Clinical trial NCT05072353 - References

Diabetic Foot Ulcer — Effectiveness of the Autologous Adipose Tissue Harvested With SEFFICARE Method for Treatment of DFU Minor Amputation

Citation(s)

•   Álvaro-Afonso FJ, Sanz-Corbalán I, Lázaro-Martínez JL, Kakagia D, Papanas N
  Adipose-Derived Mesenchymal Stem Cells in the Treatment of Diabetic Foot Ulcers: A Review of Preclinical and Clinical Studies. Angiology. 2020 Oct;71(9):853-863. doi: 10.1177/0003319720939467. Epub 2020 Jul 29. Review.
•   Arcidiacono JA, Blair JW, Benton KA
  US Food and Drug Administration international collaborations for cellular therapy product regulation. Stem Cell Res Ther. 2012 Sep 28;3(5):38. doi: 10.1186/scrt129. Review.
•   Armstrong DG, Boulton AJM, Bus SA
  Diabetic Foot Ulcers and Their Recurrence. N Engl J Med. 2017 Jun 15;376(24):2367-2375. doi: 10.1056/NEJMra1615439. Review.
•   Bernardini FP, Gennai A, Izzo L, Zambelli A, Repaci E, Baldelli I, Fraternali-Orcioni G, Hartstein ME, Santi PL, Quarto R
  Superficial Enhanced Fluid Fat Injection (SEFFI) to Correct Volume Defects and Skin Aging of the Face and Periocular Region. Aesthet Surg J. 2015 Jul;35(5):504-15. doi: 10.1093/asj/sjv001. Epub 2015 Apr 24.
•   Bernardini FP, Gennai A
  Fluid Fat Injection for Volume Restoration and Skin Regeneration of the Periocular Aesthetic Unit. JAMA Facial Plast Surg. 2016 Jan-Feb;18(1):68-70. doi: 10.1001/jamafacial.2015.1146.
•   Bourin P, Bunnell BA, Casteilla L, Dominici M, Katz AJ, March KL, Redl H, Rubin JP, Yoshimura K, Gimble JM
  Stromal cells from the adipose tissue-derived stromal vascular fraction and culture expanded adipose tissue-derived stromal/stem cells: a joint statement of the International Federation for Adipose Therapeutics and Science (IFATS) and the International Society for Cellular Therapy (ISCT). Cytotherapy. 2013 Jun;15(6):641-8. doi: 10.1016/j.jcyt.2013.02.006. Epub 2013 Apr 6.
•   Cárdenas-Camarena L
  Lipoaspiration and its complications: a safe operation. Plast Reconstr Surg. 2003 Oct;112(5):1435-41; discussion 1442-3.
•   Caruana G, Bertozzi N, Boschi E, Pio Grieco M, Grignaffini E, Raposio E
  Role of adipose-derived stem cells in chronic cutaneous wound healing. Ann Ital Chir. 2015 Jan-Feb;86(1):1-4.
•   Casarini L, Lazzaretti C, Paradiso E, Limoncella S, Riccetti L, Sperduti S, Melli B, Marcozzi S, Anzivino C, Sayers NS, Czapinski J, Brigante G, Potì F, La Marca A, De Pascali F, Reiter E, Falbo A, Daolio J, Villani MT, Lispi M, Orlando G, Klinger FG, Fanelli F, Rivero-Müller A, Hanyaloglu AC, Simoni M
  Membrane Estrogen Receptor (GPER) and Follicle-Stimulating Hormone Receptor (FSHR) Heteromeric Complexes Promote Human Ovarian Follicle Survival. iScience. 2020 Nov 18;23(12):101812. doi: 10.1016/j.isci.2020.101812. eCollection 2020 Dec 18.
•   Danielsson M, Halvardson J, Davies H, Torabi Moghadam B, Mattisson J, Rychlicka-Buniowska E, Jaszczynski J, Heintz J, Lannfelt L, Giedraitis V, Ingelsson M, Dumanski JP, Forsberg LA
  Longitudinal changes in the frequency of mosaic chromosome Y loss in peripheral blood cells of aging men varies profoundly between individuals. Eur J Hum Genet. 2020 Mar;28(3):349-357. doi: 10.1038/s41431-019-0533-z. Epub 2019 Oct 25.
•   Dominici M, Le Blanc K, Mueller I, Slaper-Cortenbach I, Marini F, Krause D, Deans R, Keating A, Prockop Dj, Horwitz E
  Minimal criteria for defining multipotent mesenchymal stromal cells. The International Society for Cellular Therapy position statement. Cytotherapy. 2006;8(4):315-7.
•   Feldman EL, Stevens MJ, Thomas PK, Brown MB, Canal N, Greene DA
  A practical two-step quantitative clinical and electrophysiological assessment for the diagnosis and staging of diabetic neuropathy. Diabetes Care. 1994 Nov;17(11):1281-9.
