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NCT03865394: 1ABC
Treatment of Chronic Wounds in Diabetic Foot Syndrome With Allogeneic Adipose Derived Mesenchymal Stem Cells
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.
31 March 2021
Quick facts
| Lead sponsor | Medical University of Warsaw |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 46 |
| Start date | 1 July 2019 |
| Primary completion | 31 March 2021 |
| Estimated completion | 30 September 2021 |
| Sites | 1 location across Poland |
Drugs / interventions tested
- Application of allogeneic ADSC stem cells in fibrin gel — full drug profile →
- Standard care in diabetic foot ulcer
Conditions studied
- Diabetic Foot Ulcer — all drugs for Diabetic Foot Ulcer →
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):
-
Diabetic Wound-Healing Science.
Burgess JL, Wyant WA, Abdo Abujamra B, Kirsner RS, et al · · 2021 · cited 447× · PMID 34684109 · DOI 10.3390/medicina57101072 -
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 -
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 -
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT03865394
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Diabetic Foot Ulcer
Currently open trials in the same condition.
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- NCT07396376 — Evaluation of ELU42 Topical Spray for the Treatment of Diabetic Foot Ulcers · Phase 1, PHASE2 · recruiting
- NCT07291817 — Intermittent Negative Pressure for Patients With Diabetic Foot Ulcers (INPRESS) Study · NA · recruiting
- NCT07209358 — EDX110 Randomized Control Trial for Treatment of DFUs · NA · recruiting
- NCT06938685 — Evaluating the Efficacy NeoThelium FT in the Treatment of Diabetic Foot Ulcers · NA · recruiting
Other Medical University of Warsaw trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03865394 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Medical University of Warsaw
- Last refreshed: 14 October 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03865394.
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