Study Name:  Intraamniotic Administrations of ER004 in Male Subjects With X-linked Hypohidrotic Ectodermal Dysplasia (EDELIFE)

Principal Investigator: Holm Schneider, M.D., University Erlangen-Nürnberg,

Collaborating Investigator(s) Sought: No

Patients Sought:  Pregnant women carrying a male fetus affected by XLHED (confirmed by sonographic diagnosis of a significantly reduced number of fetal tooth germs or by genetic diagnosis of an EDA mutation in the fetus). Enrolment requires getting in touch with the study site prior to gestational week 26.

Additional Information:  This is a prospective, open-label, genotype-match controlled, multicenter clinical trial to investigate the efficacy and safety of intraamniotic administration of ER004, an ectodysplasin A replacement protein, as a prenatal treatment for male subjects with XLHED.

Funding:  EspeRare Foundation, German Federal Ministry of Education and Research, and Pierre Fabre