SCIENCE-BOOK 29.04.2025 - Flipbook - Page 6
FILLERS
Safety profile
Summary of the publication:
Evaluation of the safety of Neauvia Stimulate injectable
product in patients with autoimmune thyroid diseases
based on histopathological examinations and
retrospective analysis of medical records
Authors: Kubik P. et al. I Published on 26.05.2023
INTRODUCTION
The aim of this study was to assess the effect of the hyaluronic acid cross-linked
with polyethylene glycol containing micronized portions of calcium hydroxyapatite
(Neauvia Stimulate, 26 mg/ml, L-proline, glycine, 1% CaHA) on both the local tissues
and the systemic consequences, which are crucial from a long-term safety perspective
in patients suffering from Hashimoto’s disease.
Inflammatory infiltration was analyzed before the treatment and 5, 21, and 150 days
post-treatment.
A total of 15 Hashimoto’s thyroiditis patients participated, each patient received 2.0 ml of
Neauvia Stimulate.
RESULTS
Decrease in the overall inflammatory infiltration (graph 1).
Decrease of the presence of T-lymphocytes (antigen recognizing CD4 & CD8).
Decrease of the presence of B-lymphocytes (CD20).
No correlation was demonstrated in:
anti-TPO (anti-thyroid peroxidase) (graph 2a)
anti-TG (antithyroglobulin) antibodies (graph 2b).
Graph 1
Graph 2a
Graph 2b
KEY MESSAGES
A significant decrease in the overall local inflammatory infiltrate
after PEGylated HA-CaHA injection at day 21 compared to baseline.
No correlation was demonstrated in anti-TPO and anti-TG antibodies.
Proven safety amongst Hashimoto patients included in the study.
CONCLUSION
Clinical outcomes of this study, as well as already published data, showed no
granuloma’s, foreign body reactions, or other complications, confirming the clinical
high safety profile and the high biocompatibility of PEGylated HA fillers, next to
the long-lasting result. There are no substantive or registered contraindications
to the use of PEGylated hyaluronic acid fillers in patients with Hashimoto’s.
Immunomodulatory effect of PEG has a positive effect on the safety profile when
assessing both the immune effects of the PEG hyaluronic acid filler, as well as the
biostimulatory effect obtained by the calcium hydroxyapatite particles.
Reference: Kubik, P.; Gallo, D.; Tanda, M.L.; Jankau, J.; Rauso, R.; Gruszczyński, W.; Pawłowska, A.; Chrapczyński, P.; Malinowski, M.;
Grzanka, D.; Smolińska, M.; Antosik, P.; Piesiaków, M.-L.; Łukasik, B.; Pawłowska-Kubik, A.; Stabile, G.; Guida, S.; Kodłubański, Ł.; Decates,
T.; Zerbinati, N. Evaluation of the Safety of Neauvia Stimulate Injectable Product in Patients with Autoimmune Thyroid Diseases Based on
Histopathological Examinations and Retrospective Analysis of Medical Records. Gels 2023, 9, 440. https://doi.org/10.3390/gels9060440.
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