Evidence map›Paper›PMID 29233163›Full record

Trial reportJournal of orthopaedic surgery and research2017

Intra-articular injection of expanded autologous bone marrow mesenchymal cells in moderate and severe knee osteoarthritis is safe: a phase I/II study.

Mahasen Al-Najar, Hiba Khalil, Jihad Al-Ajlouni, Eman Al-Antary, Mohammad Hamdan, Reem Rahmeh, Dana Alhattab, Osama Samara, Mohamad Yasin, Amenah Al Abdullah and 4 more

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

Trial report in Journal of orthopaedic surgery and research, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02118519 (Use of Mesenchymal Stem Cells for the Repair of Articular Cartilage Disorder of Knee Using Intra-articular Injection of Mesenchymal Cells Alone or Mesenchymal Cells With Platelet Lysate), which is not on this map. Cited by 71 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
71citing papers in PubMed, 3 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.

NCT02118519 phase2completednot on this map

Use of Mesenchymal Stem Cells for the Repair of Articular Cartilage Disorder of Knee Using Intra-articular Injection of Mesenchymal Cells Alone or Mesenchymal Cells With Platelet Lysate

TypeinterventionalSponsorUniversity of JordanRan2014 to 2015Enrolled13ConditionsArticular Cartilage Disorder of Knee, Osteoarthritis, KneeArmsAutologous Mesenchymal Stem Cells
3 · Its place in the literature

Who cites it

71 citing papers in PubMed, 3 syntheses or guidelines pooled it.

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

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

14 authors.

Mahasen Al-NajarDepartment of Radiology, School of Medicine, University of Jordan, Amman, Jordan.
Hiba KhalilDepartment of Hematology, Faculty of Medical Laboratory Sciences, Alneelain University, Khartoum, Sudan.
Jihad Al-AjlouniDepartment of Orthopedics, School of Medicine, University of Jordan, Amman, Jordan.
Eman Al-AntarySchool of Medicine, University of Jordan, Amman, Jordan.
Mohammad HamdanDepartment of Orthopedics, School of Medicine, University of Jordan, Amman, Jordan.
Reem RahmehCell Therapy Center, University of Jordan, Amman, Jordan.
Dana AlhattabCell Therapy Center, University of Jordan, Amman, Jordan.
Osama SamaraDepartment of Radiology, School of Medicine, University of Jordan, Amman, Jordan.
Mohamad YasinDepartment of Orthopedics, School of Medicine, University of Jordan, Amman, Jordan.
Amenah Al AbdullahDepartment of Radiology, School of Medicine, University of Jordan, Amman, Jordan.
Esraa Al-JabbariDepartment of Radiology, School of Medicine, University of Jordan, Amman, Jordan.
Dima HmaidDepartment of Radiology, School of Medicine, University of Jordan, Amman, Jordan.
Hanan JafarCell Therapy Center, University of Jordan, Amman, Jordan.
Abdalla AwidiCell Therapy Center, University of Jordan, Amman, Jordan. abdalla.awidi@gmail.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundKnee osteoarthritis (KOA) is a major health problem especially in the aging population. There is a need for safe treatment that restores the cartilage and reduces the symptoms. The use of stem cells is emerging as a possible option for the moderate and severe cases. This study aimed at testing the safety of autologous bone marrow mesenchymal stem cells (BM-MSCs) expanded in vitro when given intra-articularly to patients with stage II and III KOA. As a secondary end point, the study tested the ability of these cells to relieve symptoms and restore the knee cartilage in these patients as judged by normalized knee injury and Osteoarthritis Outcome Score (KOOS) and by magnetic resonance imaging (MRI).

methodsThirteen patients with a mean age of 50 years suffering from KOA stages II and III were given two doses of BM-MSCs 1 month apart totaling 61 × 10

resultsNo severe adverse events were reported up to 24 months follow-up. Normalized KOOS improved significantly. Mean knee cartilage thickness measured by MRI improved significantly.

conclusionBM-MSCs given intra-articularly are safe in knee osteoarthrosis. Despite the limited number of patients in this study, the procedure described significantly improved the KOOS and knee cartilage thickness, indicating that they may enhance the functional outcome as well as the structural component.

trial registrationClinicalTrials.gov, NCT02118519.

Indexed as

Severity of Illness IndexAdultCells, CulturedFemaleFollow-Up StudiesHumansInjections, Intra-ArticularMaleMesenchymal Stem CellsMesenchymal Stem Cell TransplantationMiddle AgedOsteoarthritis, KneeProspective StudiesTransplantation, AutologousBone marrowIntra-articular injectionKnee osteoarthritisKOOS scoreMesenchymal stem cells

Identifiers

PMID29233163
PMCPMC5727956

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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.