Endocrinology

All patients showed improved glycemic control and a reduction in insulin independence.

The phase 1/2 trial features 3 phases, with new sites expected to open in the coming months. VX-264 uses the same stem cell-derived islets used in the VX-880 program in type 1 diabetes.

The 2 patients were among 6 who have received treatment in Vertex’s trial so far and were the only 2 evaluable for the primary efficacy end point.

Five patients in the cohort achieved this milestone and Sernova noted a sixth patient in the cohort is still awaiting assessment of islet graft function.

With an original PDUFA date in August 2021, the decision is a long time coming.

The study of VX-264, a stem cell-derived, fully differentiated pancreatic islet cell therapy, is already ongoing in Canada. It is expected to kick off in the United States in the first half of 2023.

The trial will take place at the University of Miami Health System and will be carried out in collaboration with the Diabetes Research Institute.

No adverse events related to the infusions of stromal cells were reported.

Several of the first cohort patients have had their Cell Pouch implants for over 3 years and no patients have elected to have their implants removed.

AlloStem will be evaluated in the CELZ-201 clinical trial for patients with newly diagnosed type 1 diabetes.

The FDA has lifted a clinical hold on the trial of VX880 placed in May 2022 due to insufficient information.

The director of the Alleghany Health Network Institute of Cellular Therapeutics discussed possible applications of the procedure.

The director of the Alleghany Health Network Institute of Cellular Therapeutics discussed islet cell transplant for the treatment of chronic pancreatitis.

The phase 1/2 trial of VX880 remains on clinical hold in the US.

Investigators from Seattle Children’s Hospital found that engineered T-cell regulatory products demonstrated significant suppression of effector T cells.

Investigators in Ukraine share data on the safety and efficacy of autologous mesenchymal stem cell administration for type 2 diabetes complications under the hypothesis that success is dependent on the administration route and quality of the autologous MSC population.

The company reports positive data from first 2 patients dosed, but the agency determined there is insufficient information to support dose escalation.

The Director of the Islet Transplant Program at the University of Alberta discussed the implantable VC-02 device's success in type 1 diabetes.

The reprioritization comes as the SIG-001 program remains on clinical hold after scarred and inviable cell spheres were observed in a treated patient.

The patient’s daily insulin requirement went from 34 units a day at baseline to 2.9 units a day 90 days after treatment.

An interim analysis has met prespecified safety and efficacy checkpoints.

Both Vertex and Arbor are adding to their list of gene and cell therapy partnerships with the announcement.

Study examining the role of IL-17A in patients with diabetes.

Selected abstracts from the American Diabetes Association's 80th Scientific Sessions discuss when to add injectable therapy, how patients who switched to semaglutide lost more weight and gained glycemic control, and offered results from an early-phase study on a monoclonal antibody that may preserve B-cell function.

A biomarker for pancreatic precursor cells might give researchers a shortcut to create insulin-producing beta cells that can be transplanted into patients with type 1 diabetes.