NCT02071199

Treatment of Human Gingivitis With Amnion-derived Cellular Cytokine Solution (ACCS)

Treatment of Human Gingivitis With Topical ACCS: a Two Week Safety Dose-ranging and Proof-of-principle Trial

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Noveome Biotherapeutics, formerly Stemnion · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety of oral topical application of Amnion-derived Cellular Cytokine Solution (ACCS) in subjects with gingivitis

Detailed description

This randomized blinded study will evaluate the use of ACCS in subjects with gingivitis. Two doses of ACCS will be used. It will be given topically intra-orally daily Monday through Friday for 2 weeks. In the first cohort, a low dose of ACCS or saline will be given by random chance. If there are no safety issues, cohort two will include a higher dose of ACCS randomized with saline. Pocket depth, plaque index, gingival index, and bleeding on probing will be assessed. To assess shifts in supragingival flora, a qualitative and quantitative microbial analysis will be performed for common oral bacteria. There will also be an analysis of inflammatory cytokines in crevicular fluid at the beginning and end of the study. Comparisons of adverse events and outcomes will be made between the subjects receiving low dose ACCS, high dose ACCS, and saline.

Conditions

• Gingivitis

Interventions

Type	Name	Description
DRUG	1X ACCS (Amnion-derived Cellular Cytokine Solution)	1X ACCS will be applied to the gingival margin daily 5 days per week for 2 weeks
DRUG	Normal saline	Saline will be applied to the gingival margin daily 5 days per week for 2 weeks
DRUG	0.3X ACCS	0.3X ACCS will be applied to the gingival margin daily 5 days per week for 2 weeks

Timeline

• Start date: 2014-03-01
• Primary completion: 2015-10-01
• Completion: 2015-12-01
• First posted: 2014-02-25
• Last updated: 2016-11-29

Locations

1 site across 1 country: United States