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NCT03865394: 1ABC

Treatment of Chronic Wounds in Diabetic Foot Syndrome With Allogeneic Adipose Derived Mesenchymal Stem Cells

Completed Phase 1, PHASE2 Last updated 14 October 2021
What this trial tests

Phase 1, PHASE2 trial testing Application of allogeneic ADSC stem cells in fibrin gel in Diabetic Foot Ulcer in 46 participants. Completed in 30 September 2021.

Timeline
1 July 2019
Primary endpoint
31 March 2021
30 September 2021

Quick facts

Lead sponsorMedical University of Warsaw
PhasePhase 1, PHASE2
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment46
Start date1 July 2019
Primary completion31 March 2021
Estimated completion30 September 2021
Sites1 location across Poland

Drugs / interventions tested

Conditions studied

Sponsor

Medical University of Warsaw

Who can join

18 and older, any sex, with Diabetic Foot Ulcer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of this study is to investigate efficiency of applying of adipose-derived mesenchymal stem cells (ADSC) in treatment of chronic wounds in diabetic foot syndrome.

Publications & conference data

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

  1. Diabetic Wound-Healing Science.
    Burgess JL, Wyant WA, Abdo Abujamra B, Kirsner RS, et al · · 2021 · cited 447× · PMID 34684109 · DOI 10.3390/medicina57101072
  2. Fat Therapeutics: The Clinical Capacity of Adipose-Derived Stem Cells and Exosomes for Human Disease and Tissue Regeneration.
    Shukla L, Yuan Y, Shayan R, Greening DW, et al · · 2020 · cited 129× · PMID 32194404 · DOI 10.3389/fphar.2020.00158
  3. Adipose Tissue-Derived Mesenchymal Stem/Stromal Cells and Their Contribution to Angiogenic Processes in Tissue Regeneration.
    Krawczenko A, Klimczak A. · · 2022 · cited 64× · PMID 35269568 · DOI 10.3390/ijms23052425
  4. Adipose-derived stromal cells for nonhealing wounds: Emerging opportunities and challenges.
    Deptuła M, Brzezicka A, Skoniecka A, Zieliński J, et al · · 2021 · cited 38× · PMID 33522005 · DOI 10.1002/med.21789
  5. Innovative Functional Biomaterials as Therapeutic Wound Dressings for Chronic Diabetic Foot Ulcers.
    Da Silva J, Leal EC, Carvalho E, Silva EA. · · 2023 · cited 27× · PMID 37373045 · DOI 10.3390/ijms24129900
  6. Scaffold-based delivery of mesenchymal stromal cells to diabetic wounds.
    Du S, Zeugolis DI, O'Brien T. · · 2022 · cited 27× · PMID 35987712 · DOI 10.1186/s13287-022-03115-4
  7. Adipose-Derived Stromal Cells for Chronic Wounds: Scientific Evidence and Roadmap Toward Clinical Practice.
    Brembilla NC, Vuagnat H, Boehncke WH, Krause KH, et al · · 2023 · cited 20× · PMID 36571216 · DOI 10.1093/stcltm/szac081
  8. Sources, Characteristics, and Therapeutic Applications of Mesenchymal Cells in Tissue Engineering.
    Gonzalez-Vilchis RA, Piedra-Ramirez A, Patiño-Morales CC, Sanchez-Gomez C, et al · · 2022 · cited 19× · PMID 35092596 · DOI 10.1007/s13770-021-00417-1

Verify or expand the search:

Other recruiting trials for Diabetic Foot Ulcer

Currently open trials in the same condition.

Other Medical University of Warsaw trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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