Stem cell and cellular therapy developments

作者：Strong Michael; Farrugia Albert; Rebulla Paolo^*

来源：Biologicals, 2009, 37(2): 103-107.

DOI：10.1016/j.biologicals.2009.01.003

• Tissue
• Cells
• GMP
• Transplants

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.

• 出版日期2009-4