Dataset Information

The Impact of N-Acetylcysteine on Autologous Fat Graft: First-in-Human Pilot Study.

ABSTRACT:

Background

Our goal was to determine whether N-acetylcysteine (NAC) administered to the tumescent solution can reduce oxidative stress and increase autologous fat graft (AFG) viability.

Methods

The study included 15 women with a mean age of 31.8 years (range 23-39 years) who underwent breast asymmetry correction with AFG harvested from both thighs. One thigh was infiltrated with a standard tumescent fluid (control graft) and other with a NAC-enriched tumescent fluid (NAC-treated graft). Each participant had breast MRI imaging before and 6 months after the procedure. Also, adipose tissue samples from each graft were subjected to biochemical analysis, flow cytometric assay and qRT-PCR to determine the markers of oxidative stress, angiogenesis and adipogenesis.

Results

Concentration and activity of superoxide dismutase in the NAC-treated grafts turned out to be significantly higher than in the control grafts, in both fresh (p = 0.041 and p = 0.023, respectively) and frozen samples (p = 0.004 and p = 0.003, respectively). The level of nitric oxide in frozen samples from the control grafts was significantly higher than in the NAC-treated grafts (p = 0.009). iNOS was the only qRT-PCR target showing significant intergroup differences, with higher transcription levels observed in the control grafts (p = 0.027). Breast volumetric analysis demonstrated that the NAC-treated group had a 12.19% lower resorption rate than the control group, although it was found to be statistically insignificant (p = 0.149). No postoperative complications were observed during a 6-month follow-up.

Conclusions

Some results of this study are promising. Further studies on larger groups are needed to determine NAC impact on AFG.

Level of evidence iv

This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Trial registry name

The Impact of N-Acetylcysteine on Volumetric Retention of Autologous Fat Graft for Breast Asymmetry Correction.

Registration identification number

NCT03197103. URL FOR THE REGISTRY: https://clinicaltrials.gov/ct2/show/NCT03197103?term=acetylcysteine&rank=6.

SUBMITTER: Pietruski P

PROVIDER: S-EPMC8481185 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:Background: Many children and adults with Obsessive-Compulsive Disorder (OCD) fail to respond to first-line pharmacological and behavioral treatments. Glutamate dysfunction may contribute to the development of OCD. N-acetylcysteine (NAC), a glutamate modulating drug, has shown to be a promising agent in adults with OCD. Methods: We conducted a double-blind, placebo-controlled clinical trial from July 2012 to January 2017. Children ages 8 to 17 years with OCD were assigned to receive NAC (up to 2700 mg/day) or the matching placebo for a period of 12 weeks. Children were required to be on stable psychiatric treatment (both medication and therapy) but were not required to be treatment-refractory. The primary outcome was OCD symptom severity as measured by the Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS). We used linear mixed models to analyze the effect of NAC compared to placebo. Results: Due to poor recruitment and eventual expiration of the study medication, enrollment was stopped at 11 children out of a planned sample size of 40. Nonetheless, NAC was associated with significant reduction in CY-BOCS total score compared to placebo (Satterthwaite's test: t (37) = 2.36, p = 0.024) with effects separating from placebo beginning at week 8. Mean CY-BOCS total score decreased in the NAC group from 21.4 ± 4.65 at baseline to 14.4 ± 5.55 at week 12. In the placebo group, mean CY-BOCS total score remained unchanged (21.3 ± 4.65). In the NAC group, 1 out of 5 participants achieved >35% improvement in CY-BOCS total score, while none of the six patients in placebo group reached this improvement level. NAC and placebo were well tolerated. One mild adverse event was reported in each group. Conclusions: Our trial suggests that there may be some initial improvement in OCD symptom severity with NAC treatment. NAC was well tolerated in the study population. Future trials should employ multiple sites and have a larger study population to further confirm any benefits of NAC.