Cell Persistence of Allogeneic Keratinocytes and Fibroblasts Applied in a Fibrin Matrix to Acute, Full Thickness Wounds.

HP802-247 is a living cell suspension of cultured allogeneic growth-arrested human male keratinocytes and fibroblasts (1:9 ratio), intended for spray application to chronic wounds. In this study, a small wound was created on the arms of 28 healthy female volunteers (3-mm punch), followed by a single application of HP802-247. At each subsequent week for 8 weeks, a punch excision of the wounds was performed on a cohort of three subjects. Excised specimens were analyzed for allogeneic fibroblast and keratinocyte DNA determined by Y-chromosome short-tandem repeats using PCR amplification followed by capillary electrophoresis, a method with estimated sensitivity of 1 male cell in a background of 8,000 female cells. A complete haplotype attributable to HP802-247 fibroblasts was detected in three of three samples at 1 week, with one partial and one complete fibroblast haplotype detected at 2 weeks, and one partial keratinocyte haplotype detected at 3 weeks postapplication. The findings indicate that HP802-247 can be expected to persist in an acute wound bed for up to 2 weeks postapplication.

Clinical efficacy evaluation of a novel barrier protection cream.

COR806.805 (Tetrix Cream) is a new barrier cream formulated using a unique patented technology. As a water-in-oil emulsion, COR806.805 has a water-resistant outer surface and water-soluble inner surface. Clinical studies have demonstrated the safety of COR806.805 in healthy adults with respect to sensitization, irritation, and effect on the healing of existing skin lesions. We report the results of trials undertaken to explore the substantivity and barrier protection properties of this new product when applied to clinically normal skin, as well as the beneficial effects when applied to inflamed skin, including skin affected by eczema. The results indicate that the cream establishes a barrier against common irritants, with persistence over 6 hours. The product appears effective and well-tolerated as a barrier and also may provide benefit in managing the itching and burning associated with contact dermatitis.

Clinical safety evaluation of a novel barrier protection cream.

Patients with contact dermatitis require both preventive and therapeutic interventions to minimize their burden of disease. The ideal product would support resolution of inflamed skin without the use of glucocorticoids while protecting undamaged skin against further contact with irritants and antigens. COR806.805 (Tetrix Cream) is a novel barrier cream formulated for use on both lesional and nonlesional skin. Three clinical trials were conducted to evaluate the safety of this new product by studying sensitization, cumulative irritation, and effect on healing; a combined total of 265 participants completed the studies (210, 45, and 10, respectively), with no serious adverse events considered to be related to the product. Six mild adverse events were considered related or potentially related. As tested, COR806.805 is neither sensitizing nor irritating when applied to intact or lesional skin. Testing indicates that COR806.805 does not inhibit healing of allergic contact dermatitis lesions.