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.
Key facts
- Where
- Toronto és Vancouver, KanadaSee the 2 sites
- Phase
- 1. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Forrás: NCT07680673: ki vehet részt
Where in Kanada
- UHNToronto, KanadaNo longer taking part
- Vancouver General HospitalVancouver, KanadaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Encellin
- Trial code
- NCT07680673
- Record updated
- 2026. augusztus 20.
- Original description
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.Read full original descriptionShow less
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.
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.
Inclusion: follows those of the institutions' standard of care (cohort A) or care team's guidelines (cohort B).
Exclusion: - follows those of the institutions' standard of care (cohort A) or care team's guidelines (cohort B).