SAF001
Research type
Research Study
Full title
SAF 001: A long-term safety follow-up study of patients having received infusions of HepaStem.
IRAS ID
147764
Contact name
Stephanie Grunewald
Contact email
Sponsor organisation
Promethera Biosciences
Eudract number
2013-001045-14
Clinicaltrials.gov Identifier
MCRN - 3298, Medicine for Children Research Network
Research summary
All patients having received HepaStem in any former interventional (in the UK at time of intial submission UKHEP001) study conducted by the sponsor will be invited to enter the long term safety follow-up study SAF001. When the patient is ending his/her participation in the former interventional study, the patient will be enrolled in the SAF001 study if the eligibility criteria are met and if a written informed consent is given.
REC name
London - Central Research Ethics Committee
REC reference
14/LO/1066
Date of REC Opinion
30 Jul 2014
REC opinion
Further Information Favourable Opinion