Phase III study of cell-based therapy for venous leg ulcers
- Tue, 9/11/12 - 11:37am
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Healthpoint Biotherapeutics (Fort Worth, TX) announced the initiation of a Phase lll clinical trial investigating the efficacy of HP802-247 for the treatment of venous leg ulcers. HP802-247 is an investigational allogeneic living cell bioformulation containing keratinocytes and fibroblasts. The study is designed to evaluate complete wound closure in subjects receiving HP802- 247 plus compression therapy compared to those receiving vehicle control plus compression therapy over the 12-week treatment period.
The North American study is a randomized, double-blind study involving subjects 18 years of age and older with venous leg ulcers of at least 6 weeks but not more than 24 months duration. The ulcers must be between 2 cm2 and 12 cm2 in area at presentation. Approximately 440 subjects will be enrolled across 45 investigational centers in the United States and Canada.
For more information, visit www.healthpointbio.com.