Evidence map›Paper›PMID 20883542›Full record

ArticleAmerican journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons2010

Experience with a novel efalizumab-based immunosuppressive regimen to facilitate single donor islet cell transplantation.

N A Turgeon, J G Avila, J A Cano, J J Hutchinson, I R Badell, A J Page, A B Adams, M H Sears, P H Bowen, A D Kirk and 2 more

Registry-linked trialOpen access · hybridAbstract readComparative StudyControlled Clinical Trial
In one paragraph

Article in American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00133809 (Islet Transplantation in Type 1 Diabetes Using the Edmonton Protocol of Steroid Free Immunosuppression), which is not on this map. Cited by 50 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
50citing papers in PubMed, 1 pooled it
10.7field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00133809 phase2completednot on this map

Islet Transplantation in Type 1 Diabetes Using the Edmonton Protocol of Steroid Free Immunosuppression

TypeinterventionalSponsorEmory UniversityRan2002 to 2014Enrolled8ConditionsDiabetes Mellitus, Type 1ArmsTransplantation of Human Islets
3 · Its place in the literature

Who cites it

50 citing papers in PubMed, 1 synthesis or guideline pooled it, 105 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Review
  5. Article
  6. Review
  7. Therapeutic Advances in Diabetes, Autoimmune, and Neurological Diseases.International journal of molecular sciences · 2021
    Review
  8. Review
  9. Peritransplant VLA-4 blockade inhibits endogenous memory CD8 T cell infiltration into high-risk cardiac allografts and CTLA-4Ig resistant rejection.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2019
    Article
  10. Review
  11. Article
  12. Belatacept-Resistant Rejection Is Associated With CD28American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2017
    Article
  13. Article
  14. Selective Targeting of High-Affinity LFA-1 Does Not Augment Costimulation Blockade in a Nonhuman Primate Renal Transplantation Model.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2017
    Article
  15. Review
  16. IL-2-MediatedFrontiers in immunology · 2017
    Article
  17. Islet cell transplant: Update on current clinical trials.Current transplantation reports · 2016
    Article
  18. Review
  19. Review
  20. Anti-Leukocyte Function-Associated Antigen 1 Therapy in a Nonhuman Primate Renal Transplant Model of Costimulation Blockade-Resistant Rejection.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2016
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 1 institution in 1 country.

N A TurgeonEmory Transplant Center, Department of Surgery, Emory University, Atlanta, GA, USA. nturgeo@emory.edu
J G Avila
J A Cano
J J Hutchinson
I R Badell
A J Page
A B Adams
M H Sears
P H Bowen
A D Kirk
T C Pearson
C P Larsen
Emory University · US

Funding

CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR025008 · NCRR · EMORY UNIVERSITY · PI STEPHENS, DAVID S · 2007 to 2011
$29.0M
Atlanta Clinical and Translational Science Institute (ACTSI) RenewalUL1TR000454 · NCATS · EMORY UNIVERSITY · PI STEPHENS, DAVID S · 2012 to 2016
$25.8M
X LINKED NYSTAGMUS SYNDROME WITH FEATURES OF ALBINISMM01RR000039 · NCRR · EMORY UNIVERSITY · PI VACCARINO, VIOLA · 1985 to 2007
$21.3M
Clinical Refinement of islet transplantationU01AI089317 · NIAID · EMORY UNIVERSITY · PI TURGEON, NICOLE ANN · 2009 to 2011
$2.5M
NCATS NIH HHS UL1 TR000454NCRR NIH HHS M01 RR000039NCRR NIH HHS M01 RR0039NCRR NIH HHS UL1 RR025008NIAID NIH HHS U01 AI089317
6 · The paper itself

Abstract

Islet transplantation is an experimental therapy for selected patients with type 1 diabetes (T1DM). It remains limited by immunosuppressive drug toxicity, progressive loss of insulin independence, allosensitization and the need for multiple islet donors. We describe our experience with an efalizumab-based immunosuppressive regimen as compared to the prevailing standard regimen, the Edmonton protocol. Twelve patients with T1DM received islet transplants: eight were treated with the Edmonton protocol; four were treated with daclizumab induction, a 6-month course of tacrolimus, and maintenance with efalizumab and mycophenolate mofetil. The primary endpoint was insulin independence after one islet infusion. Only two Edmonton protocol treated patients achieved the primary endpoint; six required islets from multiple donors, and all experienced leukopenia, mouth ulcers, anemia, diarrhea and hypertransaminasemia. Four became allosensitized. All patients treated with the efalizumab-based regimen achieved insulin independence with normal hemoglobin A1c after a single islet cell infusion and remained insulin independent while on efalizumab. These patients experienced significantly fewer side effects and none became allosensitized. Trial continuation was terminated by withdrawal of efalizumab from the market. These data suggest that this efalizumab-based regimen prevents islet rejection, is well tolerated, and allows for single donor islet transplantation.

Indexed as

Tissue DonorsAdultAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedDaclizumabDiabetes Mellitus, Type 1Feasibility StudiesGraft RejectionHumansImmunoglobulin GImmunosuppressive AgentsInsulinIslets of Langerhans TransplantationMaleMiddle AgedPilot ProjectsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedDaclizumabefalizumabImmunoglobulin GImmunosuppressive AgentsInsulin

Identifiers

PMID20883542
PMCPMC3335736
OpenAlexW1715491950

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.