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

Author:

Kubik Paweł1,Gallo Daniela2ORCID,Tanda Maria Laura2ORCID,Jankau Jerzy3,Rauso Raffaele4ORCID,Gruszczyński Wojciech1,Pawłowska Aleksandra1,Chrapczyński Paweł1,Malinowski Maciej1,Grzanka Dariusz5ORCID,Smolińska Marta5ORCID,Antosik Paulina5,Piesiaków Maria-Luiza1,Łukasik Bartłomiej6,Pawłowska-Kubik Agnieszka7ORCID,Stabile Giorgio89,Guida Stefania89,Kodłubański Łukasz10ORCID,Decates Tom11ORCID,Zerbinati Nicola12

Affiliation:

1. K-LAB Badania i Rozwój, 81-312 Gdynia, Poland

2. Endocrine Unit, Department of Medicine and Surgery, University of Insubria, ASST dei Sette Laghi, 21100 Varese, Italy

3. Department of Plastic Surgery, Medical University of Gdansk, 80-210 Gdańsk, Poland

4. Maxillofacial Surgery Unit, University of Campania “Luigi Vanvitelli”, 80138 Naples, Italy

5. Department of Clinical Pathomorphology, Nicolaus Copernicus University, 85-094 Bydgoszcz, Poland

6. Medical Department, Matex Lab Switzerland SA, 1228 Geneve, Switzerland

7. Division of History & Philosophy of Medical Sciences, Medical University of Gdansk, 80-210 Gdańsk, Poland

8. Department of Clinical Dermatology, Università Vita-Salute San Raffaele, 20132 Milan, Italy

9. Dermatology Clinic, IRCCS San Raffaele Scientific Institute, 20132 Milan, Italy

10. Department of Human Rights and Intellectual Property Law, University of Gdansk, 80-309 Gdansk, Poland

11. Department of Dermatology, Erasmus Medical Center, 3000 Rotterdam, The Netherlands

12. Dermatologic Unit, Department of Medicine and Surgery, University of Insubria, 21100 Varese, Italy

Abstract

The aim of this study was to test the effect of hyaluronic acid cross-linked with polyethylene glycol containing micronized portions of calcium hydroxyapatite (Neauvia Stimulate) on both local tissue and systemic consequences, which are crucial from the perspective of long-term safety, in patients suffering from Hashimoto’s disease. This most common autoimmune disease is a frequently mentioned contraindication to the use of fillers based on hyaluronic acid as well as biostimulants based on calcium hydroxyapatite. Broad-spectrum aspects of histopathology were analyzed to identify key features of inflammatory infiltration before the procedure and 5, 21, and 150 days after the procedure. A statistically significant effect on the reduction of the intensity of the inflammatory infiltration in the tissue in relation to the state before the procedure was demonstrated, combined with a reduction in the occurrence of both antigen-recognizing (CD4) and cytotoxic (CD8) T lymphocytes. With complete statistical certainty, it was demonstrated that the treatment with Neauvia Stimulate had no effect on the levels of these antibodies. All this corresponds with the risk analysis that showed no alarming symptoms during the time of observation. The choice of hyaluronic acid fillers cross-linked with polyethylene glycol should be considered justified and safe in the case of patients suffering from Hashimoto’s disease.

Publisher

MDPI AG

Subject

Polymers and Plastics,Organic Chemistry,Biomaterials,Bioengineering

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