Evidence map›Paper›PMID 23903014›Full record

Trial reportTransplantation2013

A randomized pilot study of donor stem cell infusion in living-related kidney transplant recipients receiving alemtuzumab.

Gaetano Ciancio, Junichiro Sageshima, Edip Akpinar, Jeffrey J Gaynor, Linda Chen, Alberto Zarak, Lois Hanson, Lissett Tueros, Giselle Guerra, Adela Mattiazzi and 4 more

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Transplantation, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.0field-weighted citation impact, top 26% 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.

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

7 citing papers in PubMed, 14 citations in OpenAlex.

  1. Renal transplantation using belatacept without maintenance steroids or calcineurin inhibitors.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2014
    Trial
  2. Article
  3. Review
  4. Review
  5. Article
  6. Hematopoietic stem cells and solid organ transplantation.Transplantation reviews (Orlando, Fla.) · 2016
    Review
  7. Re-engineering islet cell transplantation.Pharmacological research · 2015
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 1 institution in 1 country.

Gaetano Ciancio1 The Lillian Jean Kaplan Renal Transplant Center of the Division of Transplantation, Department of Surgery, University of Miami Leonard M. Miller School of Medicine, Miami, FL. 2 Division of Nephrology and Hypertension, Department of Medicine, University of Miami Leonard M. Miller School of Medicine, Miami, FL. 3 Diabetes Research Institute, University of Miami Leonard M. Miller School of Medicine, Miami, FL. 4 Address correspondence to: Dr. Gaetano Ciancio, 1801 NW 9th Avenue, Miami, FL 33136.
Junichiro Sageshima
Edip Akpinar
Jeffrey J Gaynor
Linda Chen
Alberto Zarak
Lois Hanson
Lissett Tueros
Giselle Guerra
Adela Mattiazzi
Warren Kupin
David Roth
Camillo Ricordi
George W Burke
University of Miami · US

Funding

IMMUNE TOLERANCE NETWORK-266015416-266015416N01AI015416 · NIAID · REGENTS OF THE UNIVERSITY OF C · PI BLUESTONE, JEFFREY A · 2002 to 2006
–
NIAID NIH HHS N01 AI015416
6 · The paper itself

Abstract

backgroundTransplant tolerance would remove the need for maintenance immunosuppression while improving survival and quality of life.

methodsA prospective, randomized pilot study was undertaken to assess the safety and efficacy of donor stem cell infusion (DSCI) in living-related kidney transplant recipients treated with alemtuzumab (C1H) induction and tacrolimus and mycophenolate maintenance with switch to sirolimus and weaning over 2 years.

resultsFour patients received DSCI; five patients were controls. Graft failure occurred in two patients in the DSCI arm. Recurrence of glomerular disease occurred in two DSCI recipients, leading to graft loss in one. Biopsy-proven acute rejection episodes occurred in three patients (two in the DSCI vs. one in the control). One DSCI patient, with recurrence, subsequently developed antibody-mediated rejection leading to graft failure. In the remaining two DSCI patients, weaning was attempted but was not successful. All (4 of 4) DSCI patients had biopsy-proven chronic allograft injury and/or recurrence.

conclusionDSCI with C1H induction and a steroid-free maintenance regimen in a small group of patients failed to induce tolerance, with suboptimal patient and graft survival. The results do not justify extension of this particular trial and underscore the importance of patient selection, specifically avoidance of patients with glomerulopathies whose recurrence may obscure potential benefit.

Indexed as

FamilyKidney TransplantationLiving DonorsStem Cell TransplantationAdultAlemtuzumabAntibodies, Monoclonal, HumanizedDrug SubstitutionFemaleFloridaGraft RejectionGraft SurvivalHumansImmunosuppressive AgentsMaleMiddle AgedAlemtuzumabAntibodies, Monoclonal, HumanizedImmunosuppressive AgentsMycophenolic AcidSirolimusTacrolimus

Identifiers

PMID23903014
PMCPMC3818358
OpenAlexW2026327645

What OpenQuestion holds

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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 OpenQuestion graph.