Type 1 Diabetes
Conditions
Keywords
islets, islet cell transplantation islet transplantation, Diabetes Mellitus, Diabetes Mellitus Type 1, Glucose Metabolism
Brief summary
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.
Detailed description
This study is a dual-arm, three-centre, non-randomized, FIH trial that will evaluate the safety of the ENCRT-103-hPI in patients with T1D. Study subjects may be receiving standard of care islet infusion (cohort A), or not (cohort B). Cohort B will receive a different drug regimen compared to cohort A's standard of care immune management. Both cohorts will experience equivalent processes: donor matching, comparable ENCRT-103-hPI dosages, implant into the upper arm or abdomen, explant at 4 mo and post surgical followup. 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. The secondary objectives are to evaluate of the activity, function, and survival of the donor islets from the retrieved ENCRT-103-hPI. The exploratory objectives include measures of circulating and stimulated C-peptide, HbA1c, insulin use doses, and when available, CGM trends.
Interventions
DEVICEENCRT-103-hPI encompasses the ENC-103 device, which will be implanted once loaded with primary islet cargo.
The 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.
Sponsors
Encellin
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* follows those of the institutions' standard of care (cohort A) or care team's guidelines (cohort B).
Exclusion criteria
* \- follows those of the institutions' standard of care (cohort A) or care team's guidelines (cohort B).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of device-related adverse events (AEs) | 4.5-5 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of IEQ (islet equivalent) population present in explants | 4 months | 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. |
Countries
Canada
Outcome results
None listed