Assessment of Long-term Outcomes of Soft-Tissue Augmentation by Injecting Fibroblasts Suspended in Hyaluronic Acid Filler.

Abstract

Importance: In previous studies, this group has reported that cultured human fibroblasts suspended in hyaluronic acid (HA) filler might have potential use as a long-lasting injectable soft-tissue filler. However, the data were insufficient to determine the long-term outcomes.

Objective: To evaluate the long-term outcomes of cultured human fibroblasts suspended in HA filler used for soft-tissue augmentation.

Design, setting, and participants: A long-term case series study was performed. Between January 2010 and December 2013, a total of 38 patients were treated with fibroblast-HA filler mixture to augment nasal dorsa, nasolabial folds, and cheek depressions. Of these 38 patients, patients with follow-up period of greater than 3 years were included in this study. A total of 22 patients met the inclusion criteria.

Main outcomes and measures: Subjective assessment was performed to evaluate degree and time of resorption, improvement, satisfaction, softness of injection sites, and willingness to recommend this treatment to others. Objective assessment was carried out with patients' photographs. Safety and tolerability were also evaluated for this treatment.

Results: Of the 22 patients included in this study, 19 were women; mean (SD) patient age was 43 (15) years. All 22 patients experienced improvement following the treatment. Twenty (91%) patients were satisfied with the treatment. Nineteen patients (86%) considered that the injection site was as soft as it was before treatment. Patients' mean (SD) grading of improvement, satisfaction, and softness were 4.50 (0.51) (95% CI, 4.27-4.73), 4.14 (0.71) (95% CI, 3.82-4.45), and 4.82 (0.50) (95% CI, 4.59-5.00) at the last visit, respectively. Objective assessment demonstrated postoperative improvement in all patients: a rating of "much improved" was given to 7 patients (32%) by investigator 1; 8 patients (36%) by investigator 2; and 12 patients (55%) the injecting physician. This treatment was well tolerated; no adverse event was recorded for any patient.

Conclusions and relevance: Injection of cultured human fibroblasts suspended in HA filler might be successful for long-term soft-tissue augmentation. To our knowledge, this study represents the longest follow-up study of soft-tissue augmentation with a fibroblast-HA filler mixture to date.

Level of evidence: 4.