Safety and feasibility of autologous adipose-derived stromal vascular fraction in the treatment of keloids: a phase one randomized controlled pilot trial

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dc.contributor.authorMbiine, Ronald
dc.contributor.authorKayiira, Anthony
dc.contributor.authorWayengera, Misaki
dc.contributor.authorGuyton, Munabi Ian
dc.contributor.authorKiwanuka, Noah
dc.contributor.authorAlenyo, Rose
dc.contributor.authorWamala Kalanzi, Edris
dc.contributor.authorMuwonge, Haruna
dc.contributor.authorNakanwagi, Cephas
dc.contributor.authorJoloba, Moses
dc.contributor.authorGalukande, Moses
dc.date.accessioned2023-09-05T18:16:38Z
dc.date.available2023-09-05T18:16:38Z
dc.date.issued2023
dc.description.abstractAutologous adipose-derived stromal vascular fraction (SVF) has been described to have therapeutic benefits in the treatment of keloids. However, most of the evidence on its efficacy is based on observational studies the majority of which are conducted in high-income countries and yet the highest burden of keloids is in low- and middle-income countries (LMICs). Objectives: We set out to determine the safety and feasibility of using autologous adipose derived stromal vascular fraction in the treatment of keloids in LMICs. Methods: In this phase II randomized controlled pilot clinical trial conducted in the Plastic Surgery Unit of Kirruddu National Referral Hospital in Kampala Uganda, 8 patients were assigned a 1:1 ratio to either SVF or triamcinolone acetonide (TAC) arms. In the SVF arm, a median (Inter quartile range) amount of stromal cell infiltration of 2.7×106 (11×106) was administered, while the controls received 10 mg/ml TAC at a ratio of 1:1 TAC to keloid volume. Primary endpoints were adverse event 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: The participants’ 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 ulceration in a single patient in the TAC arm, which was a grade II adverse event, was reported. Recruitment feasibility of 80% and interventional feasibility with 100% completion were reported. Conclusion: Based on our findings, an autologous adipose-derived stromal vascular fraction is feasible and safe for the treatment of keloids in LMICs.en_US
dc.identifier.citationMbiine, R., Kayiira, A., Wayengera, M., Guyton, M. I., Kiwanuka, N., Alenyo, R., ... & Galukande, M. (2023). Safety and feasibility of autologous adipose-derived stromal vascular fraction in the treatment of keloids: a phase one randomized controlled pilot trial. American Journal of Stem Cells, 12(2), 23.en_US
dc.identifier.issn2160-4150
dc.identifier.urihttps://nru.uncst.go.ug/handle/123456789/9177
dc.language.isoenen_US
dc.publisherAmerican Journal of Stem Cellsen_US
dc.subjectStromal vascular fractionen_US
dc.subjectAdipose stem cellsen_US
dc.subjectKeloidsen_US
dc.subjectScarsen_US
dc.subjectLow middle-income countriesen_US
dc.titleSafety and feasibility of autologous adipose-derived stromal vascular fraction in the treatment of keloids: a phase one randomized controlled pilot trialen_US
dc.typeArticleen_US
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