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

Inclusion Criteria: * Males aged 18 years or older * Diagnosis of Haemophilia A defined as ≤2% FVIII activity * Greater than 150 exposure days to treatment with FVIII products * Use of reliable barrier contraception if applicable * Normal levels of von Willebrand factor (VWF) antigen * Able and willing to provide informed consent * Willing to withdraw from FVIII prophylaxis during specified periods in the study Exclusion Criteria: * 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