Guidance

Donation of starting material for advanced cell-based therapies

SaBTO recommendations on the donation of starting material for cell-based advanced therapies.

Detail

The Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) has reviewed the donation of starting material for cell-based advanced therapies, in particular issues relating to donor selection and testing, and informed consent and traceability.

SaBTO considered:

  • the potential risks of infection or genetic abnormality being transmitted by the donor, and how those risks could be mitigated
  • the challenges of informed consent, in a field where innovation is so rapid
  • the implications of traceability, when information may arise years after donation which could have significance for a donor or their family

SaBTO has identified principles and drawn up recommendations to support the development of cell-based advanced therapies and maximise donor and patient safety.