Stem cell and cellular therapy developments.
Recent discoveries on human and non-human stem cells have prompted the development of several studies aimed at the translation of laboratory evidences into novel clinical procedures collectively known as 'cellular therapy'. In this regard, a number of features specifically related to the clinical setting require stringent evaluation, including, but not limited to: ethical appropriateness; donor and recipient informed consent; autologous versus allogeneic use; media and devices for cell collection, processing, characterization, storage and distribution; donor and recipient adverse events registration and management; risk-to-benefit and cost analysis; outcome analysis; production sites accreditation and management; regulatory oversight. This article describes recent national and international developments related to the distribution of cells and tissues for clinical use. Moreover, an example is reported of the implementation of a cellular therapy production site compliant with good manufacturing practices (GMPs) in a large European University hospital.
Strong
Michael
M
Northwest Tissue Center, Puget Sound Blood Center, USA. dmichaelstrong@mac.com
Farrugia
Albert
A
Rebulla
Paolo
P
D000818:Animals; D064987:Cell- and Tissue-Based Therapy / Q000379:methods* / Q000639:trends*; D003661:Decision Support Techniques; D006757:Hospital Units / Q000191:economics / Q000331:legislation & jurisprudence / Q000592:standards; D006801:Humans; D007390:International Agencies / Q000191:economics / Q000331:legislation & jurisprudence; D012015:Reference Standards; D033581:Stem Cell Transplantation / Q000191:economics / Q000331:legislation & jurisprudence / Q000639:trends*; D013234:Stem Cells / Q000166:cytology*