A phase 1/2, prospective, single arm study to investigate the Cell Pouch System of Islet transplantation for treatment of type 1 diabetes (T1D) in individuals with hypoglycemia unawareness.
Phase of Trial: Phase I/II
Latest Information Update: 15 Dec 2017
At a glance
- Drugs Islet cell replacement therapy (Primary)
- Indications Type 1 diabetes mellitus
- Focus Adverse reactions
- Sponsors Sernova Corp
- 15 Dec 2017 New trial record
- 11 Dec 2017 According to a Sernova media release, company has received US Food and Drug Administration (FDA) notice of allowance for its IND for a new human clinical trial with the Cell Pouch System (TM) (CPS) in the United States.