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Company Publishes "Trial Considerations" For Stem Cell Diabetes Therapy.

GERMANTOWN, Md., November 12, 2018-Regenerative medicine company Seraxis Inc., announced the publication of "important trial considerations" for SR-01, its pluripotent stem cell -derived islet therapy for insulin-dependent diabetes.

An analysis of islet transplant trials registered on was conducted with the goal of extracting insights to apply in the study design of Seraxis lead candidate, SR-01 for the treatment of type 1 diabetes.

The results of this analysis ("Concise Review: Lessons Learned from Islet Transplant Clinical Trials in Developing Stem Cell Therapies for Type 1 Diabetes") were published 12 November 2018 in Stem Cells Translational Medicine (

The authors (Welsch et al.) concluded, in part:

"An examination of the CTgov registrations for islet transplantation highlights current bottlenecks to broader use of islet transplantation for treatment of T1D. These bottlenecks include poor islet survival and significant side-effects, many associated with obligate pharmacologic immunosuppression...

"Because of the small numbers of islet transplantations performed and regulatory hurdles inherent in first-in-human trials, these promising therapies will take time to evaluate, but all represent potential major improvements toward more optimal use of islets for treatment of T1D."

SR-01 is a combination therapy of insulinproducing cells encapsulated in the retrievable biocompatible SeraGraft device, designed to prevent immune system access to the cells after implantation.

The SeraGraft device has been shown to protect encapsulated cells in immune-competent diabetic models, to facilitate rapid vascularization of the graft without inducing a fibrotic response.

If successful, SR-01 cell replacement therapy has the potential to provide a novel therapeutic modality to insulin-dependent type 1 diabetes patients, and Seraxis is establishing a strategic relationship with a major clinical transplant program toward that end.

The Seraxis therapy could overcome some of the challenges associated with current pancreatic islet transplant protocols, providing a theoretically unlimited supply of insulin-producing cells and reducing or eliminating the need for post-transplant pharmacologic immunosuppression.

Privately-held Seraxis, incorporated in Singapore and in the U.S., used proprietary technologies to develop: a cell therapy that functions shortly after transplantation in diabetic animals and; a device, SeraGraft, that safely protects these human pancreas cells from the immune system of animal hosts without need for pharmacologic immunosuppression.


Contact: Marie Csete,

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Title Annotation:Clinical Trials
Publication:Stem Cell Lab World
Date:Nov 12, 2018
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