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NCT06078059
Mechanisms of Treatment Effects Using Cultured, Allogeneic Mesenchymal Stromal Stem Cells (MSCs) in Knee Osteoarthritis
NA trial testing Knee aspiration + UCB-MSCs in Osteoarthritis, Knee in 30 participants. Completed in 1 December 2024.
1 October 2024
Quick facts
| Lead sponsor | University Medical Centre Ljubljana |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 1 November 2022 |
| Primary completion | 1 October 2024 |
| Estimated completion | 1 December 2024 |
| Sites | 1 location across Slovenia |
Drugs / interventions tested
- Knee aspiration + UCB-MSCs — full drug profile →
- Knee aspiration
Conditions studied
- Osteoarthritis, Knee — all drugs for Osteoarthritis, Knee →
Sponsor
University Medical Centre Ljubljana
Who can join
Adults 50 to 75, any sex, with Osteoarthritis, Knee. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06078059
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Osteoarthritis, Knee
Currently open trials in the same condition.
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- NCT07386561 — Virtual Reality Therapy and Non-Sleep Deep Rest Relaxation After Joint Arthroplasty · NA · active not recruiting
- NCT07514598 — Effect of J-Shaped Incision After Total Knee Arthroplasty (J-TKA) · NA · active not recruiting
- NCT07058623 — Nurse-Led Telehealth vs In-Person Follow-Up After Total Knee Replacement · NA · recruiting
Other University Medical Centre Ljubljana trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06078059 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Medical Centre Ljubljana
- Last refreshed: 9 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06078059.
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