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.
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 3
- 主要终点
- Rate of device-related adverse events (AEs)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •follows those of the institutions' standard of care (cohort A) or care team's guidelines (cohort B).
排除标准
- •- follows those of the institutions' standard of care (cohort A) or care team's guidelines (cohort B).
研究组 & 干预措施
Cohort B: ENCRT-103-hPI only
Patients receive only an ENCRT implant (the intervention) and a drug for engraftment and immune management.
干预措施: ENCRT-103-hPI encompasses the ENC-103 device, which will be implanted once loaded with primary islet cargo. (Device)
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.
干预措施: ENCRT-103-hPI encompasses the ENC-103 device, which will be implanted once loaded with primary islet cargo. (Device)
结局指标
主要结局
Rate of device-related adverse events (AEs)
时间窗: 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.
次要结局
- Assessment of IEQ (islet equivalent) population present in explants(4 months)