NCT01652911

A Phase I/II Study of the Safety and Efficacy of Sernova's Cell PouchTM for Therapeutic Islet Transplantation

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: University of Alberta · Academic / Other
• Sex: All
• Age: 18 Years – 68 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, single arm, non-randomized safety and efficacy study, where participants with Type-1 diabetes will receive the Sernova Cell Pouch™ implanted in the subcutaneous site, two to approximately twelve weeks prior to transplantation of islets into the Cell Pouch™. The primary objective of this study is to assess the safety of the Sernova Cell Pouch™ in adult participants with Type-1 diabetes receiving islet transplantation for the first time. Secondary objectives are the following: 1. To determine the proportion of subjects implanted with the Cell Pouch™ and transplanted with islets into the Cell Pouch™ who achieve and maintain insulin independence after islet transplantation. 2. To obtain preliminary data on the efficacy of the Cell Pouch™ to maintain adequate immunological protection against both allo- and autoimmunity of islet transplant recipients. 3. To determine through retrospective analysis comparative metabolic function and engraftment efficiency using patients undergoing standard intraportal islet transplantation under the current alemtuzumab standard of care protocol.

Conditions

• Type I Diabetes

Interventions

Type	Name	Description
DEVICE	Sernova Cell Pouch	The Cell Pouch™ is an implantable medical device for transplantation of donor islets for Type-1 diabetes as an alternative to the current standard of care using intraportal delivery of islets.

Timeline

• Start date: 2012-06-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2012-07-30
• Last updated: 2022-05-11

Locations

1 site across 1 country: Canada