Cath Lab Digest

Healthpoint Ltd (Fort Worth, Tex) has enrolled the first of a planned 235-subject Phase II dose response study investigating an experimental, cell-based wound therapy, HP802-247, which is intended for the treatment of venous leg ulcers. HP802-247 is a topical spray containing living keratinocytes and fibroblasts. Twenty-eight investigators in 18 states are conducting the study.

The trial is the second of two planned-dose response trials, extending the dose range being tested and exploring two plausible dose frequencies. Enrollment into the trial is preceded by screening and run-in phases and is expected to continue through the middle of 2010. The first trial showed promising results over a four-fold range of cell concentrations administered weekly. The trial is evaluating the benefits and safety of enhancing wound healing by using metabolically active donor cells to support the patient’s own skin cells’ healing ability. HP802-247 utilizes allogeneic cells, which are living human cells derived from an individual donor that are subsequently grown in a tissue culture, and then applied to an unrelated patient. The wound therapy product consists of both keratinocytes and fibroblasts, the two major cell types found in human skin. The cells are sprayed onto the wound surface in a self-polymerizing protein mesh intended to help the cells adhere to the tissue.

For more information, visit www.healthpoint.com.