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RECRUITING
NCT07898501

SVF Cellular Composition, Secretome, and Responses in Knee Osteoarthritis

Sponsor: Yonsei University

View on ClinicalTrials.gov

Summary

This prospective, single-center observational study will enroll 20 adults aged 40 to 75 years with Kellgren-Lawrence grade II or III knee osteoarthritis who have already been scheduled for an intra-articular injection of autologous adipose-derived stromal vascular fraction (SVF) as clinical care. The study does not assign treatment, use a control group, or randomize participants. After preparation of the therapeutic SVF, residual adipose tissue will be processed independently with a new disposable kit to obtain research-only SVF. No additional adipose tissue will be harvested for research, and research-only SVF will not be injected. Cellular composition and secretome characteristics of research-only SVF will be measured. Synovial fluid biomarkers will be assessed before injection and at 6 months using the same 12-analyte panel. Patient-reported outcomes and knee radiographs will also be compared between baseline and 6 months. CGBio provides research funding and research-only processing kits without involvement in study conduct, analysis, or publication decisions.

Official title: Cellular Composition and Secretome Characteristics of Autologous Adipose-Derived Stromal Vascular Fraction and Biological and Clinical Responses Following Intra-Articular Injection in Patients With Knee Osteoarthritis: A Prospective Observational Study

Key Details

Gender

All

Age Range

40 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

20

Start Date

2026-11-01

Completion Date

2028-09-30

Last Updated

2026-10-27

Healthy Volunteers

No

Interventions

BIOLOGICAL

Autologous adipose-derived stromal vascular fraction intra-articular injection

As clinical care, approximately 200 mL of abdominal lipoaspirate is collected under general anesthesia after tumescent infiltration. SVF is prepared using the CGBio Cell Unit closed automated processing system, concentrated to approximately 5 mL, and injected once into the affected knee. The decision to perform this treatment precedes research enrollment. Research-only SVF is separately prepared from residual adipose tissue using a new kit and is never administered to participants.

Locations (1)

Yonsei University College of Medicine

Seoul, South Korea