We propose to carry out clinical safety and efficacy studies on the arg-gly-asp-containing wound healing agent developed under our Phase I grant. This product has been shown to be effective in the improvement of healing of several in vivo wound healing models, and has been found to be non-toxic, non-mutagenic and nonimmunogenic by the same criteria. We therefore propose to test this compound's safety in limited human clinical trials. After establishing the safety of the human use of the product, we will begin small (18 patient) trials into the effectiveness of the use of the product in the treatment of severe burns, chronic ulcers caused by vascular insufficiency, and the wounds resulting from the surgical incision of skin cancers. We also propose to carry out experiments leading to the efficient scale up of the production of the materials.
