Evidence map›Paper›PMID 32238172›Full record

Trial reportJournal of orthopaedic surgery and research2020

Safety and efficacy of treating symptomatic, partial-thickness rotator cuff tears with fresh, uncultured, unmodified, autologous adipose-derived regenerative cells (UA-ADRCs) isolated at the point of care: a prospective, randomized, controlled first-in-human pilot study.

Jason L Hurd, Tiffany R Facile, Jennifer Weiss, Matthew Hayes, Meredith Hayes, John P Furia, Nicola Maffulli, Glenn E Winnier, Christopher Alt, Christoph Schmitz and 2 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of orthopaedic surgery and research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02918136 (Safety and Efficacy of Adult Adipose-Derived Stem Cell Injections Into Partial Thickness Rotator Cuff Tears), which is not on this map. Cited by 39 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 2 pooled it
9.0field-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.

NCT02918136 nacompletednot on this map

Safety and Efficacy of Adult Adipose-Derived Stem Cell Injections Into Partial Thickness Rotator Cuff Tears

TypeinterventionalSponsorInGeneron, Inc.Ran2016 to 2018Enrolled18ConditionsRotator Cuff Tear - Partial ThicknessArmsAdipose derived regenerative cells, Cortisone Injectable
3 · Its place in the literature

Who cites it

39 citing papers in PubMed, 2 syntheses or guidelines pooled it, 81 citations in OpenAlex.

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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

12 authors at 4 institutions in 4 countries.

Jason L HurdSanford Orthopedics & Sports Medicine Sioux Falls, 1210 W. 18th St., Suite G01, Sioux Falls, SD, 57104, USA. Jason.Hurd@SanfordHealth.org.
Tiffany R FacileSanford Health, Sioux Falls, SD, USA.
Jennifer WeissSanford Health, Sioux Falls, SD, USA.
Matthew HayesSanford Radiology Clinic, Sioux Falls, SD, USA.
Meredith HayesSanford Radiology Clinic, Sioux Falls, SD, USA.
John P FuriaSUN Orthopedics of Evangelical Community Hospital, Lewisburg, PA, USA.
Nicola MaffulliDepartment of Musculoskeletal Disorders, Faculty of Medicine and Surgery, University of Salerno, Salerno, Italy.
Glenn E WinnierInGeneron, Inc., Houston, TX, USA.
Christopher AltInGeneron GmbH, Munich, Germany.
Christoph SchmitzInstitute of Anatomy, Faculty of Medicine, LMU Munich, Munich, Germany.
Eckhard U AltSanford Health, Sioux Falls, SD, USA.
Mark LundeenSanford Orthopedics & Sports Medicine Fargo, Fargo, ND, USA.
Sanford Health · USCommunity Hospital · USLudwig-Maximilians-Universität München · DEQueen Mary University of London · GB

Funding

InGeneron, Inc. N/ASanford Health N/A
6 · The paper itself

Abstract

backgroundThis study tested the hypothesis that treatment of symptomatic, partial-thickness rotator cuff tears (sPTRCT) with fresh, uncultured, unmodified, autologous adipose-derived regenerative cells (UA-ADRCs) isolated from lipoaspirate at the point of care is safe and more effective than corticosteroid injection.

methodsSubjects aged between 30 and 75 years with sPTRCT who did not respond to physical therapy treatments for at least 6 weeks were randomly assigned to receive a single injection of an average 11.4 × 10

resultsNo severe adverse events related to the injection of UA-ADRCs were observed in the 12 months post treatment. The risks connected with treatment of sPTRCT with UA-ADRCs were not greater than those connected with treatment of sPTRCT with corticosteroid injection. However, one subject in the corticosteroid group developed a full rotator cuff tear during the course of this pilot study. Despite the small number of subjects in this pilot study, those in the UA-ADRCs group showed statistically significantly higher mean ASES total scores at W24 and W52 post treatment than those in the corticosteroid group (p < 0.05). DISCUSSION: This pilot study suggests that the use of UA-ADRCs in subjects with sPTRCT is safe and leads to improved shoulder function without adverse effects. To verify the results of this initial safety and feasibility pilot study in a larger patient population, a randomized controlled trial on 246 patients suffering from sPTRCT is currently ongoing.

trial registrationClinicaltrials.gov ID NCT02918136. Registered September 28, 2016, https://clinicaltrials.gov/ct2/show/NCT02918136. LEVEL OF EVIDENCE: Level I; prospective, randomized, controlled trial.

Indexed as

Point-of-Care SystemsAdipose TissueAdultAgedFemaleFollow-Up StudiesHumansMaleMiddle AgedPilot ProjectsProspective StudiesRegenerationRotator Cuff InjuriesSingle-Blind MethodStem Cell TransplantationTransplantation, AutologousAdipose-derived regenerative cells (ADRCs)Partial rotator cuff tearPoint of care treatmentSafetyShoulder diseaseStem cellsStromal vascular fraction

Identifiers

PMID32238172
PMCPMC7110715
OpenAlexW2997300280

What OpenQuestion holds

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LicenceCC BY
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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.