Evidence map›Paper›PMID 26433206›Full record

ArticleAmerican journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons2016

Long-Term Follow-Up of the Edmonton Protocol of Islet Transplantation in the United States.

D C Brennan, H A Kopetskie, P H Sayre, R Alejandro, E Cagliero, A M J Shapiro, J S Goldstein, M R DesMarais, S Booher, P J Bianchine

Registry-linked trialAbstract read
PubMed Publisher
In one paragraph

Article in American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01309022 (Immunosuppressive Medications for Previous Participants in Clinical Trial NIS01), which is not on this map. Cited by 80 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
80citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT01309022 no longer availablenot on this map

Immunosuppressive Medications for Previous Participants in Clinical Trial NIS01 (ITN005CT, NCT00014911)

Typeexpanded_accessSponsorNational Institute of Allergy and Infectious Diseases (NIAID)ConditionsDiabetes Mellitus, Type 1ArmsSirolimus, Tacrolimus, Mycophenolate mofetil, Mycophenolic acid
3 · Its place in the literature

Who cites it

80 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  11. The Last Mile in Beta-Cell Replacement Therapy for Type 1 Diabetes: Time to Grow Up.Transplant international : official journal of the European Society for Organ Transplantation · 2025
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20 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors.

D C BrennanWashington University School of Medicine in St. Louis, St. Louis, MO.
H A KopetskieRho Federal Systems Division, Chapel Hill, NC.
P H SayreImmune Tolerance Network, San Francisco, CA.
R AlejandroUniversity of Miami Leonard M. Miller School of Medicine, Miami, FL.
E CaglieroMassachusetts General Hospital/Harvard Medical School, Boston, MA.
A M J ShapiroUniversity of Alberta, Edmonton, AB, Canada.
J S GoldsteinNational Institute of Allergy and Infectious Diseases, Bethesda, MD.
M R DesMaraisImmune Tolerance Network, San Francisco, CA.
S BooherNational Institute of Allergy and Infectious Diseases, Bethesda, MD.
P J BianchineNational Institute of Allergy and Infectious Diseases, Bethesda, MD.

Funding

IMMUNE TOLERANCE NETWORK-266015416-266015416N01AI015416 · NIAID · REGENTS OF THE UNIVERSITY OF C · PI BLUESTONE, JEFFREY A · 2002 to 2006
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NIAID NIH HHS N01-AI-15416PHS HHS HSN272200800029C
6 · The paper itself

Abstract

We report the long-term follow-up of the efficacy and safety of islet transplantation in seven type 1 diabetic subjects from the United States enrolled in the multicenter international Edmonton Protocol who had persistent islet function after completion of the Edmonton Protocol. Subjects were followed up to 12 years with serial testing for sustained islet allograft function as measured by C-peptide. All seven subjects demonstrated continued islet function longer than a decade from the time of first islet transplantation. One subject remained insulin independent without the need for diabetic medications or supplemental transplants. One subject who was insulin-independent for over 8 years experienced graft failure 10.9 years after the first islet transplant. The remaining six subjects demonstrated continued islet function upon trial completion, although three had received a supplemental islet transplant each. At trial completion, five subjects were receiving insulin and two remained insulin independent, although one was treated with liraglutide. The median hemoglobin A1c was 6.3% (45 mmol/mol). All subjects experienced progressive decline in the C-peptide/glucose ratio. No patients experienced severe hypoglycemia, opportunistic infection, or lymphoma. Thus, although the rate and duration of insulin independence was low, the Edmonton Protocol was safe in the long term. Alternative approaches to islet transplantation are under investigation.

Indexed as

Graft SurvivalIslets of Langerhans TransplantationAdultBlood GlucoseC-PeptideDiabetes Mellitus, Type 1FemaleFollow-Up StudiesGlycated HemoglobinHumansHypoglycemiaHypoglycemic AgentsInsulinMaleMiddle AgedPrognosisBlood GlucoseC-PeptideGlycated HemoglobinHypoglycemic AgentsInsulinDiscipline: islet transplantationFocus: clinical trial, immunosuppressive regimensScope: clinical research/practice

Identifiers

PMID26433206

What OpenQuestion holds

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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.