The Stem Cell Podcast

Ep. 59: “Clinical Grade” Featuring Dr. Tilo Kunath

Dec 8, 2015
Dr. Tilo Kunath, a group leader at the MRC Centre for Regenerative Medicine, discusses his groundbreaking research on clinical-grade stem cells and their application in patient therapies. He explains the critical distinction between clinical-grade and research-grade cells and shares insights on the Gene Modification Protocol for producing compliant lines. Tilo also touches on the implications of genomic variation and emphasizes the importance of safety testing. Plus, don’t miss his amusing anecdote about SEM images that sparked laughter!
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INSIGHT

Clinical Grade Is A Regulatory Designation

  • Clinical-grade cells differ from research-grade mainly by legal documentation, traceability, and how they're derived rather than by biology.
  • Tilo Kunath emphasizes that regulators define clinical grade and it's largely a documentation and process requirement.
INSIGHT

Re-Derivation Converts Research Lines To GMP

  • 'Re-derivation' means subcloning and expanding a research line under GMP/traceable conditions to make it acceptable for clinical use.
  • This process avoids returning to the original embryo but yields a clinically documented lineage.
INSIGHT

UK Invested Early In Traceable ES Lines

  • A planned national collection of clinical-grade ES lines was created to enable future therapies without re-derivation hurdles.
  • The UK invested early to derive lines from blastocysts under traceable conditions to ease later clinical use.
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