Evidence map›Paper›PMID 40425577›Full record

Trial reportNature communications2025

On-chip 3D potency assay for prediction of clinical outcomes for cell therapy candidates for osteoarthritis.

Rebecca S Schneider, Elisa B Nieves, Bhavay Aggarwal, Annie C Bowles-Welch, Hazel Y Stevens, Linda E Kippner, Scott D Boden, Kenneth Mautner, Hicham Drissi, Krishnendu Roy and 3 more

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Nature communications, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03818737 (Randomized Multicenter Phase 3 Single-blind Trial Comparing the Efficacy of Corticosteroid Control to Mesenchymal Stem Cell Preparations From Autologous Bone Marrow Concentrate), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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.

NCT03818737 phase3completednot on this map

Randomized Multicenter Phase 3 Single-blind Trial Comparing the Efficacy of Corticosteroid Control to Mesenchymal Stem Cell Preparations From Autologous Bone Marrow Concentrate (BMAC), Adipose-derived Stem Cells in the Form of Stromal Vascular Fraction (SVF), and Third-party Human Mesenchymal Stem Cells Manufactured From Umbilical Cord Tissue for the Treatment of Unilateral Knee Osteoarthritis (OA)

TypeinterventionalSponsorEmory UniversityRan2019 to 2022Enrolled475ConditionsOsteoarthritisArmsBone Marrow Derived MSCs, Adipose-derived MSCs, Umbilical Cord Tissue (UCT) MSCs, Corticosteroid injection
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Article
  2. Review
  3. Review
  4. Review
  5. 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

13 authors.

Rebecca S SchneiderSchool of Chemical and Biomolecular Engineering, Georgia Institute of Technology, Atlanta, GA, USA.
Elisa B NievesPetit Institute for Bioengineering and Bioscience, Georgia Institute of Technology, Atlanta, GA, USA.
Bhavay AggarwalCoulter Department of Biomedical Engineering, Georgia Institute of Technology and Emory University, Atlanta, GA, USA.
Annie C Bowles-WelchPetit Institute for Bioengineering and Bioscience, Georgia Institute of Technology, Atlanta, GA, USA.ORCID http://orcid.org/0000-0003-1924-8949
Hazel Y StevensPetit Institute for Bioengineering and Bioscience, Georgia Institute of Technology, Atlanta, GA, USA.
Linda E KippnerPetit Institute for Bioengineering and Bioscience, Georgia Institute of Technology, Atlanta, GA, USA.ORCID http://orcid.org/0000-0003-0263-0279
Scott D BodenDepartment of Orthopaedics, Emory University, Atlanta, GA, USA.
Kenneth MautnerDepartment of Orthopaedics, Emory University, Atlanta, GA, USA.
Hicham DrissiDepartment of Orthopaedics, Emory University, Atlanta, GA, USA.
Krishnendu RoyPetit Institute for Bioengineering and Bioscience, Georgia Institute of Technology, Atlanta, GA, USA.ORCID http://orcid.org/0000-0002-9972-0950
Wilbur A LamPetit Institute for Bioengineering and Bioscience, Georgia Institute of Technology, Atlanta, GA, USA.ORCID http://orcid.org/0000-0002-0325-7990
Saurabh SinhaCoulter Department of Biomedical Engineering, Georgia Institute of Technology and Emory University, Atlanta, GA, USA.ORCID http://orcid.org/0000-0001-6033-7746
Andrés J GarcíaPetit Institute for Bioengineering and Bioscience, Georgia Institute of Technology, Atlanta, GA, USA. andres.garcia@me.gatech.edu.ORCID http://orcid.org/0000-0001-6602-2518

Funding

Hydrogels for hMSC delivery & engraftmentR01AR062368 · NIAMS · GEORGIA INSTITUTE OF TECHNOLOGY · PI GARCIA, ANDRES J · 2012 to 2022
$3.5M
NIAMS NIH HHS R01 AR062368
6 · The paper itself

Abstract

The lack of clinically predictive potency assays for cell products significantly impedes translation of these therapies. Here, we describe a microfluidic on-chip 3D system for rapid evaluation of a subset of patient-derived bone marrow aspirate concentrate (BMAC) samples used in a phase 3 multicenter trial (NCT03818737) evaluating autologous cells for relieving knee osteoarthritis pain. BMAC clinical samples cultured in the on-chip 3D system exhibit elevated levels of immunomodulatory and trophic proteins compared to 2D culture. Using analyte information from in vitro assays and patient-matched clinical data, we build linear regression prediction models for clinical outcomes. We demonstrate improved clinical prediction by cross-validation accuracy for the on-chip 3D platform compared to 2D culture. Additionally, on-chip 3D assay metrics display higher correlative power with patient pain scores compared to the 2D assay. This study establishes a potency assay with improved prediction power to accelerate translation of cell therapies.

Indexed as

Cell- and Tissue-Based TherapyLab-On-A-Chip DevicesOsteoarthritisOsteoarthritis, KneeAgedBone Marrow CellsFemaleHumansMaleMiddle AgedTreatment Outcome

Identifiers

PMID40425577
PMCPMC12116846

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.