Evidence map›Paper›PMID 26537851›Full record

ArticleJournal of translational medicine2015

Safety of allogeneic bone marrow derived mesenchymal stromal cell therapy in renal transplant recipients: the neptune study.

Marlies E J Reinders, Geertje J Dreyer, Jonna R Bank, Helene Roelofs, Sebastiaan Heidt, Dave L Roelen, Maarten L Zandvliet, Volkert A L Huurman, Wim E Fibbe, Cees van Kooten and 3 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase I
In one paragraph

Article in Journal of translational medicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02387151 (Safety of Allogeneic Bone Marrow Derived Mesenchymal Stromal Cell Therapy in Renal Transplant Recipients), which is not on this map. Cited by 40 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 3 pooled it
4.0field-weighted citation impact, top 6% 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.

NCT02387151 phase1completednot on this map

Safety of Allogeneic Bone Marrow Derived Mesenchymal Stromal Cell Therapy in Renal Transplant Recipients

TypeinterventionalSponsorLeiden University Medical CenterRan2015 to 2018Enrolled10ConditionsRejection, Graft LossArmsmesenchymal stromal cells
3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 3 syntheses or guidelines pooled it, 67 citations in OpenAlex.

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  19. Cellular therapies in organ transplantation.Transplant international : official journal of the European Society for Organ Transplantation · 2021
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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

13 authors at 1 institution in 1 country.

Marlies E J ReindersDepartment of Nephrology, Leiden University Medical Center, Albinusdreef 2, 2300 RC, Leiden, The Netherlands. m.e.j.reinders@lumc.nl.
Geertje J DreyerDepartment of Nephrology, Leiden University Medical Center, Albinusdreef 2, 2300 RC, Leiden, The Netherlands. G.J.Dreyer@lumc.nl.
Jonna R BankDepartment of Nephrology, Leiden University Medical Center, Albinusdreef 2, 2300 RC, Leiden, The Netherlands. J.R.Bank@lumc.nl.
Helene RoelofsDepartment of Immuno-Haematology and Blood Transfusion, Leiden University Medical Center, Albinusdreef 2, 2300 RC, Leiden, The Netherlands. H.Roelofs@lumc.nl.
Sebastiaan HeidtDepartment of Immuno-Haematology and Blood Transfusion, Leiden University Medical Center, Albinusdreef 2, 2300 RC, Leiden, The Netherlands. S.Heidt@lumc.nl.
Dave L RoelenDepartment of Immuno-Haematology and Blood Transfusion, Leiden University Medical Center, Albinusdreef 2, 2300 RC, Leiden, The Netherlands. D.L.Roelen@lumc.nl.
Maarten L ZandvlietDepartment of Clinical Parmacy and Toxicology, Leiden University Medical Center, Albinusdreef 2, 2300 RC, Leiden, The Netherlands. M.L.Zandvliet@lumc.nl.
Volkert A L HuurmanDepartment of Surgery, Leiden University Medical Center, Albinusdreef 2, 2300 RC, Leiden, The Netherlands. V.A.L.Huurman@lumc.nl.
Wim E FibbeDepartment of Immuno-Haematology and Blood Transfusion, Leiden University Medical Center, Albinusdreef 2, 2300 RC, Leiden, The Netherlands. W.E.Fibbe@lumc.nl.
Cees van KootenDepartment of Nephrology, Leiden University Medical Center, Albinusdreef 2, 2300 RC, Leiden, The Netherlands. C.van_Kooten@lumc.nl.
Frans H J ClaasDepartment of Immuno-Haematology and Blood Transfusion, Leiden University Medical Center, Albinusdreef 2, 2300 RC, Leiden, The Netherlands. F.H.J.Claas@lumc.nl.
Ton J RabelinkDepartment of Nephrology, Leiden University Medical Center, Albinusdreef 2, 2300 RC, Leiden, The Netherlands. A.J.Rabelink@lumc.nl.
Johan W de FijterDepartment of Nephrology, Leiden University Medical Center, Albinusdreef 2, 2300 RC, Leiden, The Netherlands. J.W.de_Fijter@lumc.nl.
Leiden University Medical Center · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMesenchymal stromal cells (MSC) may serve as an attractive therapy in renal transplantation due to their immunosuppressive and reparative properties. While most studies have used autologous MSCs, allogeneic MSCs offer the advantage of immediate availability for clinical use. This is of major importance for indications where instant treatment is needed, for example allograft rejection or calcineurin inhibitor toxicity. Clinical studies using allogeneic MSCs are limited in number. Although these studies showed no adverse reactions, allogeneic MSCs could possibly elicit an anti-donor immune response, which may increase the incidence of rejection and impact the allograft survival in the long term. These safety issues should be addressed before further studies are planned with allogeneic MSCs in the solid organ transplant setting. METHODS/

design10 renal allograft recipients, 18-75 years old, will be included in this clinical phase Ib, open label, single center study. Patients will receive two doses of 1.5 × 10(6) per/kg body weight allogeneic bone marrow derived MSCs intravenously, at 25 and 26 weeks after transplantation, when immune suppression levels are reduced. The primary end point of this study is safety by assessing biopsy proven acute rejection (BPAR)/graft loss after MSC treatment. Secondary end points, all measured before and after MSC infusions, include: comparison of fibrosis in renal biopsy by quantitative Sirius Red scoring; de novo HLA antibody development and extensive immune monitoring; renal function measured by cGFR and iohexol clearance; CMV and BK infection and other opportunistic infections. DISCUSSION: This study will provide information on the safety of allogeneic MSC infusion and its effect on the incidence of BPAR/graft loss.

trial registrationNCT02387151.

Indexed as

Kidney TransplantationMesenchymal Stem Cell TransplantationAdolescentAdultAgedBiopsyBone Marrow CellsFemaleGraft RejectionGraft SurvivalHumansImmunosuppressive AgentsMaleMesenchymal Stem CellsMiddle AgedProspective StudiesImmunosuppressive Agents

Identifiers

PMID26537851
PMCPMC4632480
OpenAlexW2127722636

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.