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ArticleInternational orthopaedics2016

A multi-center analysis of adverse events among two thousand, three hundred and seventy two adult patients undergoing adult autologous stem cell therapy for orthopaedic conditions.

Christopher J Centeno, Hasan Al-Sayegh, Michael D Freeman, Jay Smith, William D Murrell, Rostyslav Bubnov

Erratum issued 4 registry-linked trialsAbstract read
PubMed Publisher
In one paragraph

Article in International orthopaedics, 2016. 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 4 registered trials, which are not on this map. Cited by 63 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
63citing papers in PubMed, 7 pooled it
–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.

NCT03340818 nacompletednot on this mapstarted 2018, after this paper: background citation

Bone Marrow Concentrate Intradiscal Injection for Chronic Discogenic Low Back Pain: A Double-Blind, Placebo Controlled Trial

TypeinterventionalSponsorAPM Spine and Sports PhysiciansRan2018 to 2024Enrolled66ConditionsDiscogenic PainArmsBone Marrow Concentrate, Placebo
NCT03898388 naterminatednot on this mapstarted 2019, after this paper: background citation

A Prospective Analysis Correlating the Osteoarthritic Knee Microenvironment to Clinical Outcome After Treatment With Regenexx® SD Treatment: A Multi-Site Study

TypeinterventionalSponsorRegenexx, LLCRan2019 to 2022Enrolled47ConditionsKnee OsteoarthritisArmsBone Marrow Concentrate treatment
NCT03964129 naunknown statusnot on this mapstarted 2017, after this paper: background citation

Clinical Evaluation of Decellularized Nerve Allograft With Autologous Bone Marrow Aspirate Concentrate (BMAC) to Improve Peripheral Nerve Repair and Functional Outcomes

TypeinterventionalSponsorBrooke Army Medical CenterRan2017 to 2021Enrolled15ConditionsPeripheral Nerve Injury Upper LimbArmsAvance Nerve Graft with Autologous BMAC
NCT04990128 phase3not yet recruitingnot on this mapstarted 2026, after this paper: background citation

Randomized Trial on the Evaluation of the Effectiveness of One Single Bone Marrow Aspirate Hip Injection Versus Triamcinolone for Hip Osteoarthritis

TypeinterventionalSponsorThe Cleveland ClinicRan2026 to 2027Enrolled100ConditionsHip OsteoarthritisArmsAspire Needle + Emcyte PureBMC, Triamcinolone
3 · Its place in the literature

Who cites it

63 citing papers in PubMed, 7 syntheses or guidelines pooled it.

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  7. Adjuvant Biological Therapies in Chronic Leg Ulcers.International journal of molecular sciences · 2017
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  15. Adipose-derived and bone marrow aspirate concentrate injections for osteoarthritis: A scoping review.PM & R : the journal of injury, function, and rehabilitation · 2026
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3 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors.

Christopher J CentenoCenteno-Schultz Clinic, Regenerative Sciences, LLC, 403 Summit Blvd, Broomfield, CO, 80021, USA. Centenooffice@centenoschultz.com.
Hasan Al-SayeghBiostatistician at Boston Children's Hospital, 450 Brookline Avenue, D-155E, Boston, MA, 02215, USA.
Michael D FreemanDepartment of Psychiatry, Oregon Health and Science University School of Medicine, Portland, OR, USA.
Jay SmithMayo Clinic Rochester, 200 1st St SW, Rochester, MN, 55905, USA.
William D MurrellAmerican Musculoskeletal Wellness Institute, P.C, 6701 Democracy Boulevard Suite 300, Bethesda, Maryland, 20817, USA.
Rostyslav BubnovThe Centre of Ultrasound Diagnostics and Interventional Sonography, Clinical Hospital "Pheophania" of State Affairs Department, Zabolotny Street, 21, 03680, Kyiv, Ukraine.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe purpose of the present investigation is to report on detailed complications among a much larger group of 2372 orthopaedic patients treated with stem cell injections who were followed in a treatment registry for up to nine years.

methodsAll patients underwent an MSC-based, percutaneous injection treatment of an orthopaedic condition between December 2005 and September 2014 at one of 18 clinical facilities. Treated areas of the body included the knee, hip, ankle/foot, hand/wrist, elbow, shoulder, and spine. The patients were followed prospectively via enrollment in a treatment registry. Patients were followed prospectively at one, three, six and 12 months, and annually thereafter, using an electronic system, ClinCapture software.

resultsA total of 3012 procedures were performed on 2372 patients with follow-up period of 2.2 years. A total of 325 adverse events were reported. The majority were pain post-procedure (n = 93, 3.9 % of the study population) and pain due to progressive degenerative joint disease (n = 90, 3.8 % of the study population). Seven cases reported neoplasms, a lower rate than in the general population. The lowest rate of adverse events was observed among patients injected with BMC alone.

conclusionLowest rate of adverse events was among those patients receiving BMC injections alone, but the higher rate of AEs for BMC plus adipose and cultured cells was readily explained by the nature of the therapy or the longer follow-up. There was no clinical evidence to suggest that treatment with MSCs of any type in this study increased the risk of neoplasm.

Indexed as

OrthopedicsCells, CulturedHumansInjections, Intra-ArticularKnee JointMusculoskeletal DiseasesPainBone marrow concentrateComplicationsMesenchymal stem cellsPlatelet rich plasmaRegistrySide effects

Identifiers

What OpenQuestion holds

Textmetadata
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.