Standard operating procedure for the good manufacturing practice-compliant production of human bone marrow mesenchymal stem cells

Livia Roseti, Marta Serra, Alessandra Bassi

Research output: Contribution to journalArticle

Abstract

According to the European Regulation (EC 1394/2007), Mesenchymal Stem Cells expanded in culture for clinical use are considered as Advanced Therapy Medicinal Products. As a consequence, they must be produced in compliance with Good Manufacturing Practice in order to ensure safety, reproducibility, and efficacy. Here, we report a Standard Operating Procedure describing the Good Manufacturing Practicecompliant production of Bone Marrow-derived Mesenchymal Stem Cells suitable for autologous implantation in humans. This procedure can be considered as a template for the development of investigational medicinal Mesenchymal Stem Cells-based product protocols to be enclosed in the dossier required for a clinical trial approval. Possible clinical applications concern local uses in the regeneration of bone tissue in nonunion fractures or in orthopedic and maxillofacial diseases characterized by a bone loss.

Original languageEnglish
Pages (from-to)171-186
Number of pages16
JournalMethods in molecular biology (Clifton, N.J.)
Volume1283
DOIs
Publication statusPublished - 2015

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Keywords

  • Advanced therapy medicinal products
  • Bone marrow
  • Bone regeneration
  • Good manufacturing practice
  • Mesenchymal stem cells
  • Quality control

ASJC Scopus subject areas

  • Molecular Biology
  • Genetics
  • Medicine(all)

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