Evidence map›Paper›PMID 40281581›Full record

ArticleBMC musculoskeletal disorders2025

Effectiveness and safety of multiple injections of human placenta-derived MSCs for knee osteoarthritis: a nonrandomized phase I trial.

Yevhen Holiuk, Roman Birsa, Tetiana Bukreieva, Petro Nemtinov, Vitalii Kyryk, Alina Ustymenko, Vadym Mazevych, Mykola Sokolov, Galyna Lobyntseva, Volodymyr Shablii

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

Article in BMC musculoskeletal disorders, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04453111 (Efficacy of Bone-marrow-derived and Placenta-derived Multipotent Mesenchymal Stem / Stromal Cells for Osteoarthritis), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 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.

NCT04453111 phase1 / phase2unknown statusnot on this map

Efficacy of Bone-marrow-derived and Placenta-derived Multipotent Mesenchymal Stem / Stromal Cells for Osteoarthritis

TypeinterventionalSponsorInstitute of Cell TherapyRan2020 to 2021Enrolled45ConditionsKnee OsteoarthritisArmsPlacenta-derived MMSCs, Bone marrow-derived MMSCs, Hyalgan 20 mg in 2 ML Prefilled Syringe
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Review
  4. Review
  5. 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

10 authors.

Yevhen HoliukState Institution "The Institute of Traumatology and Orthopedics by NAMS of Ukraine", 27 Bulvarno-Kudriavska Street, Kyiv, 01601, Ukraine.
Roman BirsaDepartment of Traumatology, Kyiv City Clinical Hospital, #6, 3 Guzara Ave, Kyiv, 03680, Ukraine.
Tetiana BukreievaLaboratory of Biosynthesis of Nucleic Acids, Institute of Molecular Biology and Genetics of National Academy of Science of Ukraine, 150 Zabolotnogo Str, Kyiv, 03143, Ukraine.
Petro NemtinovInstitute of Cell Therapy, 9 Mokra str, Kyiv, 03035, Ukraine.
Vitalii KyrykCell and Tissue Technologies Department, M. D. Strazhesko National Scientific Center of Cardiology, Clinical and Regenerative Medicine of the National Academy of Medical Sciences of Ukraine, 5 Svyatoslav Khorobrygo str, Kyiv, 03151, Ukraine.
Alina UstymenkoCell and Tissue Technologies Department, M. D. Strazhesko National Scientific Center of Cardiology, Clinical and Regenerative Medicine of the National Academy of Medical Sciences of Ukraine, 5 Svyatoslav Khorobrygo str, Kyiv, 03151, Ukraine.
Vadym MazevychState Institution "The Institute of Traumatology and Orthopedics by NAMS of Ukraine", 27 Bulvarno-Kudriavska Street, Kyiv, 01601, Ukraine.
Mykola SokolovInstitute of Cell Therapy, 9 Mokra str, Kyiv, 03035, Ukraine.
Galyna LobyntsevaInstitute of Cell Therapy, 9 Mokra str, Kyiv, 03035, Ukraine.
Volodymyr ShabliiPlacenta Stem Cell Laboratory, Institute of Cell Therapy, 9 Mokra str, Cryobank, Kyiv, 03035, Ukraine. shablii2301@gmail.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThis study investigates the safety and efficacy of three intra-articular (IA) injections of cryopreserved human placenta-derived mesenchymal stem cells (hP-MSCs) for knee osteoarthritis (KOA) over a 1-year follow-up period.

methodsA total of 26 patients with stage II-III KOA were enrolled in this non-randomized, open-label study. Patients received either conventional therapy with hyaluronic acid (HA) alone (Control group, n = 11) or in combination with hP-MSCs (MSC group, n = 15) via three intra-articular injections with 4-week intervals. Clinical outcomes were assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Visual Analogue Scale (VAS), and magnetic resonance imaging (MRI) at 6 and 12 months following the first injection. Blood samples were analyzed for cytokine levels.

resultsThree injections of hP-MSCs combined with HA were well-tolerated, with no severe adverse events observed. Significant improvements in WOMAC and VAS scores were noted in the MSC group compared to the Control group at both 6 and 12 months. MRI analysis revealed no significant differences in cartilage thickness or optical density index between the groups. Additionally, serum cytokine analysis showed a significant decrease in interleukin-2 (IL-2) levels in the MSC group, indicating an anti-inflammatory effect of hP-MSCs. However, no significant changes were observed in other cytokines.

conclusionThis study demonstrates that three intra-articular injections of cryopreserved hP-MSCs in combination with HA are safe and effective for treating KOA, providing sustained clinical improvement at the 1-year follow-up.

trial registrationNCT04453111, #7/09.26.2018. Registered 02 January 2020, https://www. CLINICALTRIALS: gov/study/NCT04453111 .

Indexed as

Mesenchymal Stem Cell TransplantationOsteoarthritis, KneePlacentaAdultAgedFemaleFollow-Up StudiesHumansHyaluronic AcidInjections, Intra-ArticularMagnetic Resonance ImagingMaleMiddle AgedPregnancyTreatment OutcomeHyaluronic AcidHuman placenta-derived mesenchymal stem cellsHyaluronic acidInflammationKnee osteoarthritisMSCsVASWOMAC

Identifiers

PMID40281581
PMCPMC12032682

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.