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

This study has been completed.
Sponsor:
Collaborator:
Uppsala University
Information provided by:
Innoventus Project AB
ClinicalTrials.gov Identifier:
NCT00689143
First received: May 29, 2008
Last updated: October 28, 2008
Last verified: October 2008
  Purpose

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.


Condition Intervention Phase
Periodontitis
Drug: sargramostim
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Innoventus Project AB:

Primary Outcome Measures:
  • To establish the safety profile of three escalating doses of Leukine when given as single intragingival injections on separate days [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To perform a pharmacokinetic evaluation after administration of three escalating doses of Leukine into the gingival tissue as single doses on separate days [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: August 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: sargramostim
    Other Names:
    • GM-CSF
    • Leukine
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.

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00689143

Locations
Sweden
Dept of Oral & Maxillofacial Surgery
Uppsala, Sweden, SE-751 85
Sponsors and Collaborators
Innoventus Project AB
Uppsala University
Investigators
Principal Investigator: Jan Hirsch, Prof. Dept of Oral & Maxillofacial Surgery, Uppsala University Hospital, Sweden
  More Information

No publications provided

Responsible Party: Innoventus Project AB
ClinicalTrials.gov Identifier: NCT00689143     History of Changes
Other Study ID Numbers: IPPIS-0604
Study First Received: May 29, 2008
Last Updated: October 28, 2008
Health Authority: Sweden: Medical Products Agency

Additional relevant MeSH terms:
Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on September 16, 2014