Stem cell and cellular therapy developments

Michael Strong, Albert Farrugia, Paolo Rebulla

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish
Pages (from-to)103-107
Number of pages5
JournalBiologicals
Volume37
Issue number2
DOIs
Publication statusPublished - Apr 2009

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Keywords

  • Cells
  • GMP
  • Tissue
  • Transplants

ASJC Scopus subject areas

  • Biotechnology
  • Applied Microbiology and Biotechnology
  • Bioengineering
  • Immunology and Microbiology(all)
  • Pharmacology

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