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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
K-Stemcell Co Ltd
ClinicalTrials.gov Identifier:
NCT01302015
First received: February 17, 2011
Last updated: March 24, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Buerger's Disease
Biological: RNL-Vascostem®
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by K-Stemcell Co Ltd:

Primary Outcome Measures:
  • Treadmill Walking Distance [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Improvement in TWD(Treadmill Walking Distance)


Secondary Outcome Measures:
  • VAS(Visual Analog Scale) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Improvement in VAS(Visual Analog Scale) score

  • Toe-Brachial Pressure Index, TBPI [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Improvement in TBPI score

  • Transcutaneous oxygen pressure, TcPO2 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Improvement in TcPO2 score

  • Arterial Brachial Pressure Index, ABPI [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Improvement in ABPI score

  • Pain Free Walking Distance, PFWD [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Improvement in PFWD score

  • Angiography [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Improvement on Angiography

  • Laser Doppler [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Improvement on Laser Doppler

  • dose and frequency in use of a analgesic medicine [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Changes in dose and frequency in use of a analgesic medicine

  • Safety Evaluation [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    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


Enrollment: 15
Study Start Date: December 2007
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
K-Stemcell Co Ltd
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

No publications provided

Responsible Party: K-Stemcell Co Ltd
ClinicalTrials.gov Identifier: NCT01302015     History of Changes
Other Study ID Numbers: Vascostem
Study First Received: February 17, 2011
Last Updated: March 24, 2014
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 20, 2014