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Novel Method of Pancreatic Islet Transplantation Into the Omentum

NCT04884633 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2021-08-31

No results posted yet for this study

Summary

The investigators propose to conduct a pilot clinical study in 10 type 1 diabetic subjects suffering from hypoglycemia unawareness syndrome and episodes of severe hypoglycemia, in which therapy with transplantation of allogeneic pancreatic islets would be indicated according to current criteria at the Institute for Clinical and Experimental Medicine (IKEM). Pancreatic islets will be isolated and prepared for transplantation using the established laboratory technique with minor modifications corresponding to latest knowledge. In contrast to present routine, the islet preparation will not be administered percutaneously into the portal vein but will be placed on the surface of an omental pouch using a (mini) laparoscopic approach. Cell adherence will be achieved by addition of clinical-grade human thrombin that reacts with plasma to create a biocompatible, degradable gel containing the islet graft. The study will be performed in close collaboration with the Diabetes Research Institute (DRI) in Miami, which will provide expert assistance and technical training if needed.

Conditions

  • Islets of Langerhans Transplantation

Interventions

PROCEDURE

Pancreatic islet transplantation

New method of pancreatic islet transplantation into the omentum using a biodegradable scaffold

Sponsors & Collaborators

  • Frantisek Saudek

    lead OTHER_GOV

Principal Investigators

  • Frantisek Saudek · Institute for Clinical and Experimental Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2019-08-15
Primary Completion
2022-12-31
Completion
2023-08-31

Countries

  • Czechia

Study Locations

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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 NCT04884633 on ClinicalTrials.gov