Clin Exp Otorhinolaryngol.  2018 Dec;11(4):281-287. 10.21053/ceo.2017.01634.

Efficacy and Safety of Autologous Stromal Vascular Fraction in the Treatment of Empty Nose Syndrome

Affiliations
  • 1Department of Otolaryngology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. jangyj@amc.seoul.kr
  • 2Prostemics Research Institute, Seoul, Korea.

Abstract


OBJECTIVES
Regenerative treatment using stem cells may serve as treatment option for empty nose syndrome (ENS), which is caused by the lack of turbinate tissue and deranged nervous system in the nasal cavity. We aimed to assess the efficacy and safety of the autologous stromal vascular fraction (SVF) in the treatment of ENS.
METHODS
In this prospective observational clinical study, we enrolled 10 ENS patients who volunteered to undergo treatment of ENS through the injection of autologous SVF. Data, including demographic data, pre- and postoperative Sino-Nasal Outcome Test-25 (SNOT-25) scores, overall patient satisfaction, and postoperative complications, were prospectively collected. Nasal secretion was assessed using the polyurethane foam absorption method, and the levels of biological markers were analyzed in both ENS group and control group using enzyme-linked immunosorbent assay. The SVF extracted from abdominal fat was diluted and injected into both inferior turbinates.
RESULTS
Among the 10 initial patients, one was excluded from the study. Subjective satisfaction was rated as "much improved" in two and "no change" in seven. Among the improved patients, the mean preinjection SNOT-25 score was 55.0 and the score at 6 months after injection was 19.5. However, the average SNOT-25 score of nine participants at 6 months after injection (mean±standard deviation, 62.4±35.8) did not differ significantly from the baseline SNOT-25 score (70.1±24.7, P>0.05, respectively). Among the various inflammatory markers assessed, the levels of interleukin (IL)-1β, IL-8, and calcitonin gene-related peptide were significantly higher in ENS patients. Compared with preinjection secretion level, the nasal secretions from SVF-treated patients showed decreased expressions of IL-1β and IL-8 after injection.
CONCLUSION
Although SVF treatment appears to decrease the inflammatory cytokine levels in the nasal mucosa, a single SVF injection was not effective in terms of symptom improvement and patient satisfaction. Further trials are needed to identify a more practical and useful regenerative treatment modality for patients with ENS.

Keyword

Empty Nose Syndrome; Stem Cells; Stromal Vascular Fraction; Sino-Nasal Outcome Test-25; Cytokines

MeSH Terms

Abdominal Fat
Absorption
Biomarkers
Calcitonin Gene-Related Peptide
Clinical Study
Cytokines
Enzyme-Linked Immunosorbent Assay
Humans
Interleukin-8
Interleukins
Methods
Nasal Cavity
Nasal Mucosa
Nervous System
Nose*
Patient Satisfaction
Polyurethanes
Postoperative Complications
Prospective Studies
Stem Cells
Turbinates
Biomarkers
Calcitonin Gene-Related Peptide
Cytokines
Interleukin-8
Interleukins
Polyurethanes

Figure

  • Fig. 1. Sino-Nasal Outcome Test-25 (SNOT-25) scores at different time periods after stromal vascular fraction (SVF) injection. The mean SNOT25 scores ranged from 0 to 125, wherein a higher score indicated greater empty nose syndrome severity. (A) The data of nine patients undergoing SVF injection are included, and the mean baseline SNOT-25 score was 70.1±24.7. The overall change was not consistent over time (P>0.05). The mean SNOT-25 score was 45.78±27.74 at 3 months after injection as compared to the baseline score. (B) The data of two improved patients are also included, who had a mean baseline SNOT-25 score of 55.0±20.0. The effect of SVF injection was evident after 2 weeks, and was maintained thereafter. a)P=0.009 vs. baseline.

  • Fig. 2. Concentration of biomarkers of the control group, empty nose syndrome (ENS) group, and after stromal vascular fraction (SVF) injection group. (A) Comparisons of interleukin (IL)-1β, (B) IL-8, (C) calcitonin gene-related peptide (CGRP), (D) lactoferrin (LTF) levels. The IL-1β, IL-8, and CGRP levels were significantly higher in the ENS group than in the control group. The levels of IL-1β and IL-8 were significantly decreased after SVF injection. The LTF level did not significantly differ between the ENS and control group. The levels of CGRP and LTF were not significantly decreased after SVF injection. a)P<0.01 vs. the control group. b)P=0.013 vs. ENS group. c)P=0.014 vs. ENS group.


Cited by  1 articles

A Case of Empty Nose Syndrome Developed After Septal Spur Removal
Chol Ho Shin, Yong Ju Jang
Korean J Otorhinolaryngol-Head Neck Surg. 2023;66(4):268-272.    doi: 10.3342/kjorl-hns.2021.00878.


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