Body mass index (BMI) ≥35

Current FVIII inhibitors (\>0.6 Nijmegen Bethesda Units/mL) or prior Immune Tolerance Induction (ITI)

History of allergic reaction or anaphylaxis to recombinant FVIII products or SIG-001 components

Evidence of any bleeding disorder in addition to haemophilia A

Abnormal laboratory values as defined in the protocol

Active infection with Hepatitis B or Hepatitis C virus or currently managed with antiviral medications for Hepatitis B or C

Uncontrolled HIV infection

Active alcoholism or drug addiction during the 12 months before the screening visit

Active malignancy or history of malignancy in the 5 years prior to study entry

Participation in another investigational medicine or device study

Prior administration of a gene therapy product

Significant underlying disease or comorbidities that are a contraindication for general anaesthesia or laparoscopic procedure

Safety & Efficacy of Encapsulated Allogeneic FVIII Cell Therapy in Haemophilia A