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Pancreatic Islet Transplantation to the Anterior Chamber of the Eye

NCT04198350 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-09-03

No results posted yet for this study

Summary

This is a phase II prospective, interventional, open-labeled, proof-of-concept study.

2 years per participant, 2 years 6 months in total Total n=6

The primary objective is to assess the safety of human pancreatic islet transplantation into the ACE of participants with T1D.

Safety analyses will involve examination of the incidence, severity, and type of treatment emergent AEs reported, and changes in vital signs, ophthalmic status and laboratory test results from baseline (Day 0 pre-transplantation) to specified time points throughout the study.

Conditions

Interventions

PROCEDURE

Islet implantation

Transplantation of allogeneic pancreatic human islets will be performed into the anterior chamber of a single eye with the poorest visual acuity (see inclusion/exclusion criteria below). Up to 40 000 IEQ of islets in a maximum volume of 350µl will be transplanted.

Sponsors & Collaborators

  • Imperial College London

    lead OTHER

Principal Investigators

  • Nick Oliver · Imperial College London

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2025-08-31
Completion
2025-08-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04198350 on ClinicalTrials.gov