ENCRT-103-hPI: Evaluation of an Immune-protected ENCRT-103-hPI Containing Primary Human Islets in Adults With Type 1 Diabetes, With and Without Standard-of-care Portal Vein Islet Infusion.

Sponsor
Encellin
Study ID
NCT07680673
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • ENCRT-103-hPI encompasses the ENC-103 device, which will be implanted once loaded with primary islet cargo. — DEVICE
    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.

Study Details

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.

Key Dates

First listed
Jul 2, 2026
Start date
Jan 6, 2027
Status verified
Jul 2026
Primary completion
Jul 6, 2028
Completion
Jan 31, 2029

Study Design

Enrollment
10 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: Cohort A: ENCRT-103-hPI with standard of care
    Patients receive standard of care islet infusion and the intervention of an ENCRT implant on the same day. Cohort A also receives standard of care drug regimen for immune management.
  • Experimental: Cohort B: ENCRT-103-hPI only
    Patients receive only an ENCRT implant (the intervention) and a special access drug regimen for immune management.

Primary Outcome Measure

Rate of device-related adverse events (AEs) [ Time Frame: 4.5-5 months ]

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