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ACTIVE NOT RECRUITING
NCT07405840
PHASE4

Application of Autologous Stem Cells From Adipose Tissue in the Regeneration of Knee Joint Cartilage

Sponsor: Clinical Center of Vojvodina

View on ClinicalTrials.gov

Summary

This randomized, controlled clinical trial will evaluate the safety and effectiveness of autologous adipose-derived stromal vascular fraction (SVF) therapy in patients with knee osteoarthritis (OA) grades II-IV, compared with standard chondroprotective (CP) treatment. The study will enroll male and female patients and follow them for 12 months, assessing pain (VAS), function (WOMAC, KOOS, SF-36), radiologic progression, and safety (adverse events). The trial aims to determine whether SVF therapy provides superior clinical outcomes and to inform evidence-based recommendations for OA management in the Serbian population.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-06-25

Completion Date

2027-12-31

Last Updated

2026-02-12

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

stromal vascular fraction (SVF)

Participants will undergo autologous adipose tissue harvesting under local anesthesia. The adipose tissue (1-5 mL) will be processed using the Lipocube® mechanical closed system to isolate stromal vascular fraction (SVF), containing adipose-derived stem cells (ADSCs), pericytes, and regenerative stromal cells. The prepared SVF will be injected intra-articularly into the affected knee under sterile conditions.

DRUG

CP

Participants will receive a single intra-articular injection of high-molecular-weight hyaluronic acid (Reviscon Re-Cross, MV Pharm; 88 mg sodium hyaluronate \[2.2%\] in 4 mL solution) under sterile conditions.

Locations (1)

University Clinical Center of Vojvodina

Novi Sad, Vojvodina, Serbia