DiabeCell Phase IIb trial initiated following strong interim Phase IIa results
Results from an interim analysis of Living Cell Technologies' (LCT) Argentinian Phase I/IIa trial of DiabeCell, encapsulated porcine islets for the treatment of unstable Type I diabetes, have demonstrated a clinically-significant reduction in HbA1c, insulin dose and unaware hypoglycaemia, with greater benefit being seen in the patient group receiving the higher dose of DiabeCell.
The trial, which is ongoing, involves eight patients split into two groups of four. Group one received two 5,000 IEQ/kg doses of DiabeCell and group two received two 10,000 IEQ/kg doses. In both groups, the second dose was implanted 12 weeks after the first. At the time of this interim analysis, group one patients were at 24 weeks follow-up after the second transplant and group two patients were at 12 weeks follow-up after the second transplant.
In the second group of patients (those receiving 10,000 IEQ/kg) the most significant clinical benefits were: