NCT07898501 SVF Cellular Composition, Secretome, and Responses in Knee Osteoarthritis
| NCT ID | NCT07898501 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yonsei University |
| Condition | Osteoarthritis, Knee |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-11-01 |
| Primary Completion | 2028-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2026-11-01 with a primary completion date of 2028-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07898501 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 75 Years, studying Osteoarthritis, Knee. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07898501 currently recruiting?
Yes, NCT07898501 is actively recruiting participants. Contact the research team at orthohwan@yuhs.ac for enrollment information.
Where is the NCT07898501 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT07898501 clinical trial?
NCT07898501 is sponsored by Yonsei University. The trial plans to enroll 20 participants.