Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Buerger's Disease - Full Text View

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	Procedure: Autologous Adipose Tissue derived MSCs Transplantation	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

Further study details as provided by RNL Bio Company 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

Estimated Enrollment:	18
Study Start Date:	December 2007
Estimated Study Completion Date:	March 2014
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Intervention Details:

Intramuscular infusion of Autologous Adipose Tissue derived MSCs. Dose: 5x10e6 cells/kg

Other Name: 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.

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01302015

Contacts

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

whitesh@catholic.ac.kr

Locations

Korea, Republic of
Seoul St. Mary's Hospital	Recruiting
Seoul, Korea, Republic of
Contact: Sang-Hong Baek, M.D.&Ph.D. whitesh@catholic.ac.kr

Sponsors and Collaborators

RNL Bio Company Ltd.

Investigators

Principal Investigator:

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

Seoul St. Mary's Hospital

More Information

No publications provided

Responsible Party:	RNL Bio Company Ltd.
ClinicalTrials.gov Identifier:	NCT01302015 History of Changes
Other Study ID Numbers:	RB-Vascostem
Study First Received:	February 17, 2011
Last Updated:	January 15, 2013
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 May 21, 2013