Evidence map›Paper›PMID 33036661›Full record

ArticleTrials2020

Efficacy of one-stage cartilage repair using allogeneic mesenchymal stromal cells and autologous chondron transplantation (IMPACT) compared to nonsurgical treatment for focal articular cartilage lesions of the knee: study protocol for a crossover randomized controlled trial.

J V Korpershoek, L A Vonk, E C Kester, L B Creemers, T S de Windt, M M A Kip, D B F Saris, R J H Custers

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04236739 (Randomized Controlled Trial Comparing Clinical Outcomes of Instant MSC Product Accompanying Autologous Chondron Transplantation), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
2.3field-weighted citation impact, top 11% 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.

NCT04236739 phase3completednot on this map

Randomized Controlled Trial Comparing Clinical Outcomes of Instant MSC Product Accompanying Autologous Chondron Transplantation (IMPACT) for Focal Articular Cartilage Lesions of the Knee to Conservative Treatment

TypeinterventionalSponsorR.J.H. CustersRan2019 to 2025Enrolled60ConditionsCartilage DamageArmsInstant MSC Product accompanying Autologous Chondron Transplantation
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 22 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Article
  5. Review
  6. Review
  7. Article
  8. Cell therapy for cartilage repair.Emerging topics in life sciences · 2021
    Review
  9. 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

8 authors at 3 institutions in 3 countries.

J V KorpershoekDepartment of Orthopaedics, University Medical Center Utrecht, Heidelberglaan 100, 3584CX, Utrecht, The Netherlands.
L A VonkDepartment of Orthopaedics, University Medical Center Utrecht, Heidelberglaan 100, 3584CX, Utrecht, The Netherlands.
E C KesterDepartment of Orthopaedics, University Medical Center Utrecht, Heidelberglaan 100, 3584CX, Utrecht, The Netherlands.
L B CreemersDepartment of Orthopaedics, University Medical Center Utrecht, Heidelberglaan 100, 3584CX, Utrecht, The Netherlands.
T S de WindtDepartment of Orthopaedics, University Medical Center Utrecht, Heidelberglaan 100, 3584CX, Utrecht, The Netherlands.
M M A KipDepartment of Health Technology and Services Research, Technical Medical Centre, University of Twente, Technohal, Hallenweg 5, 7522, NH, Enschede, The Netherlands.
D B F SarisDepartment of Orthopaedics, University Medical Center Utrecht, Heidelberglaan 100, 3584CX, Utrecht, The Netherlands.
R J H CustersDepartment of Orthopaedics, University Medical Center Utrecht, Heidelberglaan 100, 3584CX, Utrecht, The Netherlands. r.j.h.custers@umcutrecht.nl.ORCID http://orcid.org/0000-0001-5253-2883
Heidelberg University · DEMayo Clinic · USUniversity of Twente · NL

Funding

ZonMw 11600.4103ZonMw 116004103
6 · The paper itself

Abstract

backgroundArticular cartilage defects in the knee have poor intrinsic healing capacity and may lead to functional disability and osteoarthritis (OA). "Instant MSC Product accompanying Autologous Chondron Transplantation" (IMPACT) combines rapidly isolated recycled autologous chondrons with allogeneic MSCs in a one-stage surgery. IMPACT was successfully executed in a first-in-man investigator-driven phase I/II clinical trial in 35 patients. The purpose of this study is to compare the efficacy of IMPACT to nonsurgical treatment for the treatment of large (2-8 cm

methodsSixty patients will be randomized to receive nonsurgical care or IMPACT. After 9 months of nonsurgical care, patients in the control group are allowed to receive IMPACT surgery. The Knee Injury and Osteoarthritis Outcome Score (KOOS), pain (numeric rating scale, NRS), and EuroQol five dimensions five levels (EQ5D-5 L) will be used to compare outcomes at baseline and 3, 6, 9, 12, and 18 months after inclusion. Cartilage formation will be assessed at baseline, and 6 and 18 months after inclusion using MRI. An independent rheumatologist will monitor the onset of a potential inflammatory response. (Severe) adverse events will be recorded. Lastly, the difference between IMPACT and nonsurgical care in terms of societal costs will be assessed by monitoring healthcare resource use and productivity losses during the study period. A health economic model will be developed to estimate the incremental cost-effectiveness ratio of IMPACT vs. nonsurgical treatment in terms of costs per quality adjusted life year over a 5-year time horizon. DISCUSSION: This study is designed to evaluate the efficacy of IMPACT compared to nonsurgical care. Additionally, safety of IMPACT will be assessed in 30 to 60 patients. Lastly, this study will evaluate the cost-effectiveness of IMPACT compared to nonsurgical care.

trial registrationNL67161.000.18 [Registry ID: CCMO] 2018#003470#27 [EU-CTR; registered on 26 March 2019] NCT04236739 [ ClinicalTrials.gov ] [registered after start of inclusion; 22 January 2020].

Indexed as

Cartilage, ArticularHematopoietic Stem Cell TransplantationMesenchymal Stem CellsMesenchymal Stem Cell TransplantationOsteoarthritis, KneeChondrocytesHumansKnee JointRandomized Controlled Trials as TopicTransplantation, AutologousTreatment OutcomeAdvanced therapy medicinal product (ATMP)Articular cartilage defectChondrocytesChondronsCrossover designKneeMesenchymal stromal cells (MSC)Randomized controlled trial (RCT)Surgery

Identifiers

PMID33036661
PMCPMC7547426
OpenAlexW3092012358

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.