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

Information source: Innoventus Project AB
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Periodontitis

Intervention: sargramostim (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Innoventus Project AB

Official(s) and/or principal investigator(s):
Jan Hirsch, Prof., Principal Investigator, Affiliation: Dept of Oral & Maxillofacial Surgery, Uppsala University Hospital, Sweden


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.

Clinical Details

Official title: A Phase I, Open-Label, Single Center, Safety/Tolerability and Pharmacokinetic Study of Leukine® Administrated in the Gingiva as Three Single Doses on Separate Days

Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: To establish the safety profile of three escalating doses of Leukine when given as single intragingival injections on separate days

Secondary outcome: To perform a pharmacokinetic evaluation after administration of three escalating doses of Leukine into the gingival tissue as single doses on separate days

Detailed 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.


Minimum age: 20 Years. Maximum age: 40 Years. Gender(s): Both.


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


- Lack of suitability for participation in the trial, for any reason, as judged by the


Locations and Contacts

Dept of Oral & Maxillofacial Surgery, Uppsala SE-751 85, Sweden
Additional Information

Starting date: August 2008
Last updated: October 28, 2008

Page last updated: August 23, 2015

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