FDA places hold on trial of novel cell therapy for type 1 diabetes

The FDA has halted a clinical trial for an investigational stem cell-derived therapy for people with type 1 diabetes, according to an industry press release.
VX-880 (Vertex Pharmaceuticals), a novel investigational stem cell-derived pancreatic islet cell replacement therapy for people with type 1 diabetes with impaired hypoglycemia awareness and severe hypoglycemia, was placed on a clinical hold by the FDA due to insufficient data to support dose escalation.
“We are surprised by the clinical hold placed on the study,” Carmen Bozic, MD, executive vice president of global medicines

The FDA has halted a clinical trial for an investigational stem cell-derived therapy for people with type 1 diabetes, according to an industry press release.
VX-880 (Vertex Pharmaceuticals), a novel investigational stem cell-derived pancreatic islet cell replacement therapy for people with type 1 diabetes with impaired hypoglycemia awareness and severe hypoglycemia, was placed on a clinical hold by the FDA due to insufficient data to support dose escalation.
“We are surprised by the clinical hold placed on the study,” Carmen Bozic, MD, executive vice president of global medicines