Evidence map›Paper›PMID 30197978›Full record

ArticleKidney international reports2018

Extracorporeal Stromal Cell Therapy for Subjects With Dialysis-Dependent Acute Kidney Injury.

Brian L K Miller, Payal Garg, Ben Bronstein, Elizabeth LaPointe, Herb Lin, David M Charytan, Arno W Tilles, Biju Parekkadan

Abstract read
In one paragraph

Article in Kidney international reports, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing 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

8 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Opportunities for biomaterials to address the challenges of COVID-19.Journal of biomedical materials research. Part A · 2020
    Review
  5. Kidney regeneration approaches for translation.World journal of urology · 2020
    Review
  6. Growing a new human kidney.Kidney international · 2019
    Review
  7. Review
  8. Mesenchymal Stem Cells-Potential Applications in Kidney Diseases.International journal of molecular sciences · 2019
    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

8 authors.

Brian L K MillerSentien Biotechnologies, Inc., Lexington, Massachusetts, USA.
Payal GargSentien Biotechnologies, Inc., Lexington, Massachusetts, USA.
Ben BronsteinCold Spring Venture Advisors, LLC, Watertown, Massachusetts, USA.
Elizabeth LaPointeEndPointe Clinical Resources, Inc., Hollis, New Hampshire, USA.
Herb LinDepartment of Nephrology, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.
David M CharytanDepartment of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Arno W TillesSentien Biotechnologies, Inc., Lexington, Massachusetts, USA.
Biju ParekkadanSentien Biotechnologies, Inc., Lexington, Massachusetts, USA.

Funding

Transforming Dialysis into a Controlled Drug Delivery System for Stem Cell DeriveR44DK085766 · NIDDK · SENTIEN BIOTECHNOLOGIES, INC. · PI CHARYTAN, DAVID M, TILLES, ARNO W · 2012 to 2016
$3.8M
Stem Cell Bioreactor for Cardiac CareR44HL128659 · NHLBI · SENTIEN BIOTECHNOLOGIES, INC. · PI TILLES, ARNO W · 2015 to 2017
$1.8M
NHLBI NIH HHS R44 HL128659NIDDK NIH HHS R44 DK085766
6 · The paper itself

Abstract

introductionThe pathophysiology of acute kidney injury (AKI) involves damage to renal epithelial cells, podocytes, and vascular beds that manifests into a deranged, self-perpetuating immune response and peripheral organ dysfunction. Such an injury pattern requires a multifaceted therapeutic to alter the wound healing response systemically. Mesenchymal stromal cells (MSCs) are a unique source of secreted factors that can modulate an inflammatory response to acute organ injury and enhance the repair of injured tissue at the parenchymal and endothelial levels. This phase Ib/IIa clinical trial evaluates SBI-101, a combination product that administers MSCs extracorporeally to overcome pharmacokinetic barriers of MSC transplantation. SBI-101 contains allogeneic human MSCs inoculated into a hollow-fiber hemofilter for the treatment of patients with severe AKI who are receiving continuous renal replacement therapy (CRRT). SBI-101 therapy is designed to reprogram the molecular and cellular components of blood in patients with severe organ injury.

methodsThis study is a prospective, multicenter, randomized, double-blind, sham-controlled, study of subjects with a clinical diagnosis of AKI who are receiving CRRT. Up to 32 subjects may be enrolled to provide 24 evaluable subjects (as a per protocol population). Subjects will receive CRRT in tandem with a sham control (0 MSCs), or the low- (250 × 10

resultsThe study will measure dose-dependent safety, renal efficacy, and exploratory biomarkers to characterize the pharmacokinetics and pharmacodynamics of SBI-101 in treated subjects.

conclusionThis first-in-human clinical trial will evaluate the safety and tolerability of SBI-101 in patients with AKI who require CRRT.

Indexed as

bioreactorcritical careex vivomesenchymal stem cell

Identifiers

PMID30197978
PMCPMC6127415

What OpenQuestion holds

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Registered trials

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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.