The translation of cell-based therapies: clinical landscape and manufacturing challenges

Thomas R.J. Heathman, Alvin W. Nienow, Mark J. McCall, Karen Coopman, Bo Kara, Christopher J. Hewitt*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review


Cell-based therapies have the potential to make a large contribution toward currently unmet patient need and thus effective manufacture of these products is essential. Many challenges must be overcome before this can become a reality and a better definition of the manufacturing requirements for cell-based products must be obtained. The aim of this study is to inform industry and academia of current cell-based therapy clinical development and to identify gaps in their manufacturing requirements. A total of 1342 active cell-based therapy clinical trials have been identified and characterized based on cell type, target indication and trial phase. Multiple technologies have been assessed for the manufacture of these cell types in order to facilitate product translation and future process development.

Original languageEnglish
Pages (from-to)49-64
Number of pages16
JournalRegenerative medicine
Issue number1
Early online date1 Apr 2015
Publication statusPublished - 2015

Bibliographical note

This work is licensed under a Creative Commons Attribution-NonCommercial 3.0 Unported License.

Funding: EPSRC


  • bioreactor
  • cell-based therapy
  • clinical trials
  • manufacture
  • MSC
  • regenerative medicine
  • stem cell
  • translation


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