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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2008-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Periodontitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

sargramostim

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

GM-CSF Leukine

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Innoventus Project AB

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jan Hirsch, Prof.

Role: PRINCIPAL_INVESTIGATOR

Dept of Oral & Maxillofacial Surgery, Uppsala University Hospital, Sweden

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dept of Oral & Maxillofacial Surgery

Uppsala, , Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IPPIS-0604

Identifier Type: -

Identifier Source: org_study_id