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

NCT ID: NCT06078059

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2024-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoarthritis, Knee

Keywords

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Knee Osteoarthritis Mesenchymal stem cells Allogeneic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention group

Knee aspiration and the application of UCB-MSCs

Group Type EXPERIMENTAL

Knee aspiration + UCB-MSCs

Intervention Type BIOLOGICAL

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

Control group

Only knee aspiration, without the application of UCB-MSCs

Group Type ACTIVE_COMPARATOR

Knee aspiration

Intervention Type OTHER

Knee aspiration

Interventions

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Knee aspiration + UCB-MSCs

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

Intervention Type BIOLOGICAL

Knee aspiration

Knee aspiration

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Secondary arthritis of other etiology
* Rheumatic diseases
* Uncontrolled metabolic disorders
* Crystalopathies
* Coagulopathy
* Anticoagulant therapy
* Heart failure
* Renal failure
* Other conditions that may affect immune response or pose additional risk during cell application
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Blood Transfusion Centre of Slovenia

OTHER_GOV

Sponsor Role collaborator

University Medical Centre Ljubljana

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matej Drobnič, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Centre Ljubljana

Urban Švajger, MPharm, PhD

Role: PRINCIPAL_INVESTIGATOR

Blood Transfusion Centre of Slovenia

Locations

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University medical centre Ljubljana

Ljubljana, , Slovenia

Site Status

Countries

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Slovenia

References

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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.

Reference Type DERIVED
PMID: 39135209 (View on PubMed)

Other Identifiers

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UMC Ljubljana

Identifier Type: -

Identifier Source: org_study_id