PROLONGSTEM

• Research type

  Research Study

• Full title

  HepaStem Long-Term Safety Registry : Registry for patients who have been administered HepaStem

• IRAS ID

  238603

• Contact name

  Stephanie Grunewald

• Sponsor organisation

  Promethera Biosciences

• Eudract number

  2017-003989-27

• Duration of Study in the UK

  5 years, 0 months, 1 days

• Research summary

  Prospective, longitudinal, observational, long-term safety follow-up of patients having received at least 1 infusion of HepaStem.
  Patients who previously received the IMP HepaStem in the context of an interventional study with HepaStem administration will be followed-up for long-term safety surveillance up to 5 years in this PROLONGSTEM study. During this study, only Adverse Event of Special Interest will be collected to assess the long term safety post Hepastem administration.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  18/LO/0620

• Date of REC Opinion

  10 Jul 2018

• REC opinion

  Further Information Favourable Opinion