Who is sponsoring NCT04884633?

NCT04884633 is sponsored by Frantisek Saudek.

What drugs are being tested in NCT04884633?

Interventions in NCT04884633: Pancreatic islet transplantation.

What condition does NCT04884633 study?

NCT04884633 studies Islets of Langerhans Transplantation.

Is NCT04884633 still recruiting?

NCT04884633 is currently status unknown. Last updated 31 August 2021.

Last reviewed 2021-08-31 · How we verify

NCT04884633

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Novel Method of Pancreatic Islet Transplantation Into the Omentum

Status unknown NA Last updated 31 August 2021

What this trial tests

NA trial testing Pancreatic islet transplantation in Islets of Langerhans Transplantation in 6 participants. Status unknown.

Timeline

15 August 2019

Primary endpoint
31 December 2022

31 August 2023

Quick facts

Lead sponsor	Frantisek Saudek
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	6
Start date	15 August 2019
Primary completion	31 December 2022
Estimated completion	31 August 2023
Sites	1 location across Czechia

Drugs / interventions tested

Pancreatic islet transplantation

Conditions studied

Islets of Langerhans Transplantation — all drugs for Islets of Langerhans Transplantation →

Sponsor

Frantisek Saudek

Who can join

Adults 18 to 65, any sex, with Islets of Langerhans Transplantation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other Frantisek Saudek trials

Trials by the same sponsor.

NCT01050166 — MRI Imaging of Labeled Human Islets Transplanted Into the Liver · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04884633 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Frantisek Saudek
Last refreshed: 31 August 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04884633.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing