Evidence map›Paper›PMID 37919438›Full record

Trial reportNature medicine2023

Cell-based versus corticosteroid injections for knee pain in osteoarthritis: a randomized phase 3 trial.

Ken Mautner, Michael Gottschalk, Scott D Boden, Alison Akard, Won C Bae, Lora Black, Blake Boggess, Paramita Chatterjee, Christine B Chung, Kirk A Easley and 12 more

Erratum issued Registry-linked trialOpen access · hybridAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase II
In one paragraph

Trial report in Nature medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. 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 74 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
74citing papers in PubMed, 5 pooled it
23.6field-weighted citation impact, top 1% 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.

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

74 citing papers in PubMed, 5 syntheses or guidelines pooled it, 95 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
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  6. Trial
  7. SPOT: An Early Detection Tool for Predicting Pain Trajectories Following Intra-Articular Injections.Journal of orthopaedic research : official publication of the Orthopaedic Research Society · 2026
    Trial
  8. Trial
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  11. Review
  12. Review
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  19. Adipose-derived and bone marrow aspirate concentrate injections for osteoarthritis: A scoping review.PM & R : the journal of injury, function, and rehabilitation · 2026
    Article
  20. Review

14 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

22 authors at 7 institutions in 1 country.

Ken Mautner *Department of Orthopaedics, Emory University, Atlanta, GA, USA. kmautne@emory.edu.ORCID 0000-0001-8458-0126
Michael Gottschalk *Department of Orthopaedics, Emory University, Atlanta, GA, USA.
Scott D BodenDepartment of Orthopaedics, Emory University, Atlanta, GA, USA.
Alison AkardDepartment of Orthopaedics, Emory University, Atlanta, GA, USA.
Won C BaeDepartment of Radiology, University of California, Davis, La Jolla, CA, USA.
Lora BlackSanford Health, Sioux Falls, SD, USA.
Blake BoggessDuke Sports Medicine, Durham, NC, USA.
Paramita ChatterjeeMarcus Center for Therapeutic Cell Characterization and Manufacturing, Georgia Institute of Technology, Atlanta, GA, USA.ORCID 0000-0001-9761-2289
Christine B ChungDepartment of Radiology, University of California, Davis, La Jolla, CA, USA.
Kirk A EasleyDepartment of Biostatistics and Bioinformatics, Emory University, Atlanta, GA, USA.ORCID 0000-0003-4419-2617
Greg GibsonCenter for Integrative Genomics, Georgia Institute of Technology, Atlanta, GA, USA.ORCID 0000-0002-5352-5877
Josh HackelAndrews Institute, Gulf Breeze, AL, USA.
Katie JensenSanford Health, Sioux Falls, SD, USA.
Linda KippnerMarcus Center for Therapeutic Cell Characterization and Manufacturing, Georgia Institute of Technology, Atlanta, GA, USA.ORCID 0000-0003-0263-0279
Chad KurtenbachSanford Health, Sioux Falls, SD, USA.
Joanne KurtzbergMarcus Center for Therapeutic Cures, Duke University, Durham, NC, USA.
R Amadeus MasonDepartment of Orthopaedics, Emory University, Atlanta, GA, USA.
Benjamin NoonanSanford Health, Fargo, ND, USA.
Krishnendu RoyBiomedical Engineering, Vanderbilt University, Nashville, TN, USA.
Verle ValentineSanford Health, Sioux Falls, SD, USA.
Carolyn YeagoMarcus Center for Therapeutic Cell Characterization and Manufacturing, Georgia Institute of Technology, Atlanta, GA, USA.
Hicham DrissiDepartment of Orthopaedics, Emory University, Atlanta, GA, USA. hicham.drissi@emory.edu.
Emory University · USSanford Health · USGeorgia Institute of Technology · USUniversity of California, Davis · USAndrews Institute for Orthopaedics & Sports Medicine · USDuke University · USVanderbilt University · US

Funding

Billi and Bernie Marcus Foundation 2422
6 · The paper itself

Abstract

Various types of cellular injection have become a popular and costly treatment option for patients with knee osteoarthritis despite a paucity of literature establishing relative efficacy to each other or corticosteroid injections. Here we aimed to identify the safety and efficacy of cell injections from autologous bone marrow aspirate concentrate, autologous adipose stromal vascular fraction and allogeneic human umbilical cord tissue-derived mesenchymal stromal cells, in comparison to corticosteroid injection (CSI). The study was a phase 2/3, four-arm parallel, multicenter, single-blind, randomized, controlled clinical trial with 480 patients with a diagnosis of knee osteoarthritis (Kellgren-Lawrence II-IV). Participants were randomized to the three different arms with a 3:1 distribution. Arm 1: autologous bone marrow aspirate concentrate (n = 120), CSI (n = 40); arm 2: umbilical cord tissue-derived mesenchymal stromal cells (n = 120), CSI (n = 40); arm 3: stromal vascular fraction (n = 120), CSI (n = 40). The co-primary endpoints were the visual analog scale pain score and Knee injury and Osteoarthritis Outcome Score pain score at 12 months versus baseline. Analyses of our primary endpoints, with 440 patients, revealed that at 1 year post injection, none of the three orthobiologic injections was superior to another, or to the CSI control. In addition, none of the four groups showed a significant change in magnetic resonance imaging osteoarthritis score compared to baseline. No procedure-related serious adverse events were reported during the study period. In summary, this study shows that at 1 year post injection, there was no superior orthobiologic as compared to CSI for knee osteoarthritis. ClinicalTrials.gov Identifier: NCT03818737.

Indexed as

Osteoarthritis, KneeHumansPainSingle-Blind MethodTreatment Outcome

Identifiers

PMID37919438
PMCPMC10719084
OpenAlexW4388216934

What OpenQuestion holds

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LicenceCC BY
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.