Clinical trial NCT02071199: Treatment of Human Gingivitis With Amnion-derived Cellular Cytokine Solution (ACCS)
Official title: Treatment of Human Gingivitis With Topical ACCS: a Two Week Safety Dose-ranging and Proof-of-principle Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gingivitis
Keywords: Gingivitis
Periodontitis
ACCS
Lead sponsor: Noveome Biotherapeutics, formerly Stemnion
Sponsor class: INDUSTRY
First posted: 2014-02-25
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* good general health
* ages 18-70 years
* minimum of 20 natural teeth
* modified gingival index score of 2.0 or greater and \>40 percent bleeding sites at initial presentation.

Exclusion Criteria:

* presence of orthodontic appliance
* soft or hard tissue tumor of the oral cavity
* carious lesion requiring immediate treatment
* participation in another clinical trial within 30 days
* pregnant or breast-feeding women
* women of child-bearing potential refusing to use an acceptable method of birth control
* antibiotic therapy within the last 30 days
* chronic use (\> 3 times/week) of non-steroidal anti-inflammatory medications (NSAID). Any use of steroids. Low dose (\<325 mg) aspirin is allowed.
* immune-compromised subjects
* subjects with liver or kidney dysfunction on blood tests as evidenced by a value equal to or greater than 2X the upper limit of normal.
* any medical history or any concomitant medication that might affect the assessment of the study treatment or periodontal tissues such as diabetes rheumatoid arthritis, Crohn's disease, use of nifedipine, phenytoin (Dilantin), anticoagulant medications (e.g. warfarin), ongoing cancer treatment either with radiation of chemotherapy.

Primary outcomes:
measure: Incidence of adverse/serious adverse events
timeFrame: End of two weeks of treatment and at two weeks follow-up visit
Secondary outcomes:
measure: Probing pocket depth
timeFrame: Bseline and after two weeks of treatment
measure: Modified gingival index
timeFrame: Baseline and after two weeks of treatment
measure: Bleeding on probing
timeFrame: Baseline and after two weeks of treatment
measure: Plaque index
timeFrame: Baseline and after two weeks of treatment
measure: Microbial analysis
timeFrame: Baseline and after two weeks of treatment
measure: Cytokine analysis
timeFrame: Baseline and after two weeks of therapy
Other outcomes:
Locations:
city: Boston
country: United States
facility: Forsyth Institute
state: Massachusetts
Study officials:
affiliation: Noveome Biotherapeutics, formerly Stemnion
name: David L Steed, MD
role: STUDY_DIRECTOR
References: