A Safety/Tolerability and Pharmakokinetic Study of Sargramostim Administrated in the Gingiva
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.
|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|
- 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 ]
- 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 ]
|Study Start Date:||August 2008|
|Study Completion Date:||October 2008|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
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.
|Dept of Oral & Maxillofacial Surgery|
|Uppsala, Sweden, SE-751 85|
|Principal Investigator:||Jan Hirsch, Prof.||Dept of Oral & Maxillofacial Surgery, Uppsala University Hospital, Sweden|