Evidence mapPaperPMID 32627352Full record

Trial reportAmerican journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons2021

Phase 3 trial of human islet-after-kidney transplantation in type 1 diabetes.

James F Markmann, Michael R Rickels, Thomas L Eggerman, Nancy D Bridges, David E Lafontant, Julie Qidwai, Eric Foster, William R Clarke, Malek Kamoun, Rodolfo Alejandro and 18 more

Abstract readClinical Trial, Phase III
In one paragraph

Trial report in American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 48 papers.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

48 citing papers in PubMed.

  1. Feasibility and efficacy of combined pancreatic islet-lung transplantation in cystic fibrosis-related diabetes-PIM study: A multicenter phase 1-2 trial.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2022
    Trial
  2. Review
  3. Article
  4. Article
  5. Review
  6. Article
  7. Review
  8. Article
  9. Article
  10. Review
  11. Cell Therapy for T1D Beyond BLA: Gearing Up Toward Clinical Practice.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2025
    Review
  12. Article
  13. Islet Cell Replacement and Regeneration for Type 1 Diabetes: Current Developments and Future Prospects.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025
    Review
  14. Article
  15. Review
  16. Article
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  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

28 authors.

James F MarkmannDivision of Transplant Surgery, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.ORCID 0000-0002-2762-6535
Michael R RickelsDivision of Endocrinology, Diabetes & Metabolism, Department of Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.ORCID 0000-0002-9253-838X
Thomas L EggermanNational Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland, USA.
Nancy D BridgesNational Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.
David E LafontantClinical Trials Statistical and Data Management Center, University of Iowa, Iowa City, Iowa, USA.
Julie QidwaiClinical Trials Statistical and Data Management Center, University of Iowa, Iowa City, Iowa, USA.
Eric FosterFerring Pharmaceuticals, Parsippany, New Jersey, USA.
William R ClarkeClinical Trials Statistical and Data Management Center, University of Iowa, Iowa City, Iowa, USA.
Malek KamounDepartment of Pathology and Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Rodolfo AlejandroDiabetes Research Institute and Clinical Cell Transplant Program, University of Miami Miller School of Medicine, Miami, Florida, USA.ORCID 0000-0003-4387-5360
Melena D BellinDepartment of Endocrinology, University of Minnesota, Minneapolis, Minnesota, USA.
Kathryn ChalonerClinical Trials Statistical and Data Management Center, University of Iowa, Iowa City, Iowa, USA.
Christine W CzarnieckiNational Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.
Julia S GoldsteinNational Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.
Bernhard J HeringSchulze Diabetes Institute and Department of Surgery, University of Minnesota, Minneapolis, Minnesota, USA.
Lawrence G HunsickerClinical Trials Statistical and Data Management Center, University of Iowa, Iowa City, Iowa, USA.
Dixon B KaufmanDivision of Transplantation, Department of Surgery, University of Wisconsin, Madison, Wisconsin, USA.
Olle KorsgrenDepartment of Immunology, Genetics and Pathology, Uppsala University, Uppsala, Sweden.
Christian P LarsenEmory Transplant Center, Emory University, Atlanta, Georgia, USA.
Xunrong LuoDepartment of Medicine, Duke University, Durham, North Carolina, USA.ORCID 0000-0001-5581-9409
Ali NajiDivision of Transplantation, Department of Surgery, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.
José OberholzerDepartment of Surgery, University of Illinois, Chicago, Illinois, USA.
Andrew M PosseltDepartment of Surgery, University of California, San Francisco, California, USA.
Camillo RicordiDiabetes Research Institute and Clinical Cell Transplant Program, University of Miami Miller School of Medicine, Miami, Florida, USA.
Peter A SeniorClinical Islet Transplant Program and Faculty of Medicine & Dentistry, University of Alberta, Edmonton, Alberta, Canada.
A M James ShapiroClinical Islet Transplant Program and Faculty of Medicine & Dentistry, University of Alberta, Edmonton, Alberta, Canada.
Peter G StockDepartment of Surgery, University of California, San Francisco, California, USA.ORCID 0000-0002-5806-0167
Nicole A TurgeonDepartment of Surgery, University of Texas Dell Medical School, Austin, Texas, USA.

