Evidence map›Paper›PMID 38366909›Full record

ArticleStem cells translational medicine2024

A Phase I Dose-Escalation Clinical Trial to Assess the Safety and Efficacy of Umbilical Cord-Derived Mesenchymal Stromal Cells in Knee Osteoarthritis.

Jose Matas, Cynthia García, Daniela Poblete, Rolando Vernal, Alexander Ortloff, Noymar Luque-Campos, Yessia Hidalgo, Jimena Cuenca, Catalina Infante, Maria Ignacia Cadiz and 3 more

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase I
In one paragraph

Article in Stem cells translational medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 43 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 2 pooled it
18.0field-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.

NCT03810521 phase1unknown statusnot on this map

A Phase I Dose-escalation Trial to Assess Safety and Efficacy of Cellistem-OA in Patients With Knee Osteoarthritis (CLT-OA1)

TypeinterventionalSponsorUniversidad de los Andes, ChileRan2019 to 2019Enrolled24ConditionsOsteoarthritis, KneeArmsumbilical cord derived-mesenchymal stromal cells
NCT07313020 early_phase1enrolling by invitationnot on this mapstarted 2025, after this paper: background citation

A Visualization Clinical Study Using a Handheld MPI Imaging Device for Monitoring Mesenchymal Stromal Cells in Osteoarthritis Treatment

TypeinterventionalSponsorSoochow UniversityRan2025 to 2026Enrolled10ConditionsKnee Arthritis OsteoarthritisArmsHuman Umbilical Cord-derived Mesenchymal Stromal Cells (hUC-MSCs), Ferumoxytol (SPIO) Solution for Injection (Placebo)
3 · Its place in the literature

Who cites it

43 citing papers in PubMed, 2 syntheses or guidelines pooled it, 41 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

13 authors at 3 institutions in 1 country.

Jose MatasCentro de Terapia Celular, Clínica Universidad de los Andes, Santiago, Chile.
Cynthia GarcíaIMPACT, Center of Interventional Medicine for Precision and Advanced Cellular Therapy, Santiago, Chile.
Daniela PobletePeriodontal Biology Laboratory, Facultad de Odontología, Universidad de Chile, Santiago, Chile.
Rolando VernalPeriodontal Biology Laboratory, Facultad de Odontología, Universidad de Chile, Santiago, Chile.
Alexander OrtloffDepartamento de Ciencias Veterinarias y Salud Pública, Facultad de Recursos Naturales, Universidad Católica de Temuco, Temuco, Chile.
Noymar Luque-CamposIMPACT, Center of Interventional Medicine for Precision and Advanced Cellular Therapy, Santiago, Chile.
Yessia HidalgoIMPACT, Center of Interventional Medicine for Precision and Advanced Cellular Therapy, Santiago, Chile.
Jimena CuencaIMPACT, Center of Interventional Medicine for Precision and Advanced Cellular Therapy, Santiago, Chile.
Catalina InfanteCentro de Terapia Celular, Clínica Universidad de los Andes, Santiago, Chile.
Maria Ignacia CadizCentro de Investigación e Innovación Biomédica, Facultad de Medicina, Universidad de Los Andes, Santiago, Chile.
Maroun KhouryIMPACT, Center of Interventional Medicine for Precision and Advanced Cellular Therapy, Santiago, Chile.
Patricia Luz-CrawfordIMPACT, Center of Interventional Medicine for Precision and Advanced Cellular Therapy, Santiago, Chile.ORCID 0000-0003-0067-7743
Francisco EspinozaCentro de Terapia Celular, Clínica Universidad de los Andes, Santiago, Chile.
Universidad de Los Andes, Chile · CLUniversity of Chile · CLUniversidad Católica de Temuco · CL

Funding

Interventional Medicine for Precision and Advanced Cellular Therapy #FB210024
6 · The paper itself

Abstract

Osteoarthritis (OA) is the most common degenerative joint disease. Mesenchymal stromal cells (MSC) are promising cell-based therapy for OA. However, there is still a need for additional randomized, dose-dependent studies to determine the optimal dose and tissue source of MSC for improved clinical outcomes. Here, we performed a dose-dependant evaluation of umbilical cord (UC)-derived MSC (Celllistem) in a murine model and in knee OA patients. For the preclinical study, a classical dose (200.000 cells) and a lower dose (50.000 cells) of Cellistem were intra-articularly injected into the mice knee joints. The results showed a dose efficacy response effect of Cellistem associated with a decreased inflammatory and degenerative response according to the Pritzker OARSI score. Following the same approach, the dose-escalation phase I clinical trial design included 3 sequential cohorts: low-dose group (2 × 106 cells), medium-dose group (20 × 106), and high-dose group (80 × 106). All the doses were safe, and no serious adverse events were reported. Nonetheless, 100% of the patients injected with the high-dose experienced injection-related swelling in the knee joint. According to WOMAC total outcomes, patients treated with all doses reported significant improvements in pain and function compared with baseline after 3 and 6 months. However, the improvements were higher in patients treated with both medium and low dose as compared to high dose. Therefore, our data demonstrate that the intra-articular injection of different doses of Cellistem is both safe and efficient, making it an interesting therapeutic alternative to treat mild and symptomatic knee OA patients. Trial registration ClinicalTrials.gov NCT03810521.

Indexed as

Mesenchymal Stem CellsMesenchymal Stem Cell TransplantationOsteoarthritis, KneeAnimalsHumansInjections, Intra-ArticularMiceTreatment OutcomeUmbilical Corddose escalationmurine OA modelosteoarthritisphase I clinical trialumbilical-cord-derived mesenchymal stromal cells

Identifiers

PMID38366909
PMCPMC10940813
OpenAlexW4391901111

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.