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

Several human studies show positive signals, while research methods and sample sizes continue to develop.

• Level A · Stronger Clinical Evidence
• Level B · Emerging clinical evidence with positive signals
• Level C · Early human research exploring benefits
• Level D · Scientific groundwork from lab and animal studies
• Emerging · Emerging topic under active research

Abstract (original English)

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 2.7x10 6 (11x10 6 ) 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

Evidence level

Several human studies show positive signals, while research methods and sample sizes continue to develop.

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