(1) Background: Cervical intraepithelial neoplasia (CIN) of long-term persistence or associated with individual treatment indications often requires highly invasive treatments. These are associated with risks of bleeding, infertility, and pregnancy complications. For low- and middle-income countries (LMICs), standard treatment procedures are difficult to implement and manage. We characterized the application of the highly energized gas “noninvasive physical plasma” (NIPP) for tissue devitalization and the treatment of CIN. (2) Methods: We report the establishment of a promising tissue devitalization procedure by NIPP application. The procedure was characterized at the in vitro, ex vivo and in vivo levels. We performed the first prospective, single-armed phase-IIb trial in 20 CIN1/2 patients (NCT03218436). (3) Results: NIPP-treated cervical cancer cells used as dysplastic in vitro model exhibited significant cell growth retardation due to DNA damage, cell cycle arrest and apoptosis. Ex vivo and in vivo tissue assessments showed a highly noninvasive and tissue-preserving treatment procedure which induces transmucosal tissue devitalization. Twenty participants were treated with NIPP and attended a 24-week follow-up. Treatment success was achieved in 19 (95%) participants without postinterventional complications other than mild to moderate discomfort during application. (4) Conclusions: The results from this study preliminarily suggest that NIPP could be used for an effective and tissue-preserving treatment for CIN without the disadvantages of standard treatments. However, randomized controlled trials must confirm the efficacy and noninferiority of NIPP compared to standard treatments.
%0 Journal Article
%1 cancers14081933
%A Marzi, Julia
%A Stope, Matthias B.
%A Henes, Melanie
%A Koch, André
%A Wenzel, Thomas
%A Holl, Myriam
%A Layland, Shannon L.
%A Neis, Felix
%A Bösmüller, Hans
%A Ruoff, Felix
%A Templin, Markus
%A Krämer, Bernhard
%A Staebler, Annette
%A Barz, Jakob
%A Carvajal Berrio, Daniel A.
%A Enderle, Markus
%A Loskill, Peter M.
%A Brucker, Sara Y.
%A Schenke-Layland, Katja
%A Weiss, Martin
%D 2022
%J Cancers
%K anette_staebler grk2543 hans_boesmueller journal julia_marzi katja_schenke-layland martin_weiss myriam_holl reviewed sara_brucker
%N 8
%R 10.3390/cancers14081933
%T Noninvasive Physical Plasma as Innovative and Tissue-Preserving Therapy for Women Positive for Cervical Intraepithelial Neoplasia
%U https://www.mdpi.com/2072-6694/14/8/1933
%V 14
%X (1) Background: Cervical intraepithelial neoplasia (CIN) of long-term persistence or associated with individual treatment indications often requires highly invasive treatments. These are associated with risks of bleeding, infertility, and pregnancy complications. For low- and middle-income countries (LMICs), standard treatment procedures are difficult to implement and manage. We characterized the application of the highly energized gas “noninvasive physical plasma” (NIPP) for tissue devitalization and the treatment of CIN. (2) Methods: We report the establishment of a promising tissue devitalization procedure by NIPP application. The procedure was characterized at the in vitro, ex vivo and in vivo levels. We performed the first prospective, single-armed phase-IIb trial in 20 CIN1/2 patients (NCT03218436). (3) Results: NIPP-treated cervical cancer cells used as dysplastic in vitro model exhibited significant cell growth retardation due to DNA damage, cell cycle arrest and apoptosis. Ex vivo and in vivo tissue assessments showed a highly noninvasive and tissue-preserving treatment procedure which induces transmucosal tissue devitalization. Twenty participants were treated with NIPP and attended a 24-week follow-up. Treatment success was achieved in 19 (95%) participants without postinterventional complications other than mild to moderate discomfort during application. (4) Conclusions: The results from this study preliminarily suggest that NIPP could be used for an effective and tissue-preserving treatment for CIN without the disadvantages of standard treatments. However, randomized controlled trials must confirm the efficacy and noninferiority of NIPP compared to standard treatments.
@article{cancers14081933,
abstract = {(1) Background: Cervical intraepithelial neoplasia (CIN) of long-term persistence or associated with individual treatment indications often requires highly invasive treatments. These are associated with risks of bleeding, infertility, and pregnancy complications. For low- and middle-income countries (LMICs), standard treatment procedures are difficult to implement and manage. We characterized the application of the highly energized gas “noninvasive physical plasma” (NIPP) for tissue devitalization and the treatment of CIN. (2) Methods: We report the establishment of a promising tissue devitalization procedure by NIPP application. The procedure was characterized at the in vitro, ex vivo and in vivo levels. We performed the first prospective, single-armed phase-IIb trial in 20 CIN1/2 patients (NCT03218436). (3) Results: NIPP-treated cervical cancer cells used as dysplastic in vitro model exhibited significant cell growth retardation due to DNA damage, cell cycle arrest and apoptosis. Ex vivo and in vivo tissue assessments showed a highly noninvasive and tissue-preserving treatment procedure which induces transmucosal tissue devitalization. Twenty participants were treated with NIPP and attended a 24-week follow-up. Treatment success was achieved in 19 (95%) participants without postinterventional complications other than mild to moderate discomfort during application. (4) Conclusions: The results from this study preliminarily suggest that NIPP could be used for an effective and tissue-preserving treatment for CIN without the disadvantages of standard treatments. However, randomized controlled trials must confirm the efficacy and noninferiority of NIPP compared to standard treatments.},
added-at = {2023-06-27T07:42:29.000+0200},
article-number = {1933},
author = {Marzi, Julia and Stope, Matthias B. and Henes, Melanie and Koch, André and Wenzel, Thomas and Holl, Myriam and Layland, Shannon L. and Neis, Felix and Bösmüller, Hans and Ruoff, Felix and Templin, Markus and Krämer, Bernhard and Staebler, Annette and Barz, Jakob and Carvajal Berrio, Daniel A. and Enderle, Markus and Loskill, Peter M. and Brucker, Sara Y. and Schenke-Layland, Katja and Weiss, Martin},
biburl = {https://puma.ub.uni-stuttgart.de/bibtex/2022fc5026a0ff9effedeb3ae2bce7843/ffischer},
doi = {10.3390/cancers14081933},
interhash = {c3a46add078f9ce412275c190e9740f6},
intrahash = {022fc5026a0ff9effedeb3ae2bce7843},
issn = {2072-6694},
journal = {Cancers},
keywords = {anette_staebler grk2543 hans_boesmueller journal julia_marzi katja_schenke-layland martin_weiss myriam_holl reviewed sara_brucker},
number = 8,
pubmedid = {35454839},
timestamp = {2023-08-10T10:14:20.000+0200},
title = {Noninvasive Physical Plasma as Innovative and Tissue-Preserving Therapy for Women Positive for Cervical Intraepithelial Neoplasia},
url = {https://www.mdpi.com/2072-6694/14/8/1933},
volume = 14,
year = 2022
}