Safety and Efficacy of Encapsulated Allogeneic MPS-1 Therapy

Inclusion Criteria: * Able and willing to provide informed consent * Male or female aged 18 or older * Diagnosis of attenuated MPS-1 (Hurler-Scheie or Scheie) * Alpha-L-iduronidase enzyme activity level of less than 10% of the lower limit of the normal range * Prior treatment with ERT * Willing to transition from ERT to SIG-005 * Female patients of childbearing potential with negative pregnancy test * Use of highly effective method of contraception if applicable Exclusion Criteria: * A diagnosis of severe MPS-1 * Previous haematopoietic stem cell transplantation (HSCT) * History of elevated total (IgG) anti-IDUA antibody * Use of assistive respiratory devices * Unable to walk independently * History of allergic reaction or anaphylaxis to recombinant hIDUA * Body mass index (BMI) ≥35 * History of abdominal adhesions, medical history of Crohn's disease, inflammatory bowel disease or any disease that increases the risk of post-operative abdominal adhesions * Significant underlying disease or comorbidities that are a contraindication for general anaesthesia or laparoscopic procedure * Pregnant or lactating patients * Prior administration of a gene therapy product * Participation in another investigational medicine or device study * Abnormal laboratory values as defined in the protocol * 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 * Recent COVID-19 infection:…