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Leuven Tolerogenic Protocol for Intestinal Transplantation (LP)

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ClinicalTrials.gov Identifier: NCT02314949
Recruitment Status : Unknown
Verified July 2013 by Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Recruiting
First Posted : December 11, 2014
Last Update Posted : December 11, 2014
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Brief Summary:

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.


Condition or disease Intervention/treatment
Organ Transplantation Intestine Procedure: intestinal transplantation

Detailed Description:

The LP is a 4-step approach that aims to upregulate T-regulatory cells (T-Regs) by directly stimulating their development and removing stimuli that could suppress them, eventually creating an environment favorable for graft acceptance. This protocol has been based upon preclinical research perormfed in the investigators lab and has been implemented as standard of care since the inception of the clinical programma in 2000. Patients gave informed consent for Donor Specific Blood Transfusion. Ethical approval for collection of additional blood samples was granted by the local ethical committee (s56862).

Step 1. Donor-specific blood transfusion (DSBT). 400 mL of whole blood was collected from the donor at the time of procurement and was transfused systemically in the recipient prior to reperfusion.

Step 2. Avoiding high-dose steroids. After Intestinal Transplantation, only 16 mg of medrol was administered and tapered towards 4 mg in 3 to 6 months post-Tx, similar to the liver Tx protocol.

Step 3. Avoiding high-dose calcineurin inhibitors (tacrolimus). Initial levels of 15 ng/ml were tapered -within 3 to 6 months- to 5 ng/mL or less for liver-containing grafts and 6 to 8 ng/mL for isolated intestinal grafts.

Step 4. Maintaining mucosal integrity and reducing ischemia reperfusion injury, inflammation, and endotoxin translocation. This was obtained by selecting perfect (ischemia-free) donors (<50y, absence of significant hypotension, vasopressor requirement and cardiac arrest); pretreating donors with selective bowel decontamination and glutamine; gentle manipulations of the organs during donor and recipient surgery; aiming for short cold and warm ischemic times (5h and 30' respectively). Bowel decontamination consists of Nilstat, Tobramycine and Colimycine administered by a nasogastric tube and continued posttransplant during three months. Glutamine is supplemented parenterally (Dipeptiven Kabi Fresenius) and enterally (Alitracq) to donors and continued posttransplant.


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Study Type : Observational
Estimated Enrollment : 13 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Multifactorial Immunomodulatory Protocol -Promoting T-regulatory Cells- Prolongs Graft and Patient Survival After Intestinal Transplantation
Study Start Date : October 2000
Estimated Primary Completion Date : January 2015

Group/Cohort Intervention/treatment
intestinal transplantation
all performed intestinal transplants underwent the same Leuven intestinal transplant protocol
Procedure: intestinal transplantation



Primary Outcome Measures :
  1. Survival [ Time Frame: 10 years ]
    routine clinical follow-up and Kaplan Meier Analysis


Secondary Outcome Measures :
  1. T-regulatory cells CD4+ CD45RA- Foxp3hi [ Time Frame: 10 years ]
    Peripheral blood mononuclear cells (PBMC's) isolation and flow cytometry

  2. rejection [ Time Frame: 10 years ]
    routine endoscopical obtained ileal biopsies analysed for number of apoptotic bodies in the crypt



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients who underwent intestinal transplantation
Criteria

Inclusion Criteria:

  • all patients awaiting intestinal transplantation

Exclusion Criteria:

  • living donation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02314949


Contacts
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Contact: Jacques Pirenne, MD,PhD,MsC +32 16 34 87 27 jacques.pirenne@uzleuven.be
Contact: Laurens J Ceulemans, MD +32 16 34 15 45 laurens.ceulemans@uzleuven.be

Locations
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Belgium
UZ Leuven Recruiting
Leuven, Belgium, 3000
Contact: Sarah Mertens    +32 16 34 29 61    sarah.mertens@uzleuven.be   
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02314949     History of Changes
Other Study ID Numbers: LPs56862
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: December 11, 2014
Last Verified: July 2013

Keywords provided by Universitaire Ziekenhuizen Leuven:
T-regulatory cells
Tolerogenic protocol
immunomodulation