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Osteoarthritis, KneeNCT06078059

Mechanisms of Treatment Effects Using Cultured, Allogeneic Mesenchymal Stromal Stem Cells (MSCs) in Knee Osteoarthritis

A study testing Knee aspiration + UCB-MSCs and Knee aspiration in people with Osteoarthritis, Knee, run by University Medical Centre Ljubljana at 1 site in Slovenia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this clinical trial is to pharmacologically evaluate the effects of culturued allogeneic umbilical cord blood-derived mesenchymal stromal stem cell (UCB-MSCs) in the treatment of end-stage knee osteoarthritis (Kellgren-Lawrence grade 4) with the analysis of soluble biomarkers and expression of key genes… Read more about this study

Who is it for?
Ages 50 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Osteoarthritis, Knee
What is being tested?
Knee aspiration + UCB-MSCs and Knee aspiration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteSlovenia
Study dates
1 Nov 2022to 1 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients with end-stage (Kellgren-Lawrence) knee osteoarthritis scheduled for knee arthroplasty
  • Osteoarthritis of primary or post-traumatic etiology

Who cannot join

  • Secondary arthritis of other etiology
  • Rheumatic diseases
  • Uncontrolled metabolic disorders
  • Crystalopathies
  • Coagulopathy
  • Anticoagulant therapy
Show all 9Show fewer
  • Heart failure
  • Renal failure
  • Other conditions that may affect immune response or pose additional risk during cell application

Trial locations and contacts

1 site in 1 country.

Slovenia1 site

  • University medical centre Ljubljana

    Ljubljana, 1000

Other trials in Slovenia

About this study

The goal of this clinical trial is to pharmacologically evaluate the effects of culturued allogeneic umbilical cord blood-derived mesenchymal stromal stem cell (UCB-MSCs) in the treatment of end-stage knee osteoarthritis (Kellgren-Lawrence grade 4) with the analysis of soluble biomarkers and expression of key genes, as well as the evaluation of clinical outcomes with patient-reported outcome measures (PROMs) and recording of potential complications.

Patients will be randomized in the intervention and control groups. In both groups, the knee aspiration will be performed 4-6 weeks prior to the knee arthroplasty to analyse baseline synovial fluid characteristics. The intervention group will receive the injection of UCB-MSCs. All patients will complete PROMs questionnaires and maintain a pain diary on visual analogue scale (VAS) at home until the surgery. On the day of admission to hospital for knee arthroplasty, the same questionnaires will be administered again. During the operative procedures, the samples of synovial fluid, synovial membrane and resected cartilage will be obtained and analysed afterwards.

It is anticipated that the study results will contribute to elucidate the mechanisms of action of MSCs in the treatment of knee osteoarthritis.

Being tested
Knee aspiration + UCB-MSCs, Knee aspiration
Keywords
Knee, Osteoarthritis, Mesenchymal stem cells, Allogeneic
Medical subject headings
Osteoarthritis, Knee, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Knee aspiration + UCB-MSCsBiological

    Knee aspiration and the application of cultered allogeneic umbilical cord blood-derived mesenchymal stromal stem cells (UCB-MSCs).

  • Knee aspirationOther

    Knee aspiration

Study groups in NCT06078059
Study groupRoleWhat they receive
Intervention groupExperimentalKnee aspiration and the application of UCB-MSCs
Receives: Biological: Knee aspiration + UCB-MSCs
Control groupActive comparatorOnly knee aspiration, without the application of UCB-MSCs
Receives: Other: Knee aspiration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Soluble biomarkers analysis with multiplex bead-based immunoassays Luminex in synovial fluid

    Luminex assay is a type of immunoassay that precisely measures multiple analytes in one sample. It is a bead-based immunoassay that allows for multiplex detection of analytes simultaneously. Color-coded microspheres or beads are internally dyed with different proportions of red and infrared fluorophores that correspond to a distinct spectral signature or bead region. The quantification of multiple cytokines and other biomarkers in samples provides critical information about biological processes and diseases.

