A Safety/Tolerability and Pharmakokinetic Study of Sargramostim Administrated in the Gingiva

Innoventus Project

Status and phase

Completed

Phase 1

Conditions

Periodontitis

Treatments

Drug: sargramostim

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00689143

IPPIS-0604

Details and patient eligibility

About

This exploratory study is the first study in a clinical program where the overall objective is to develop a novel pharmaceutical therapy comprising local administration of GM-CSF for the treatment of periodontitis. The project hypothesis is based on GM-CSF's antibacterial and putative bone regeneration properties. Periodontitis is the major cause of tooth loss in people over 35 years of age. An effective pharmacological treatment is today lacking and the actual therapy would represent a new treatment option for the large patient group suffering from the disease.

Full description

It is suggested that local administration of GM-CSF in the gingival tissue next to the periodontal destruction may reduce the infectious condition by an antibacterial effect via stimulation of neutrophil phagocytosis of bacteria, enhanced functional activities of monocytes and granulocytes, as well as stimulation of bone tissue recalcification.

Enrollment

10 patients

Sex

All

Ages

20 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy individuals (male or female) referred to Dept of Oral & Maxillofacial surgery to have a lower wisdom tooth surgically extracted
≥ 20 and ≤ 40 years of age
Analysis results of blood status within normal reference ranges
Ability to attend the scheduled visits for evaluation procedures
Women with child-bearing potential: use of an adequate method of contraception to avoid pregnancy throughout the study
Signed informed consent

Exclusion criteria

Any significant disease (acute or chronic) or any medication with concomitant oral manifestations that in the opinion of the investigator would interfere with safety evaluation of Leukine.
An active osseous infection or periodontal infection, any active mucosal lesions or a history of acute necrotizing ulcerative gingivitis.
Current use of anti-coagulant therapy or within 10 days from baseline
Current use of immunomodulating medication
Current use of corticosteroids (Amendment 1: topical use permitted).
Current use of lithium.
Use of tobacco products or nicotine replacement therapy
Alcohol or drug abuse
HIV or hepatitis infection
Pregnancy or lactation
Participation in another clinical study on medicinal products at the time of inclusion
Lack of suitability for participation in the trial, for any reason, as judged by the Investigator.