: 24 weeks ]
    Improvement in PFWD score

  6. Angiography [ Time Frame: 24 weeks ]
    Improvement on Angiography

  7. Laser Doppler [ Time Frame: 24 weeks ]
    Improvement on Laser Doppler

  8. dose and frequency in use of a analgesic medicine [ Time Frame: 24 weeks ]
    Changes in dose and frequency in use of a analgesic medicine

  9. Safety Evaluation [ Time Frame: 24 weeks ]
    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


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01302015


Locations
Korea, Republic of
Seoul St. Mary's Hospital
Seoul, Korea, Republic of
SMG-SNU Boramae Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Biostar
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
More Information
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Responsible Party: Biostar
ClinicalTrials.gov Identifier: NCT01302015     History of Changes
Other Study ID Numbers: Vascostem
First Posted: February 23, 2011    Key Record Dates
Last Update Posted: March 26, 2014
Last Verified: March 2014

Additional relevant MeSH terms:
Thromboangiitis Obliterans
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Vasculitis