Evidence map›Paper›PMID 29142919›Full record

ArticleKidney international reports2016

Implantation of Autologous Selected Renal Cells in Diabetic Chronic Kidney Disease Stages 3 and 4-Clinical Experience of a "First in Human" Study.

Peter Stenvinkel, Jonas Wadström, Tim Bertram, Randal Detwiler, David Gerber, Torkel B Brismar, Pontus Blomberg, Torbjörn Lundgren

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Kidney international reports, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
0.4field-weighted citation impact, top 33% 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

9 citing papers in PubMed, 15 citations in OpenAlex.

  1. Review
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  4. Chronic Kidney Disease: Challenges in Translational Medicine.Methods in molecular biology (Clifton, N.J.) · 2023
    Review
  5. Article
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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

8 authors at 4 institutions in 3 countries.

Peter StenvinkelDivision of Renal Medicine, Department of Clinical Sciences, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.
Jonas WadströmDivision of Transplantation Surgery, Department of Clinical Sciences, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.
Tim BertramRegenMed (Cayman) Ltd., Grand Cayman, Cayman Islands.
Randal DetwilerDivision of Nephrology and Hypertension, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.
David GerberDivision of Abdominal Transplantation, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.
Torkel B BrismarDivision of Radiology, Department of Clinical Sciences, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.
Pontus BlombergVecura at Clinical Research Center, Karolinska University Hospital, Stockholm, Sweden.
Torbjörn LundgrenDivision of Transplantation Surgery, Department of Clinical Sciences, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.
Karolinska Institutet · SEUniversity of North Carolina at Chapel Hill · USKarolinska University Hospital · SEUniversity College of the Cayman Islands · KY

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionAnimal models of chronic kidney disease demonstrate that a redundant population of therapeutically bioactive selected renal cells (SRCs) can be delivered to the kidney through intraparenchymal injection and arrest disease progression. Direct injection of SRCs has been shown to attenuate nuclear factor-κB, which is known to drive tissue inflammation, as well as the transforming growth factor-β-mediated plasminogen activator inhibitor-1 response that drives tissue fibrosis.

methodsWe present experience from the first-in-human clinical study with SRCs. Seven male type 2 diabetic patients (63 ± 2 years of age) with chronic kidney disease stage 3 to 4 (estimated glomerular filtration rate 25 ± 2 ml/min) were recruited. After blood and urine sampling, iohexol clearance, magnetic resonance imaging, and renal scintigraphy, patients underwent ultrasound-guided renal biopsy. Two cores of renal tissue were shipped to the manufacturing plant for cell isolation, culture, and product preparation. Formulated SRCs were transported back to study sites (range 59-87 days after biopsy) for intracortical injection using a retroperitoneoscopic technique.

resultsLaparoscopically assisted implantation of SRCs was uneventful in all patients. However, postoperative complications were common and suggest that other techniques of SRC delivery should be used. Kidney volume, split function, and glomerular filtration rate did not change during 12 months of follow-up. An extended 24-month follow-up in 5 of the patients showed a decline in estimated glomerular filtration rate (cystatin C). DISCUSSION: Postoperative complications following retroperitoneoscopic implantation of SRC in the kidney cortex seem to be related to the surgical procedure rather than to injection of the cell product. No changes in renal function were observed during the original 12-month protocol. Beyond the first 12 months after cell implantation, individual renal function began to deteriorate during further follow-up.

Indexed as

autologous selected renal cellschronic kidney diseasediabetes mellitus

Identifiers

PMID29142919
PMCPMC5678666
OpenAlexW2489015708

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.