A Phase III Study of FCX-007 (Genetically-Modified Autologous Human Dermal Fibroblasts) for Recessive Dystrophic Epidermolysis Bullosa (RDEB)

Recruitment status: On hold for recruitment

Purpose of research

This study will look at an experimental therapy called FCX-007. FCX-007 is a genetically modified (changed) version of your own cells. FCX-007 is designed to deliver a functioning version of the collagen VII protein that is missing in RDEB patients into the skin. The study is designed to see how well FCX-007 works for treating RDEB wounds and to look at its safety.

How much time will be involved?

Participation in this study will require you to visit the research center about 7 times over the course of 10 months with overnight stays required if the research center is not local to you. You will not have to pay for travel expenses. People that participate in the study will also be asked to participate in a separate long term follow-up study so that the study doctor can monitor your health for up to 15 years.

Basic eligibility criteria:

To participate in the study you need to have been clinically diagnosed with Recessive Dystrophic Epidermolysis Bullosa (RDEB) ≥ 2 years of age. 

You will not be able to participate in this study if you cannot travel to the research center, if you have an active infection with HIV, hepatitis B or hepatitis C, or if you are pregnant or breastfeeding.

Link in clinicaltrials.gov: https://clinicaltrials.gov/ct2/show/NCT02810951

Contact:

Dr. Kunju Joshi Sridhar 650-721-4902 kunju@stanford.edu

Dr. Isin Sinem Bagci 650-484-6878 isbagci@stanford.edu

Dr. M. Peter Marinkovich 650-498-5425 mpm@stanford.edu