Organ Transplantation Clinical Trial
Official title:
A Multifactorial Immunomodulatory Protocol -Promoting T-regulatory Cells- Prolongs Graft and Patient Survival After Intestinal Transplantation
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.
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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Observational Model: Cohort, Time Perspective: Retrospective
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