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Buerger's DiseaseNCT01302015

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

A study testing RNL-Vascostem® in people with Buerger's Disease, run by R-Bio at 2 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Buerger's Disease
What is being tested?
RNL-Vascostem®
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
2 sitesSouth Korea
Study dates
Dec 2007to Dec 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

2 sites in 1 country.

South Korea2 sites

  • Seoul St. Mary's Hospital

    Seoul

  • SMG-SNU Boramae Medical Center

    Seoul

Other trials in South Korea

About this study

Official title: Safety and Efficacy of Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Buerger's Disease

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.

Read the 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.

Being tested
RNL-Vascostem®
Medical subject headings
Thromboangiitis Obliterans

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RNL-Vascostem®Biological

    Also called Autologous adipose tissue derived mesenchymal stem cells

Study groups in NCT01302015
Study groupRoleWhat they receive
RNL-Vascostem®Experimentaldrug name and ingredients : RNL-Vascostem[Autologous adipose tissue derived mesenchymal stem cells] dosage : Intramuscular infusion, 5 x 10e6 cells/kg
Receives: Biological: RNL-Vascostem®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treadmill Walking Distance

    Improvement in TWD(Treadmill Walking Distance)

    Measured: 24 weeks

Secondary outcomes (9)

  1. VAS(Visual Analog Scale)

    Improvement in VAS(Visual Analog Scale) score

    Measured: 24 weeks

  2. Toe-Brachial Pressure Index, TBPI

    Improvement in TBPI score

    Measured: 24 weeks

  3. Transcutaneous oxygen pressure, TcPO2

    Improvement in TcPO2 score

    Measured: 24 weeks

  4. Arterial Brachial Pressure Index, ABPI

    Improvement in ABPI score

    Measured: 24 weeks

  5. Pain Free Walking Distance, PFWD

    Improvement in PFWD score

    Measured: 24 weeks

  6. Angiography

    Improvement on Angiography

    Measured: 24 weeks

  7. Laser Doppler

    Improvement on Laser Doppler

    Measured: 24 weeks

  8. dose and frequency in use of a analgesic medicine

    Changes in dose and frequency in use of a analgesic medicine

    Measured: 24 weeks

  9. Safety Evaluation

    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

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2011 (estimated)
  2. Study startDec 2007
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01302015
Sponsor's protocol ID
Vascostem
Status last verified
Jun 2019
First submitted
17 Feb 2011
Last updated
5 Jun 2019
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 22498564

Questions about this trial

What is this clinical trial studying?

A study testing RNL-Vascostem® in people with Buerger's Disease, run by R-Bio at 2 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treadmill Walking Distance (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01302015, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2019.

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