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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00689143
Recruitment Status : Completed
First Posted : June 3, 2008
Last Update Posted : October 29, 2008
Uppsala University
Information provided by:
Innoventus Project AB

Brief Summary:
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 or disease Intervention/treatment Phase
Periodontitis Drug: sargramostim Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2008
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: sargramostim
    Other Names:
    • GM-CSF
    • Leukine

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00689143

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

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Responsible Party: Innoventus Project AB Identifier: NCT00689143    
Other Study ID Numbers: IPPIS-0604
First Posted: June 3, 2008    Key Record Dates
Last Update Posted: October 29, 2008
Last Verified: October 2008
Additional relevant MeSH terms:
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Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Immunologic Factors
Physiological Effects of Drugs