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Leuven Tolerogenic Protocol for Intestinal Transplantation

ConditionsOrgan TransplantationIntestine
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUniversitaire Ziekenhuizen KU Leuven

About this trial

An immunomodulatory protocol, experimentally-proven to promote T-regulatory dependent graft protective mechanisms was applied in a clinical cohort of 13 intestinal transplant recipients to activate - in a protolerogenic environment - T-regulatory cells.

This protocol is the standard of care in the investigators intestinal transplant programme since the first intestinal transplant was performed in october 2000.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

all patients awaiting intestinal transplantation

Disqualifiers

living donation

Trial population

All patients who underwent intestinal transplantation

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • intestinal transplantation

    Procedure/Surgery

Treatment groups

13 Participants
are divided into 1 treatment group
Group A: intestinal transplantation1 intervention

Trial outcomes

Primary outcomes

1

Survival

routine clinical follow-up and Kaplan Meier Analysis

Time frame
10 years

Secondary outcomes

1

T-regulatory cells CD4+ CD45RA- Foxp3hi

Peripheral blood mononuclear cells (PBMC's) isolation and flow cytometry

Time frame
10 years
2

rejection

routine endoscopical obtained ileal biopsies analysed for number of apoptotic bodies in the crypt

Time frame
10 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universitaire Ziekenhuizen KU Leuven

Lead sponsor

Source ClinicalTrials.gov
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