Use of amnion‐derived cellular cytokine solution for the treatment of gingivitis: A 2‐week safety, dose‐ranging, proof‐of‐principle randomized trial

Autor: Daniel Nguyen, David Steed, Constantinos Floros, MaryAnn Cugini, Melissa Martins, Jacqueline R. Starr, Hatice Hasturk, Emre Tosun, Thomas E. Van Dyke, Danielle Stephens
Rok vydání: 2021
Předmět:
Zdroj: Journal of Periodontology
ISSN: 1943-3670
0022-3492
DOI: 10.1002/jper.20-0800
Popis: Background A 6‐week Phase I clinical trial was performed to primarily evaluate the safety and secondarily determine the preliminary efficacy of a novel biological solution, ST266, comprised of a mixture of cytokines, growth factors, nucleic acids, and lipids secreted by cultured amnion‐derived multipotent progenitor cells on gingival inflammation. Methods Fifty‐four adults with gingivitis/periodontitis were randomly assigned to 1X ST266 or diluted 0.3X ST266 or saline topically applied on facial/lingual gingiva (20 µL/tooth). Safety was assessed through oral soft/hard tissue exam, adverse events, and routine laboratory tests. Efficacy was assessed by modified gingival index (MGI), bleeding on probing, plaque index, probing depth (PD), and clinical attachment level (CAL). Assessments were performed on day 0, 8, 12, and 42. ST266 and saline applied daily starting at day 0 through day 12 except weekend days. Plasma was analyzed for safety and proinflammatory cytokines, interleukin (IL)‐1β, IL‐6, tumor necrosis factor‐alpha, and interferon gamma. Gingival crevicular fluid (GCF) was analyzed for the same cytokines. Subgingival plaque was primarily analyzed by checkerboard DNA‐DNA hybridization. Comparisons with saline were modeled through a generalized estimating equations method adjusting for baseline. Results No safety concern was found related to ST266. Statistically significant reduction in MGI was noted at day 42 by 1X ST266 compared with saline (P = 0.044). PD and CAL were reduced by both doses of ST266 at day 42 (P
Databáze: OpenAIRE
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