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

NCT02071199 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2016-11-29

No results posted yet for this study

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

Conditions

  • Gingivitis

Interventions

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

Sponsors & Collaborators

  • Noveome Biotherapeutics, formerly Stemnion

    lead INDUSTRY

Principal Investigators

  • David L Steed, MD · Noveome Biotherapeutics, formerly Stemnion

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2015-10-31
Completion
2015-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02071199 on ClinicalTrials.gov