SVF cellular mix, secretome, and knee response in osteoarthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, single-center observational pilot enrolls 20 adults with Kellgren-Lawrence grade II/III knee OA to characterize the research-only SVF produced from residual adipose tissue and to measure changes in synovial fluid biomarkers and patient-reported outcomes over six months. No randomization or control group is used; the clinical SVF injection is not directed by the study. Researchers will compare baseline and six-month synovial fluid analytes, imaging, and patient-reported outcomes to explore potential associations with the therapeutic process. The study uses a 12-analyte Luminex panel to profile biomarkers such as VEGF, IL-6, IL-1β, and MMPs in synovial fluid and SVF. Primary aims are descriptive characterization of the research-only SVF and biomarker dynamics, with secondary clinical outcomes tracked at baseline and six months.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 40-75 years at written consent; all sexes.
2. ACR-defined primary knee osteoarthritis; target-knee pain for at least 3 months.
3. Target-knee Kellgren-Lawrence grade II or III.
4. Baseline activity pain VAS at least 4/10.
5. Persistent symptoms despite conservative therapy; prior clinical decision for SVF injection.
6. Voluntary written informed consent. 7. Ability to comply with follow-up and assessments.

Exclusion Criteria:

1. Target-knee Kellgren-Lawrence grade I or IV.
2. Secondary arthritis (infectious, rheumatoid, gouty, reactive, or other causes).
3. Relevant joint disease affecting assessment: recurrent pseudogout, intra-articular fracture, hemochromatosis, Wilson disease, inherited connective-tissue disease, or other significant disease.
4. BMI ≥35 kg/m². 5. Prior total/partial target-knee arthroplasty.

6\. Target-knee surgery/arthroscopy within 6 months before screening. 7. Target-knee steroid/PRP injection within 3 months before screening. 8. Target-knee hyaluronic acid injection within 1 month before screening. 9. Target-knee cell therapy/SVF/other regenerative injection within 6 months before screening.

10\. Active systemic infection or local infection at donor site/target knee. 11. Severe cardiovascular/hepatic/renal or uncontrolled systemic disease increasing procedural risk.

12\. Active malignancy under treatment or investigator-determined unsuitable cancer history.

13\. Inability to undergo protocol knee radiographs. 14. Pregnancy/breastfeeding.

15\. Inadequate donor fat for safe liposuction. 16. Cognitive/psychiatric impairment or alcohol/drug dependence preventing understanding/cooperation.

Where it's running

• Yonsei University College of Medicine
  Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Sung-Hwan Kim, Professor
• Email: orthohwan@yuhs.ac
• Phone: +82-2-2228-5679

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.