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NCT01302015

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

Completed NA Last updated 3 June 2019
What this trial tests

NA trial testing RNL-Vascostem® in Buerger's Disease in 15 participants. Completed in 1 December 2013.

Timeline
1 December 2007
Primary endpoint
1 December 2013
1 December 2013

Quick facts

Lead sponsorR-Bio
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment15
Start date1 December 2007
Primary completion1 December 2013
Estimated completion1 December 2013
Sites2 locations across South Korea

Drugs / interventions tested

Conditions studied

Sponsor

R-Bio — full company profile →

Who can join

Adults 20 to 80, any sex, with Buerger's Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Adipose-Derived Stem Cells for Tissue Engineering and Regenerative Medicine Applications.
    Dai R, Wang Z, Samanipour R, Koo KI, et al · · 2016 · cited 191× · PMID 27057174 · DOI 10.1155/2016/6737345
  2. Tissue Engineering and Regenerative Medicine: Achievements, Future, and Sustainability in Asia.
    Han F, Wang J, Ding L, Hu Y, et al · · 2020 · cited 153× · PMID 32266221 · DOI 10.3389/fbioe.2020.00083
  3. Therapeutic angiogenesis of adipose-derived stem cells for ischemic diseases.
    Zhao L, Johnson T, Liu D. · · 2017 · cited 137× · PMID 28583178 · DOI 10.1186/s13287-017-0578-2
  4. Mesenchymal stem cell-based therapy for non-healing wounds due to chronic limb-threatening ischemia: A review of preclinical and clinical studies.
    Huerta CT, Voza FA, Ortiz YY, Liu ZJ, et al · · 2023 · cited 36× · PMID 36818343 · DOI 10.3389/fcvm.2023.1113982
  5. Emerging roles of mesenchymal stem cell therapy in patients with critical limb ischemia.
    Shirbaghaee Z, Hassani M, Heidari Keshel S, Soleimani M. · · 2022 · cited 36× · PMID 36068595 · DOI 10.1186/s13287-022-03148-9
  6. Growth factors for angiogenesis in peripheral arterial disease.
    Gorenoi V, Brehm MU, Koch A, Hagen A. · · 2017 · cited 25× · PMID 28594443 · DOI 10.1002/14651858.cd011741.pub2
  7. A Prospective, Nonrandomized, no Placebo-Controlled, Phase I/II Clinical Trial Assessing the Safety and Efficacy of Intramuscular Injection of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells in Patients With Severe Buerger's Disease.
    Ra JC, Jeong EC, Kang SK, Lee SJ, et al · · 2017 · cited 16× · PMID 28713639 · DOI 10.3727/215517916x693069

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