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Randomized Controlled Trial
. 2023 Apr 24;13(1):6616.
doi: 10.1038/s41598-023-33786-9.

A pilot study comparing the efficacy of autologous cultured fibroblast injections with hyaluronic acid fillers for treating nasolabial folds

Rungsima Wanitphakdeedecha  1 , Janice Natasha C Ng  2 , Phumithep Phumariyapong  2 , Ya-Nin Nokdhes  2 , Poramin Patthamalai  2 , Ploypailin Tantrapornpong  2 , Panittra Suphatsathienkul  2 , Chalermkwan Apinuntham  2 , Chadakan Yan  2 , Yanisorn Nanchaipruek  2 , Panwadee Thongjaroensirikul  2 , Pitchaya Maneeprasopchoke  2 , Thanya Techapichetvanich  2 , Sasima Eimpunth  2 , Woraphong Manuskiatti  2 , Saowalak Thanachaipiwat  3 , Uraiwan Panich  3
Affiliations
Randomized Controlled Trial

A pilot study comparing the efficacy of autologous cultured fibroblast injections with hyaluronic acid fillers for treating nasolabial folds

Rungsima Wanitphakdeedecha et al. Sci Rep. .

Abstract

Autologous cultured fibroblast injections for soft tissue augmentation are a potential alternative to other filler materials. No studies have compared autologous fibroblast injections and hyaluronic acid (HA) fillers for treating nasolabial folds (NLFs). To compare the efficacies and safeties of autologous cultured fibroblast injections and HA fillers for treating NLFs. This prospective, evaluator-blinded, pilot study enrolled 60 Thai female adult patients diagnosed with moderate to severe NLFs. They were randomized to receive either 3 treatments of autologous fibroblasts at 2-week intervals or 1 treatment with HA fillers. The primary outcome was the clinical improvement of the NLFs graded by 2 blinded dermatologists immediately after injection and at 1-, 3-, 6-, and 12-month follow-ups. Objective measurement of the NLF volume was evaluated. Patient self-assessment scores, pain scores, and adverse reactions were recorded. Of the 60 patients, 55 (91.7%) completed the study protocol. The NLF volumes improved significantly in the autologous fibroblast group at all follow-ups relative to baseline (P = 0.000, 0.004, 0.000, 0.000, and 0.003). The patients in the autologous fibroblast group rated more noticeable NLF improvements than those in the HA filler group (3-month follow-up, 58.41% vs. 54.67%; 6-month follow-up, 52.50% vs. 46%; 12-month follow-up, 44.55% vs. 31.33%). No serious adverse reactions were recorded. Autologous fibroblast injections are safe and effective for treating NLFs. These injections also promise sustained growth of living cells, possibly leading to a greater persistence than shown by other fillers.

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Conflict of interest statement

Financial competing interests. Saowalak Thanachaipiwat, Uraiwan Panich, and Rungsima Wanitphakdeedecha are the inventors of autologous fibroblast culture and preparation. Petty patent application has been filed by Institute for Technology and Innovation Management (INT), Mahidol University at the Department of Intellectual Property since March 10, 2022 with application number of 2203000625. The status of the application is now under reviewed. All other authors declare that they have no conflicts of interest related to any aspect of this research.

Figures

Figure 1
Figure 1
Subjective assessments by blinded dermatologists of the HA and autologous fibroblast groups at all follow-ups.
Figure 2
Figure 2
Patient self-assessments of the improvement to NLFs at all follow-ups.
Figure 3
Figure 3
Clinical photographs of an HA filler group participant at (A) baseline, (B) immediately after injection, (C) the 1-month follow-up, (D) the 3-month follow-up, (E) the 6-month follow-up, and (F) the 12-month follow-up.
Figure 4
Figure 4
Clinical photographs of an autologous fibroblast group participant at (A) baseline, (B) immediately after injection, (C) the 1-month follow-up, (D) the 3-month follow-up, (E) the 6-month follow-up, and (F) the 12-month follow-up.
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