Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of VX-880 in T1D Subjects
Research type
Research Study
Full title
A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of VX-880 in Subjects Who Have Type 1 Diabetes Mellitus With Impaired Hypoglycemic Awareness and Severe Hypoglycemia
IRAS ID
1006463
Contact name
Kari Forsaith
Contact email
Sponsor organisation
Vertex Pharmaceuticals Incorporated
Eudract number
2022-002292-11
Clinicaltrials.gov Identifier
Research summary
Type 1 diabetes (T1D) is a chronic condition that affects nearly 1.6 million people in the US and more than an estimated 900,000 people in Europe. T1D results from the destruction of insulin-producing pancreatic β-cells by an autoimmune process leading to insulin deficiency and hyperglycemia. Patients with T1D are dependent on insulin replacement therapy to manage hyperglycemia, prevent life-threatening ketoacidosis, and delay other severe diabetes complications. However, despite best treatment and clinical management, many patients with T1D suffer from long-term vascular complications, including diabetic retinopathy and diabetic nephropathy with a reduced life expectancy of more than 10 years.
Vertex Pharmaceuticals, Inc is currently developing VX-880 as a new potential treatment for subjects who have T1D with impaired hypoglycemic awareness and severe hypoglycemia. VX-880 is composed of allogeneic human stem cell derived islets. VX-880 is intended to be transplanted into subjects with T1D via infusion into the portal vein in the context of a steroid-free immunosuppressive regimen.
Subjects will be followed in Study VX20-880-101 for 5 years after VX-880 infusion.REC name
London - West London & GTAC Research Ethics Committee
REC reference
22/LO/0839
Date of REC Opinion
25 Jan 2023
REC opinion
Further Information Favourable Opinion