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Treatment of Type I Diabetes by Islet Transplantation Into the Gastric Submucosa Study Protocol

NCT02402439 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2023-08-14

No results posted yet for this study

Summary

The goal of this trial is to gain initial clinical experience regarding the safety and efficacy of treating type I diabetes in people who have received a kidney transplant by transplanting islets into a new transplant site in the stomach (gastrointestinal submucosa). A total of 6 patients will be enrolled in the study and followed for a period of up to 3 years after the last islet transplant.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DRUG

Islet cells

Transplantation of islets into the gastrointestinal submucosa

PROCEDURE

Islet transplantation into the gastrointestinal submucosa

Transplantation of islets into the gastrointestinal submucosa

Sponsors & Collaborators

  • Andrew Posselt

    lead OTHER

Principal Investigators

  • Andrew M Posselt, MD, PhD · University of California, San Francisco

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2024-04-30
Completion
2024-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT02402439 on ClinicalTrials.gov