    Measured: After sampling

  2. Biomarkers analysis with Enzyme-linked immunosorbent assay (ELISA) in synovial fluid

    Enzyme-linked immunosorbent assay (ELISA) is the main approach for the sensitive quantification of protein biomarkers in body fluids and is currently employed in clinical laboratories for the measurement of clinical markers. It also constitutes the main methodological approach for biomarker validation and further qualification.

    Measured: After sampling

  3. Quantitative real-time PCR (qRT-PCR) analysis of gene expression in chondrocytes and synoviocytes

    Quantitative real-time PCR (qRT-PCR) is a major development of PCR technology that enables reliable detection and measurement of products generated during each cycle of PCR process. The detection of changes in fluorescence intensity during the reaction enables to follow the PCR reaction in real time. qRT-PCR is comprised of several steps: 1. RNA is isolated from target tissue/cells, 2. mRNA is reverse-transcribed to cDNA, 3. modified gene-specific PCR primers are used to amplify a segment of the cDNA of interest, following the reaction in real time, 4. the initial concentration of the selected transcript in a specific tissue or cell type is calculated from the exponential phase of the reaction.

    Measured: After sampling

Secondary outcomes (5)

  1. Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Knee injury and Osteoarthritis Outcome Score (KOOS) assesses patient pain (9 items), other symptoms (7 items), function in daily living (17 items), function in sport and recreation (5 items), and knee related quality of life (4 items). Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms.

    Measured: 4-6 prior to surgery and at admission

  2. Pain on Visual Analogue Scale (VAS)

    The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('the worst pain imaginable').

    Measured: 4-6 prior to surgery and at admission

  3. EuroQol 5-Dimensions 3-Levels (EQ-5D-3L) questionnaire

    EQ-5D-3L descriptive system consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression . Each dimension has 3 levels: no problems, some problems, and extreme problems. The respondent is asked to indicate his or her health state by ticking the box that marks the most appropriate level of problems in each dimension. A unique health state can be described according to the responses to the 5 questions. Health states defined in this way may be converted into a single summary index by applying a formula that attaches values to each of the levels in each dimension. States can be converted to a single value where 1 is equivalent to full health and 0 to a state equivalent to death.

    Measured: 4-6 prior to surgery and at admission

  4. EuroQol self-rated health on Visual Analogue Scale (EQ-VAS)

    EQ-VAS records the patient's self-rated health on a vertical visual analogue scale from 0 to 100, where 0 represents the worst health state imaginable and 100 represents the best health state imaginable.

    Measured: 4-6 prior to surgery and at admission

  5. Serious Adverse Events (SAE)

    Serious adverse events (SAE) are defined as any complication requiring hospitalization.

    Measured: Until 1 month after the application of UCB-MSCs

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Oct 2023
  2. Study start1 Nov 2022
  3. Primary completion1 Oct 2024
  4. Study completion1 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06078059
Sponsor's protocol ID
UMC Ljubljana
Status last verified
Nov 2024
First submitted
23 Jul 2023
Last updated
9 Dec 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Svajger U, Kolar M, Pompe B, Kobold A, Drobnic M. Synovial Biomarker Modulation and Clinical Response to Umbilical Cord-Derived MSC Treatment in Knee Osteoarthritis: A Case Series Study. Cartilage. 2026 Apr 30:19476035261435793. doi: 10.1177/19476035261435793. Online ahead of print.

    PubMed 42060495

  • Svajger U, Kolar M, Kobold A, Drobnic M. Mechanisms of treatment effects using allogeneic, umbilical cord-derived mesenchymal stromal stem cells (MSCs) in knee osteoarthritis: a pharmacological clinical study protocol. Trials. 2024 Aug 13;25(1):533. doi: 10.1186/s13063-024-08360-x.

    PubMed 39135209

Questions about this trial

What is this clinical trial studying?

A study testing Knee aspiration + UCB-MSCs and Knee aspiration in people with Osteoarthritis, Knee, run by University Medical Centre Ljubljana at 1 site in Slovenia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Soluble biomarkers analysis with multiplex bead-based immunoassays Luminex in synovial fluid (time frame: After sampling). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06078059, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.

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