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

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Noveome Biotherapeutics, formerly Stemnion
• Treatments: Pharmaceutical Solutions

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.