Next Step to Alleviating T1D - PAGE UPDATED 5/16
ViaCyte formerly Novocell Inc. , a leader in regenerative medical devices out of San Diego, CA, has filed an application with the FDA to begin Phase1 / 2 human Clinical Trials in patients with T1D.
The Encaptra (VC-01) delivery system is an encapsulation device that operates much the same way as a human healthy pancreas. The device is about the size of a band-aid containing progenitor stem cells (PEC-01) that develop into pancreatic cells with the ability to respond to blood sugar levels and produce the hormones, insulin, glucagon, amylin needed to control shifts in BG. The beauty of this system is the ability of the capsule to mask the existence of these cells from the body’s defensive mechanism.
The very auto-antibodies that caused T1D or antibodies developed in response to a foreign substance are unable to reach the contained cells while allowing for an exchange of fluids through a semi-permeable membrane. This means that the dreaded use of immunosuppressive agents will be unnecessary during the systems operation estimated to last between 1 and 5 years at which time it would need to be replaced through a simple outpatient surgical procedure. Assuming FDA approval, watch for regions where clinical trials will be held at clinicaltrials.gov . This research is being supported by JDRF. An article written in Diabetes Mine reflects on four other companies presently working on encapsulation devices.
ViaCyte is currently running a safety, tolerability and efficacy study of VC-01 combination product in subjects with T1D.