title: Italian ethical committee intervention in a case of embryo-fetal medicine.
abstract: Embryo-fetal experimentation is intuitively associated with a therapeutic intent, according to a consolidated line of thought on the international and national levels. We report on a researcher's request for Ethics Committee approval to perform intrauterine transplantation of stem cells via cordocentesis on a fetus diagnosed with dystrophic epidermolysis bullosa, using stem cells obtained from a sibling's umbilical cord blood. The Ethics Committee rejected the request because of deontological issues and clinical judgments about the potential good to be derived from the procedure. In particular, in this case there was no preclinical or animal research on the procedure, the risk factors for mother and fetus were unknown, there was no way to guarantee compliance with Italian laws regarding safety and quality of the donor cells, and there was lack of clear informed consent.
authors.affiliation: Dipartimento di Medicina Pubblica e della Sicurezza Sociale--Sezione di Medicina Legale. Università degli Studi di Napoli, Federico II. drncannovo@libero.it
authors.forename: Nunzia
authors.initials: N
authors.lastname: Cannovo
authors.forename: Paola
authors.initials: P
authors.lastname: Buccelli
authors.forename: Jane
authors.initials: J
authors.lastname: Bryce
mesh_terms: D002675:Child, Preschool; D036101:Cord Blood Stem Cell Transplantation / Q000941:ethics* / Q000331:legislation & jurisprudence; D016108:Epidermolysis Bullosa Dystrophica / Q000628:therapy; D028744:Ethics Committees, Research; D005260:Female; D006801:Humans; D007258:Informed Consent / Q000941:ethics* / Q000331:legislation & jurisprudence; D007558:Italy; D008297:Male; D011247:Pregnancy; D035781:Siblings