Funding

WOMEN'S HEALTH IN CYSTIC FIBROSISM01RR000400 · UNIVERSITY OF MINNESOTA TWIN CITIES · 1985 to 2005
$19.6M
ZDV VS ZDV + DDL VS ZDV + DDL + NVP IN ASYMPTOMATIC HIV PATIENTSM01RR000040 · UNIVERSITY OF PENNSYLVANIA · 1985 to 2005
$19.2M
Clinical Islet Transplantation: Data Coordinating CenterU01DK070431 · UNIVERSITY OF IOWA · 2004 to 2004
$9.6M
Strategies to Improve Long Term Islet Graft SurvivalU01DK070460 · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · 2004 to 2005
$6.8M
Advancing Islet Transplants for Type 1 Diabetes CareU01AI065193 · UNIVERSITY OF MINNESOTA TWIN CITIES · 2004 to 2005
$6.8M
B-Lymphocyte Immunotherapy in Islet TransplantationU01DK070430 · UNIVERSITY OF PENNSYLVANIA · 2004 to 2005
$6.2M
Islet Transplant - Costimulatory Blockade with LEA29YU01AI065191 · UNIVERSITY OF ALBERTA · 2004 to 2005
$5.6M
Innate immunity in clinical islet transplantationU01AI065192 · UPPSALA UNIVERSITY · 2004 to 2005
$4.6M
Emory University U01AI089317Emory University UL1TR000454NCATS NIH HHS UL1 TR000003NCATS NIH HHS UL1 TR000004NCATS NIH HHS UL1 TR000050NCATS NIH HHS UL1 TR000114NCATS NIH HHS UL1 TR000150NCATS NIH HHS UL1 TR000454NCATS NIH HHS UL1 TR000460NCRR NIH HHS M01 RR000040NCRR NIH HHS M01 RR000400NCRR NIH HHS UL1 RR025741NIAID NIH HHS U01 AI065191NIAID NIH HHS U01 AI065192NIAID NIH HHS U01 AI065193NIAID NIH HHS U01 AI089316NIAID NIH HHS U01 AI089317NIDDK NIH HHS U01 DK070430NIDDK NIH HHS U01 DK070431NIDDK NIH HHS U01 DK070460NIDDK NIH HHS U01 DK085531Northwestern University U01AI089316Northwestern University UL1RR025741Northwestern University UL1TR000150University of Alberta U01AI065191University of California, San Francisco U01DK085531University of California, San Francisco UL1TR000004University of Illinois at Chicago 5U01DK070431University of Illinois at Chicago UL1TR000050University of Miami U01DK070460University of Miami UL1TR000460University of Minnesota M01-RR000400University of Minnesota U01AI065193University of Minnesota UL1TR000114University of Pennsylvania M01-RR00040University of Pennsylvania U01DK070430University of Pennsylvania UL1TR000003Uppsala Universitet U01AI065192
6 · The paper itself

Abstract

Allogeneic islet transplant offers a minimally invasive option for β cell replacement in the treatment of type 1 diabetes (T1D). The CIT consortium trial of purified human pancreatic islets (PHPI) in patients with T1D after kidney transplant (CIT06), a National Institutes of Health-sponsored phase 3, prospective, open-label, single-arm pivotal trial of PHPI, was conducted in 24 patients with impaired awareness of hypoglycemia while receiving intensive insulin therapy. PHPI were manufactured using standardized processes. PHPI transplantation was effective with 62.5% of patients achieving the primary endpoint of freedom from severe hypoglycemic events and HbA

Indexed as

Diabetes Mellitus, Type 1Islets of Langerhans TransplantationKidney TransplantationBlood GlucoseHumansInsulinProspective StudiesQuality of LifeBlood GlucoseInsulinbasic (laboratory) research/scienceclinical research/practicediabetesdiabetes: type 1islet transplantation

Identifiers

PMID32627352
PMCPMC9074710

What Socratic holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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 Socratic graph.