Safety and function of a new pre-vascularized bioartificial pancreas in an allogeneic rat model

Author:

Magisson Jordan1,Sassi Aladin1,Xhema Daela2,Kobalyan Aram1,Gianello Pierre2,Mourer Brice3,Tran Nguyen3,Burcez Charles-Thibault1,Bou Aoun Richard1,Sigrist Séverine1ORCID

Affiliation:

1. Defymed SAS, Strasbourg, France

2. Laboratory of Experimental Surgery, Université Catholique de Louvain, Brussels, Belgium

3. Ecole de Chirurgie de Nancy-Lorraine, Vandoeuvre-lès-Nancy, France

Abstract

Cell encapsulation could overcome limitations of free islets transplantation but is currently limited by inefficient cells immune protection and hypoxia. As a response to these challenges, we tested in vitro and in vivo the safety and efficacy of a new macroencapsulation device named MailPan®. Membranes of MailPan® device were tested in vitro in static conditions. Its bio-integration and level of oxygenation was assessed after implantation in non-diabetic rats. Immune protection properties were also assessed in rat with injection in the device of allogeneic islets with incompatible Major Histocompatibility Complex. Finally, function was assessed in diabetic rats with a Beta cell line injected in MailPan®. In vitro, membranes of the device showed high permeability to glucose, insulin, and rejected IgG. In rat, the device displayed good bio-integration, efficient vascularization, and satisfactory oxygenation (>5%), while positron emission tomography (PET)-scan and angiography also highlighted rapid exchanges between blood circulation and the MailPan®. The device showed its immune protection properties by preventing formation, by the rat recipient, of antibodies against encapsulated allogenic islets. Injection of a rat beta cell line into the device normalized fasting glycemia of diabetic rat with retrieval of viable cell clusters after 2 months. These data suggest that MailPan® constitutes a promising encapsulation device for widespread use of cell therapy for type 1 diabetes.

Funder

Fonds Unique Interministériel

Région Grand Est

Juvenile Diabetes Research Foundation

Metropole du Grand Nancy

Publisher

SAGE Publications

Subject

Biomedical Engineering,Biomaterials,Medicine (miscellaneous)

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