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
Paweł Kubik,
Daniela Gallo,
Maria Laura Tanda,
Jerzy Jankau,
Raffaele Rauso,
Wojciech Gruszczyński,
Aleksandra Pawłowska,
Paweł Chrapczyński,
Maciej Malinowski,
Dariusz Grzanka,
Marta Smolińska,
Paulina Antosik,
Maria-Luiza Piesiaków,
Bartłomiej Łukasik,
Agnieszka Pawłowska-Kubik,
Giorgio Stabile,
Stefania Guida,
Łukasz Kodłubański,
Tom Decates,
Nicola Zerbinati
Affiliations
Paweł Kubik
K-LAB Badania i Rozwój, 81-312 Gdynia, Poland
Daniela Gallo
Endocrine Unit, Department of Medicine and Surgery, University of Insubria, ASST dei Sette Laghi, 21100 Varese, Italy
Maria Laura Tanda
Endocrine Unit, Department of Medicine and Surgery, University of Insubria, ASST dei Sette Laghi, 21100 Varese, Italy
Jerzy Jankau
Department of Plastic Surgery, Medical University of Gdansk, 80-210 Gdańsk, Poland
Raffaele Rauso
Maxillofacial Surgery Unit, University of Campania “Luigi Vanvitelli”, 80138 Naples, Italy
Wojciech Gruszczyński
K-LAB Badania i Rozwój, 81-312 Gdynia, Poland
Aleksandra Pawłowska
K-LAB Badania i Rozwój, 81-312 Gdynia, Poland
Paweł Chrapczyński
K-LAB Badania i Rozwój, 81-312 Gdynia, Poland
Maciej Malinowski
K-LAB Badania i Rozwój, 81-312 Gdynia, Poland
Dariusz Grzanka
Department of Clinical Pathomorphology, Nicolaus Copernicus University, 85-094 Bydgoszcz, Poland
Marta Smolińska
Department of Clinical Pathomorphology, Nicolaus Copernicus University, 85-094 Bydgoszcz, Poland
Paulina Antosik
Department of Clinical Pathomorphology, Nicolaus Copernicus University, 85-094 Bydgoszcz, Poland
Maria-Luiza Piesiaków
K-LAB Badania i Rozwój, 81-312 Gdynia, Poland
Bartłomiej Łukasik
Medical Department, Matex Lab Switzerland SA, 1228 Geneve, Switzerland
Agnieszka Pawłowska-Kubik
Division of History & Philosophy of Medical Sciences, Medical University of Gdansk, 80-210 Gdańsk, Poland
Giorgio Stabile
Department of Clinical Dermatology, Università Vita-Salute San Raffaele, 20132 Milan, Italy
Stefania Guida
Department of Clinical Dermatology, Università Vita-Salute San Raffaele, 20132 Milan, Italy
Łukasz Kodłubański
Department of Human Rights and Intellectual Property Law, University of Gdansk, 80-309 Gdansk, Poland
Tom Decates
Department of Dermatology, Erasmus Medical Center, 3000 Rotterdam, The Netherlands
Nicola Zerbinati
Dermatologic Unit, Department of Medicine and Surgery, University of Insubria, 21100 Varese, Italy
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.
