For the first time ever, an ES cell-based device has been transplanted into a Diabetic patient.
ViaCyte working together with Dr. Robert Henry at UCSD did the pioneering transplant, the first in a series as part of an FDA-approved clinical trial being conducted as UCSD Health System.
The trial is a combined Phase I/II testing the safety of ViaCyte’s VC-01 product.
The PR says, “In an open-label, dose-escalating format, ViaCyte expects to enroll approximately 40 patients in the study at multiple clinical sites.” It is entitled “A Safety, Tolerability, and Efficacy Study of VC-01™ Combination Product in Subjects With Type I Diabetes Mellitus.”
VC-01 employs human pancreatic progenitor cells derived from human ES cells. The rationale here is that in preclinical studies the cells were shown to have a significantly positive influence on blood sugar in Diabetic mice.
This is an exciting, positive development for the field and for patients. I can’t wait to see how the trial goes and am cautiously hopeful.