Clinical studies on the treatment of type 1 diabetes with device-encapsulated pancreatic precursor cells derived from human embryonic stem cells found that insulin output was insufficient for clinical benefit. We are conducting a phase 1/2, open-label, multicenter trial aimed at optimizing cell engraftment (ClinicalTrials.
Clinical studies on the treatment of type 1 diabetes with device-encapsulated pancreatic precursor cells derived from human embryonic stem cells found that insulin output was insufficient for clinical benefit. We are conducting a phase 1/2, open-label, multicenter trial aimed at optimizing cell engraftment . Here we report interim, 1-year outcomes in one study group that received 2–3-fold higher cell doses in devices with an optimized membrane perforation pattern.
Two recent studies tested the safety of PEC-Direct in immunosuppressed patients with T1D and reported the first clinical evidence for formation of functional β cells in the implants. Insulin-positive cells were identified in retrieved implants, and plasma C-peptide was detected after meal stimulation.
Inclusion criteria included men and non-pregnant women, a diagnosis of T1D for a minimum of 5 years, hypoglycemia unawareness or significant glycemic lability, a stable diabetes treatment regimen, willingness to use a CGM device and being an acceptable candidate for surgical implantation. A Clarke score ≥4 confirmed patients qualifying for study participation on the basis of hypoglycemia unawareness.
An MMTT was carried out 4 weeks before transplant and at 3-month post-transplant intervals. Blood was collected every 30 min for measurement of glycemia and C-peptide, with the purpose of identifying recipients who increased plasma C-peptide between baseline and month 6 and those who achieved a level >0.07 nmol l during a 12-month follow-up.
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