INSULIN INDEPENDENCE IN ISLET AFTER KIDNEY ALLOGENEIC TRANSPLANTATION USING A STEROID-FREE PROTOCOL.
Bibliographic record
Abstract
P442 Aims: The Edmonton protocol has markedly improved the rate of success of islet transplantation (Tx) in non-uremic patients with labile type 1 diabetes. The aim of this study was to assess the efficiency and safety of a sirolimus-based steroid free immunosuppressive regimen in islet after kidney (IAK) transplant recipients. Methods: Ten islet infusions were administered to 6 patients with type 1 diabetes previously transplanted with a kidney. In one case, islets isolated from 2 different donors were pooled for infusion. Islets were isolated with the automated method. Target islet equivalent number was 10,000/kg body weight administered in 2 infusions if necessary. An immunosuppressive regimen associating Sirolimus-Tacrolimus-Daclizumab was used in all patients. Tapering of steroids was started at the time of enlistment, and patients were transplanted only if their daily dose of prednisone was < 5 mg. All patients were on TMP/SMX and valganciclovir prophylaxis after transplantation. Results: Insulin independence was achieved in all patients but one, who is still expecting a second infusion. Of 3 patients who have reached 1 year follow-up, 2 are still off insulin. Mean pre-Tx values compared to values at 1 year were: insulin requirements 34 vs 4.7 units, basal C-peptide 0.1 vs 2.54 ng/ml, HbA1c 7.5 vs 6.6%, fructosamine 347 vs 274 pmol/l (p<0.05 for all values). Severe adverse events included bleeding after percutaneous portal access (N=2), severe pneumonia attributed to sirolimus toxicity (N=1), kidney graft loss after IS discontinuation (N=1), and reversible kidney graft rejection (N=1). Other adverse events included dyslipidemia requiring statin therapy (5/6), mouth ulcerations (4/6), leukopenia (5/6), diarrhea (4/6) and polyarthritis requiring steroid therapy (N=1). Significant infectious side effects included urinary tract infection (N=3), fungal dermatitis (N=1), and anal-genital herpes (N=1). No CMV or EBV infections were recorded. Conclusions: These data indicate that the Edmonton protocol of immunosuppression can be successfully applied to recipients of IAK grafts. Additional issues pertaining to kidney graft function must be considered. Side effects of the IS regimen are significant.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.001 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".