NCT01302015

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

February 17, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 23, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

June 5, 2019

Status Verified

June 1, 2019

Enrollment Period

6 years

First QC Date

February 17, 2011

Last Update Submit

June 3, 2019

Conditions

Buerger's Disease

Outcome Measures

Primary Outcomes (1)

  • Treadmill Walking Distance

    Improvement in TWD(Treadmill Walking Distance)

    24 weeks

Secondary Outcomes (9)

  • VAS(Visual Analog Scale)

    24 weeks

  • Toe-Brachial Pressure Index, TBPI

    24 weeks

  • Transcutaneous oxygen pressure, TcPO2

    24 weeks

  • Arterial Brachial Pressure Index, ABPI

    24 weeks

  • Pain Free Walking Distance, PFWD

    24 weeks

  • +4 more secondary outcomes

Study Arms (1)

RNL-Vascostem®

EXPERIMENTAL

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

Biological: RNL-Vascostem®

Interventions

RNL-Vascostem®BIOLOGICAL
Also known as: Autologous adipose tissue derived mesenchymal stem cells
RNL-Vascostem®

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • Patients with acute myocardial infarction, angina pectoris.
  • Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Seoul St. Mary's Hospital

Seoul, South Korea

Location

SMG-SNU Boramae Medical Center

Seoul, South Korea

Location

Related 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. 2012;76(7):1750-60. doi: 10.1253/circj.cj-11-1135. Epub 2012 Apr 12.

    PMID: 22498564RESULT

MeSH Terms

Conditions

Thromboangiitis Obliterans

Condition Hierarchy (Ancestors)

Arterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesVasculitis

Study Officials

  • Sang-Hong Baek, M.D.&Ph.D.

    Seoul St. Mary's Hospital

    PRINCIPAL INVESTIGATOR

  • Eui Cheol Jeong, M.D.

    SMG-SNU Boramae Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2011

First Posted

February 23, 2011

Study Start

December 1, 2007

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

June 5, 2019

Record last verified: 2019-06

Locations

KR(2)