•   Fink T, Lund P, Pilgaard L, Rasmussen JG, Duroux M, Zachar V
  Instability of standard PCR reference genes in adipose-derived stem cells during propagation, differentiation and hypoxic exposure. BMC Mol Biol. 2008 Oct 31;9:98. doi: 10.1186/1471-2199-9-98.
•   Frykberg RG, Zgonis T, Armstrong DG, Driver VR, Giurini JM, Kravitz SR, Landsman AS, Lavery LA, Moore JC, Schuberth JM, Wukich DK, Andersen C, Vanore JV; American College of Foot and Ankle Surgeons
  Diabetic foot disorders. A clinical practice guideline (2006 revision). J Foot Ankle Surg. 2006 Sep-Oct;45(5 Suppl):S1-66.
•   Gadelkarim M, Abushouk AI, Ghanem E, Hamaad AM, Saad AM, Abdel-Daim MM
  Adipose-derived stem cells: Effectiveness and advances in delivery in diabetic wound healing. Biomed Pharmacother. 2018 Nov;107:625-633. doi: 10.1016/j.biopha.2018.08.013. Epub 2018 Aug 14. Review.
•   Gennai A, Zambelli A, Repaci E, Quarto R, Baldelli I, Fraternali G, Bernardini FP
  Skin Rejuvenation and Volume Enhancement with the Micro Superficial Enhanced Fluid Fat Injection (M-SEFFI) for Skin Aging of the Periocular and Perioral Regions. Aesthet Surg J. 2017 Jan;37(1):14-23. Epub 2016 May 30.
•   Gimble JM, Guilak F, Bunnell BA
  Clinical and preclinical translation of cell-based therapies using adipose tissue-derived cells. Stem Cell Res Ther. 2010 Jun 29;1(2):19. doi: 10.1186/scrt19. Review.
•   Gutowski KA; ASPS Fat Graft Task Force
  Current applications and safety of autologous fat grafts: a report of the ASPS fat graft task force. Plast Reconstr Surg. 2009 Jul;124(1):272-280. doi: 10.1097/PRS.0b013e3181a09506.
•   Hingorani A, LaMuraglia GM, Henke P, Meissner MH, Loretz L, Zinszer KM, Driver VR, Frykberg R, Carman TL, Marston W, Mills JL Sr, Murad MH
  The management of diabetic foot: A clinical practice guideline by the Society for Vascular Surgery in collaboration with the American Podiatric Medical Association and the Society for Vascular Medicine. J Vasc Surg. 2016 Feb;63(2 Suppl):3S-21S. doi: 10.1016/j.jvs.2015.10.003.
•   Lazarus GS, Cooper DM, Knighton DR, Margolis DJ, Pecoraro RE, Rodeheaver G, Robson MC
  Definitions and guidelines for assessment of wounds and evaluation of healing. Arch Dermatol. 1994 Apr;130(4):489-93. Review.
•   Lonardi R, Leone N, Gennai S, Trevisi Borsari G, Covic T, Silingardi R
  Autologous micro-fragmented adipose tissue for the treatment of diabetic foot minor amputations: a randomized controlled single-center clinical trial (MiFrAADiF). Stem Cell Res Ther. 2019 Jul 29;10(1):223. doi: 10.1186/s13287-019-1328-4.
•   Mills JL Sr, Conte MS, Armstrong DG, Pomposelli FB, Schanzer A, Sidawy AN, Andros G; Society for Vascular Surgery Lower Extremity Guidelines Committee
  The Society for Vascular Surgery Lower Extremity Threatened Limb Classification System: risk stratification based on wound, ischemia, and foot infection (WIfI). J Vasc Surg. 2014 Jan;59(1):220-34.e1-2. doi: 10.1016/j.jvs.2013.08.003. Epub 2013 Oct 12.
•   Monteiro-Soares M, Russell D, Boyko EJ, Jeffcoate W, Mills JL, Morbach S, Game F; International Working Group on the Diabetic Foot (IWGDF)
  Guidelines on the classification of diabetic foot ulcers (IWGDF 2019). Diabetes Metab Res Rev. 2020 Mar;36 Suppl 1:e3273. doi: 10.1002/dmrr.3273.
•   Prompers L, Huijberts M, Apelqvist J, Jude E, Piaggesi A, Bakker K, Edmonds M, Holstein P, Jirkovska A, Mauricio D, Ragnarson Tennvall G, Reike H, Spraul M, Uccioli L, Urbancic V, Van Acker K, van Baal J, van Merode F, Schaper N
  High prevalence of ischaemia, infection and serious comorbidity in patients with diabetic foot disease in Europe. Baseline results from the Eurodiale study. Diabetologia. 2007 Jan;50(1):18-25. Epub 2006 Nov 9.
