A phase IIa open-label dose-escalation pilot study using allogeneic human dermal fibroblasts for nasolabial folds.

Background And Objective: The correction of soft tissue contour defects and dermal atrophy is a growing area driven by medical and aesthetic need. Deterioration of the skin's appearance occurs as a result of age and trauma, such as surgery, infections, and acne. Typically, imperfections are treated with volume-correcting fillers.

Integration and persistence of an investigational human living skin equivalent (ICX-SKN) in human surgical wounds.

Aim: To present the first human clinical data on an investigational living skin graft replacement that is being designed for application where tissue has been lost through surgery, disease or trauma.

Materials & Methods: The ICX-SKN skin graft replacement is composed of an autosynthesized human collagen-based extracellular matrix and human dermal fibroblasts. In a first study to examine integration and persistence, full-thickness excisional wounds were made in six healthy human female volunteers and the ICX-SKN skin graft replacement applied and dressed.

Vaccinia-expressed human papillomavirus 16 and 18 e6 and e7 as a therapeutic vaccination for vulval and vaginal intraepithelial neoplasia.

Purpose: Anogenital intraepithelial neoplasia is a chronic disorder associated with infection by high-risk human papillomavirus (HPV) types. It is frequently multifocal and recurrence after conventional treatment is high. Boosting HPV-specific cell-mediated immune responses may reduce progression to carcinoma and could lead to disease clearance.

Human therapeutic cocaine vaccine: safety and immunogenicity.

This randomized, double blind, placebo controlled, phase I clinical trial assessed the safety and immunogenicity of a therapeutic cocaine vaccine TA-CD in 34 former cocaine abusers: 8 at 13 microg active vaccine, 10 at 82 microg and 10 at 709 microg, with two additional subjects getting placebo in each cohort. All got intra-muscular injections at 0-2 months and were monitored for safety and antibody production for 3 months. Of the 34 subjects 27 completed the full course of three injections, of these, only 24 returned for the final scheduled visit at day 84.