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Safety and Feasibility of Autologous Adipose-derived Stromal Vascular Fraction in the Treatment of Keloids: a Phase One Randomised Controlled Pilot Trial

Article scientifique 2021 Anglais

Résumé

Abstract Autologous adipose-derived stromal vascular fraction (SVF) is described as a therapeutic alternative in keloid treatment. However, most conclusions are based on observational with the majority conducted in high-income countries and yet the highest-burden of keloids is in Low-and middle-income countries (LMICs). In order to explore the therapeutic benefits of SVF in keloids, the safety and feasibility of their use in LMICs need to be evaluated.Methods: In this phase 1 randomized controlled pilot clinical trial conducted in the Plastic Surgery Unit of Kirruddu National Referral Hospital Kampala, 8 patients were assigned 1:1 ratio into either SVF or Triamcinolone Acetonide (TAC) arms. In the SVF arm, a median (IQR) number of stromal cell infiltration of 2.7x106 (11x106) was administered while the controls received 10mg/ml TAC in a ratio of 1:1 TAC into keloid volume. Primary end-points were adverse events development based on the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 tool and Feasibility assessment based on ≥70% recruitment feasibility and ≥80% interventional feasibility rates. Results: Participant mean age was 27.9 (±6.5) years with a female predilection of 5(63%). Overall, no adverse events were reported in the SVF arm while an ulceration in a single patient in the TAC arm which was a grade II adverse event was reported. Recruitment feasibility of 80% as well as interventional feasibility with 100% completion were reported. Conclusion: Based on our findings, autologous adipose-derived stromal vascular fraction is feasible and safe for the treatment of keloids. Trial registration: ClinicalTrials.gov, NCT04553159. Registered 17th September 2020. Link: https://clinicaltrials.gov/ct2/show/NCT04553159

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Mbiine, R., Kayiira, A., Wayengera, M., Munabi, I., Kiwanuka, N., Alenyo, R., Kalanzi, E., Muwonge, H., Nakanwagi, C., Joloba, M., Galukande, M. (2021). Safety and Feasibility of Autologous Adipose-derived Stromal Vascular Fraction in the Treatment of Keloids: a Phase One Randomised Controlled Pilot Trial. https://doi.org/10.21203/rs.3.rs-940210/v1

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Auteur(s)

Ronald Mbiine Anthony Kayiira Misaki Wayengera Ian G. Munabi Noah Kiwanuka Rose Alenyo Edris Wamala Kalanzi Haruna Muwonge Cephas Nakanwagi Moses Joloba Moses Galukande

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