•   Prompers L, Schaper N, Apelqvist J, Edmonds M, Jude E, Mauricio D, Uccioli L, Urbancic V, Bakker K, Holstein P, Jirkovska A, Piaggesi A, Ragnarson-Tennvall G, Reike H, Spraul M, Van Acker K, Van Baal J, Van Merode F, Ferreira I, Huijberts M
  Prediction of outcome in individuals with diabetic foot ulcers: focus on the differences between individuals with and without peripheral arterial disease. The EURODIALE Study. Diabetologia. 2008 May;51(5):747-55. doi: 10.1007/s00125-008-0940-0. Epub 2008 Feb 23.
•   Rossi M, Roda B, Zia S, Vigliotta I, Zannini C, Alviano F, Bonsi L, Zattoni A, Reschiglian P, Gennai A
  Characterization of the Tissue and Stromal Cell Components of Micro-Superficial Enhanced Fluid Fat Injection (Micro-SEFFI) for Facial Aging Treatment. Aesthet Surg J. 2020 May 16;40(6):679-690. doi: 10.1093/asj/sjy142.
•   Salgado AJ, Reis RL, Sousa NJ, Gimble JM
  Adipose tissue derived stem cells secretome: soluble factors and their roles in regenerative medicine. Curr Stem Cell Res Ther. 2010 Jun;5(2):103-10. Review.
•   Schaper NC, Van Netten JJ, Apelqvist J, Lipsky BA, Bakker K; International Working Group on the Diabetic Foot (IWGDF)
  Prevention and management of foot problems in diabetes: A Summary Guidance for Daily Practice 2015, based on the IWGDF guidance documents. Diabetes Res Clin Pract. 2017 Feb;124:84-92. doi: 10.1016/j.diabres.2016.12.007. Epub 2016 Dec 18. Review.
•   Sheehan P, Jones P, Giurini JM, Caselli A, Veves A
  Percent change in wound area of diabetic foot ulcers over a 4-week period is a robust predictor of complete healing in a 12-week prospective trial. Plast Reconstr Surg. 2006 Jun;117(7 Suppl):239S-244S.
•   Tesfaye S, Boulton AJ, Dyck PJ, Freeman R, Horowitz M, Kempler P, Lauria G, Malik RA, Spallone V, Vinik A, Bernardi L, Valensi P; Toronto Diabetic Neuropathy Expert Group
  Diabetic neuropathies: update on definitions, diagnostic criteria, estimation of severity, and treatments. Diabetes Care. 2010 Oct;33(10):2285-93. doi: 10.2337/dc10-1303. Review. Erratum in: Diabetes Care. 2010 Dec;33(12):2725.
•   Thorud JC, Jupiter DC, Lorenzana J, Nguyen TT, Shibuya N
  Reoperation and Reamputation After Transmetatarsal Amputation: A Systematic Review and Meta-Analysis. J Foot Ankle Surg. 2016 Sep-Oct;55(5):1007-12. doi: 10.1053/j.jfas.2016.05.011. Epub 2016 Jul 27. Review.
•   Uccioli L, Izzo V, Meloni M, Vainieri E, Ruotolo V, Giurato L
  Non-healing foot ulcers in diabetic patients: general and local interfering conditions and management options with advanced wound dressings. J Wound Care. 2015 Apr;24(4 Suppl):35-42. doi: 10.12968/jowc.2015.24.Sup4b.35. Review.
•   Vizoso FJ, Eiro N, Cid S, Schneider J, Perez-Fernandez R
  Mesenchymal Stem Cell Secretome: Toward Cell-Free Therapeutic Strategies in Regenerative Medicine. Int J Mol Sci. 2017 Aug 25;18(9). pii: E1852. doi: 10.3390/ijms18091852. Review.
•   Yoshimura K, Shigeura T, Matsumoto D, Sato T, Takaki Y, Aiba-Kojima E, Sato K, Inoue K, Nagase T, Koshima I, Gonda K
  Characterization of freshly isolated and cultured cells derived from the fatty and fluid portions of liposuction aspirates. J Cell Physiol. 2006 Jul;208(1):64-76.
•   Zhang P, Lu J, Jing Y, Tang S, Zhu D, Bi Y
  Global epidemiology of diabetic foot ulceration: a systematic review and meta-analysis (†). Ann Med. 2017 Mar;49(2):106-116. doi: 10.1080/07853890.2016.1231932. Epub 2016 Nov 3. Review.
•   Zuk PA, Zhu M, Ashjian P, De Ugarte DA, Huang JI, Mizuno H, Alfonso ZC, Fraser JK, Benhaim P, Hedrick MH
  Human adipose tissue is a source of multipotent stem cells. Mol Biol Cell. 2002 Dec;13(12):4279-95.

Autologous Adipose Tissue Harvested With Superficial Enhanced Fluid Fat Injection (SEFFICARE) Method for Treatment of Diabetic Foot Ulcer Undergoing Minor Amputation (SEFFIDiFA): Proposal of Basic Research and Prospective Observational Study

Details for clinical trial NCT05072353