NCT06078072

Biomaterials and Mesenchymal Stem/Stromal Cells in the Treatment of Knee Articular Surface Lesions

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 90 (actual)
• Sponsor: University Medical Centre Ljubljana · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: —

Summary

The goal of this observational study is to evaluate the combined single-step approach with biomaterials and mesenchymal stem/stromal cells in the treatment of knee articular surface lesions. The clinical analysis of the treatment outcomes, regarding postoperative improvements and safety, is going to be accompanied with laboratory analysis of the intraoperatively applied cellular products. The main hypothesis are: (1) such combined single-step procedure significantly improves patients' functioning and quality of life; (2) this therapeutic approach is safe; (3) cellular parameters of the applied filtered bone marrow aspirate (fBMA) impact treatment outcomes, among other potential predictors. Researchers will compare subjective (questionnaire) and objective (clinical examination) status of patients before and after the operation, record any potential complications and perform regression analysis to assess the influence of potential predictors on postoperative improvements.

Conditions

• Knee Injuries
• Cartilage Injury
• Osteochondral Defect

Interventions

Type	Name	Description
PROCEDURE	Biomaterials augmented with mesenchymal stem/stromal cells	Combined single-step procedure of treating knee articular surface lesions with biomaterials (scaffolds) and mesenchymal stem cells (filtered bone marrow aspirate concentrate)

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-08-31
• Completion: 2023-10-31
• First posted: 2023-10-11
• Last updated: 2023-11-30

Locations

1 site across 1 country: Slovenia