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

University Medical Centre Ljubljana

Status: Completed

Conditions: Osteoarthritis, Knee

Treatments: Biological: Knee aspiration + UCB-MSCs; Other: Knee aspiration

Study type: Interventional

Funder types: Other

Identifiers

NCT06078059

UMC Ljubljana

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

Intervention group

Experimental group

Description:

Knee aspiration and the application of UCB-MSCs

Treatment:

Biological: Knee aspiration + UCB-MSCs

Control group

Active Comparator group

Description:

Only knee aspiration, without the application of UCB-MSCs

Treatment:

Other: Knee aspiration