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.

Официальное название

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

Обзор

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.

Подробное описание

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 special access 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.

Вмешательства

• Устройство ENCRT-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.

Первичные конечные точки

• Rate of device-related adverse events (AEs) [Срок оценки: 4.5-5 months]

Вторичные конечные точки (1)

• Assessment of IEQ (islet equivalent) population present in explants [Срок оценки: 4 months]

Критерии участия

Критерии включения

• follows those of the institutions' standard of care (cohort A) or care team's guidelines (cohort B).

Критерии исключения

• \- follows those of the institutions' standard of care (cohort A) or care team's guidelines (cohort B).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Оценка устройства

Центры проведения

Канада · 3 центра

• Vancouver General Hospital — Vancouver
• UHN — Toronto
• McGill University Health Centre — Montreal

Идентификаторы

NCT: NCT07680673 · ENCRT-103-hPI · 2-IND-2026-1973-I-X

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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