This study will evaluate the safety and performance of ENCRT-103-hPI, which is a cargo of primary islets inside Encellin's ENC-103-CED. The 103 offers a soft pillow-like encasing to contain and protect the cells from the immune system. The product is implanted in the upper arm or abdomen and is approximately the size of a quarter. Eligibility is open to both patients on a standard of care islet infusion wait list, as well as those who are not. Participation in this trial does not preclude future Encellin trial participation. The study duration is 4.5months and requires keeping the implant for 4 months, as well as adhering to a standard of care schedule of follow ups during the implant period.
follows those of the institutions' standard of care (cohort A) or care team's guidelines (cohort B).
- follows those of the institutions' standard of care (cohort A) or care team's guidelines (cohort B).
Parallel
ENCRT-103-hPI encompasses the ENC-103 device, which will be implanted once loaded with primary islet cargo.
DeviceThe ENC-103-CED is a unique device on the landscape. It is a soft, device made of non-fibrosis inducing material and design features. ENCRT-103-hPI that will be implanted consists of this device loaded with primary islets. Both cohorts A and B will receive the intervention of an ENCRT-103-hPI implant.
Rate of device-related adverse events (AEs)
The primary objective is to evaluate the safety, tolerability, and local tissue response of fully immune-protected ENCRT devices containing primary human islets in adults with Type 1 Diabetes. Included in assessments are vascular integration and immune cell exclusion.
Assessment of IEQ (islet equivalent) population present in explants
The secondary objectives are to evaluate of the activity, function, and survival of the donor islets from the retrieved ENCRT-103-hPI through marker expression in histological sections.
Exploratory functional outcomes
Characterize potential functional engraftment via device removal and fixation for histopathological analysis (post-explant).
This trial is not recruiting at the moment. You can still explore other options:
