Osteoarthritis, KneeNCT07898501
SVF Cellular Composition, Secretome, and Responses in Knee Osteoarthritis
An observational study of Osteoarthritis, Knee, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Autologous adipose-derived stromal vascular fraction intra-articular injection
- Type of treatment
- Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Nov 2026to 30 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults aged 40-75 attending the Department of Orthopedic Surgery, Severance Hospital, with symptomatic primary knee osteoarthritis of Kellgren-Lawrence grade II or III, persistent symptoms despite conservative therapy, and a prior clinical decision to receive autologous SVF injection. Only patients meeting the protocol eligibility criteria and providing written consent are enrolled.
Who may be able to join
- Age 40-75 years at written consent; all sexes.
- ACR-defined primary knee osteoarthritis; target-knee pain for at least 3 months.
- Target-knee Kellgren-Lawrence grade II or III.
- Baseline activity pain VAS at least 4/10.
- Persistent symptoms despite conservative therapy; prior clinical decision for SVF injection.
- Voluntary written informed consent. 7. Ability to comply with follow-up and assessments.
Who cannot join
- Target-knee Kellgren-Lawrence grade I or IV.
- Secondary arthritis (infectious, rheumatoid, gouty, reactive, or other causes).
- Relevant joint disease affecting assessment: recurrent pseudogout, intra-articular fracture, hemochromatosis, Wilson disease, inherited connective-tissue disease, or other significant disease.
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University College of Medicine
Seoul
Sung-Hwan Kim, Professor, +82-2-2228-5679, orthohwan@yuhs.ac
About this study
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
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.
Read the detailed description
This single-center prospective observational pilot study enrolls 20 adults with primary knee osteoarthritis (Kellgren-Lawrence grade II or III), aiming for 16 evaluable participants. The clinical decision for autologous SVF injection precedes enrollment. No treatment is assigned by the study, and there is no control group, randomization, or masking.
As clinical care, approximately 200 mL of abdominal lipoaspirate is harvested under general anesthesia after tumescent infiltration. The CGBio Cell Unit system prepares therapeutic SVF, concentrated to approximately 5 mL and injected once into the affected knee. Residual adipose tissue is independently processed with a new kit for research-only SVF. No additional adipose harvest is performed, and research-only SVF is not administered.
Primary assessments characterize research-only SVF cellular composition and secretome, and changes in synovial fluid biomarkers. The same 12-analyte Luminex panel is applied to research-only SVF and synovial fluid immediately before injection and at 6 months: HGF, VEGF-A, IGF-1, IL-1β/IL-1F2, IL-1Ra/IL-1F3, IL-6, IL-10, PGE2, IL-8/CXCL8, MMP-3, MMP-13, and COMP. Synovial fluid collection is 1-5 mL; samples below 1 mL are not analyzed. The six-month aspiration is an additional research procedure.
Visits occur at baseline and 6 months (V2 window: ±1 week). Secondary assessments are pain VAS, WOMAC, KOOS, IKDC subjective score, Kellgren-Lawrence grade, joint space, and osteophytes. Paired analyses emphasize estimates and 95% confidence intervals, with Benjamini-Hochberg correction for the 12 synovial fluid biomarkers. Associations are exploratory; missing values are not imputed.
IRB-approved research period: 18 October 2026 to 17 October 2028. CGBio provides KRW 60,000,000 and research-only kits. Investigators and the institution retain responsibility for study conduct, data, analysis, and publication.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Autologous adipose-derived stromal vascular fraction intra-articular injection
- Keywords
- Stromal vascular fraction (SVF), autologous adipose-derived cells, cellular composition, secretome, synovial fluid, biomarkers, Luminex, knee osteoarthritis, Cell Unit
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous adipose-derived stromal vascular fraction intra-articular injectionBiological
Also called Autologous SVF, adipose-derived stromal vascular fraction
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.
| Study group | Role | What they receive |
|---|---|---|
| Knee osteoarthritis treated with autologous SVF | Adults aged 40-75 with Kellgren-Lawrence grade II or III primary knee osteoarthritis and a clinical decision for autologous SVF injection made before research enrollment. Biological, clinical, and radiographic outcomes are observed through 6 months. Receives: Biological: Autologous adipose-derived stromal vascular fraction intra-articular injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Red blood cell contamination of research-only SVF
Red blood cell contamination proportion in research-only SVF.
Measured: Baseline (procedure day)
Total nucleated cell count of research-only SVF
Number of nucleated cells in research-only SVF.
Measured: Baseline (procedure day)
MSC-like stromal progenitor cell composition
Research-only SVF cells with the protocol phenotype CD73+, CD90+, CD146+/CD45-, CD31-.
Measured: Baseline (procedure day)
CD34-positive adipose stromal progenitor cell composition
Research-only SVF CD34+ adipose stromal progenitor cells.
Measured: Baseline (procedure day)
Research-only SVF secretome analyte concentrations
Individual concentrations of HGF, VEGF-A, IGF-1, IL-1β/IL-1F2, IL-1Ra/IL-1F3, IL-6, IL-10, PGE2, IL-8/CXCL8, MMP-3, MMP-13, and COMP.
Measured: Baseline (procedure day)
Change from baseline in synovial fluid biomarker concentrations at 6 months
Paired change in each of the same 12 analytes listed in outcome 5. Each analyte is assessed individually. Six-month synovial fluid concentrations are recorded in pg/mL; paired measurements use the same units.
Measured: Immediately before injection and 6 months after injection
Secondary outcomes (7)
Change from baseline in pain VAS at 6 months
Activity-related knee pain VAS, 0-10; higher scores indicate greater pain.
Measured: Baseline and 6 months after injection
Change from baseline in WOMAC at 6 months
WOMAC total score, 0-96, with pain (0-20), stiffness (0-8), and physical function (0-68) subscales. Higher scores indicate worse symptoms or disability.
Measured: Baseline and 6 months after injection
Change from baseline in KOOS at 6 months
KOOS symptoms, pain, activities of daily living, sport/recreation, and knee-related quality-of-life subscales, each 0-100; higher scores indicate better status. Subscales are assessed separately.
Measured: Baseline and 6 months after injection
Change from baseline in IKDC subjective score at 6 months
IKDC subjective score, 0-100; higher scores indicate better function and fewer symptoms.
Measured: Baseline and 6 months after injection
Change from baseline in Kellgren-Lawrence grade at 6 months
Radiographic Kellgren-Lawrence grade; higher grades indicate greater severity. Baseline grade II/III and six-month grades I-IV are recorded in the CRF.
Measured: Baseline and 6 months after injection
Change from baseline in knee joint space at 6 months
Medial and lateral knee joint space widths, recorded separately in millimeters on knee radiographs.
Measured: Baseline and 6 months after injection
Change from baseline in osteophytes at 6 months
Osteophyte severity recorded as absent, mild, moderate, or severe. Changes in grade and worsening are assessed.
Measured: Baseline and 6 months after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07898501
- Sponsor's protocol ID
- 4-2026-1408
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A decision has not yet been made about sharing individual participant data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07898501
- Acronym / sponsor ID
- 4-2026-1408
- Conditions
- Osteoarthritis, Knee
- Keywords
- Stromal vascular fraction (SVF), autologous adipose-derived cells, cellular composition, secretome, synovial fluid, biomarkers, Luminex, knee osteoarthritis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 27 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This single-center prospective observational pilot study enrolls 20 adults with primary knee osteoarthritis (Kellgren-Lawrence grade II or III), aiming for 16 evaluable participants. The clinical decision for autologous SVF injection precedes enrollment. No treatment is assigned by the study, and there is no control group, randomization, or masking.
As clinical care, approximately 200 mL of abdominal lipoaspirate is harvested under general anesthesia after tumescent infiltration. The CGBio Cell Unit system prepares therapeutic SVF, concentrated to approximately 5 mL and injected once into the affected knee. Residual adipose tissue is independently processed with a new kit for research-only SVF. No additional adipose harvest is performed, and research-only SVF is not administered.
Primary assessments characterize research-only SVF cellular composition and secretome, and changes in synovial fluid biomarkers. The same 12-analyte Luminex panel is applied to research-only SVF and synovial fluid immediately before injection and at 6 months: HGF, VEGF-A, IGF-1, IL-1β/IL-1F2, IL-1Ra/IL-1F3, IL-6, IL-10, PGE2, IL-8/CXCL8, MMP-3, MMP-13, and COMP. Synovial fluid collection is 1-5 mL; samples below 1 mL are not analyzed. The six-month aspiration is an additional research procedure.
Visits occur at baseline and 6 months (V2 window: ±1 week). Secondary assessments are pain VAS, WOMAC, KOOS, IKDC subjective score, Kellgren-Lawrence grade, joint space, and osteophytes. Paired analyses emphasize estimates and 95% confidence intervals, with Benjamini-Hochberg correction for the 12 synovial fluid biomarkers. Associations are exploratory; missing values are not imputed.
IRB-approved research period: 18 October 2026 to 17 October 2028. CGBio provides KRW 60,000,000 and research-only kits. Investigators and the institution retain responsibility for study conduct, data, analysis, and publication.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Knee osteoarthritis treated with autologous SVF | – | Biological: Autologous adipose-derived stromal vascular fraction intra-articular injectionAdults aged 40-75 with Kellgren-Lawrence grade II or III primary knee osteoarthritis and a clinical decision for autologous SVF injection made before research enrollment. Biological, clinical, and radiographic outcomes are observed through 6 months. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 40-75 attending the Department of Orthopedic Surgery, Severance Hospital, with symptomatic primary knee osteoarthritis of Kellgren-Lawrence grade II or III, persistent symptoms despite conservative therapy, and a prior clinical decision to receive autologous SVF injection. Only patients meeting the protocol eligibility criteria and providing written consent are enrolled.
Key inclusion criteria (6 listed)
- Age 40-75 years at written consent; all sexes.
- ACR-defined primary knee osteoarthritis; target-knee pain for at least 3 months.
- Target-knee Kellgren-Lawrence grade II or III.
- Baseline activity pain VAS at least 4/10.
- Persistent symptoms despite conservative therapy; prior clinical decision for SVF injection.
Key exclusion criteria (9 listed)
- Target-knee Kellgren-Lawrence grade I or IV.
- Secondary arthritis (infectious, rheumatoid, gouty, reactive, or other causes).
- Relevant joint disease affecting assessment: recurrent pseudogout, intra-articular fracture, hemochromatosis, Wilson disease, inherited connective-tissue disease, or other significant disease.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous adipose-derived stromal vascular fraction intra-articular injectionAlso: Autologous SVF, adipose-derived stromal vascular fractionAs 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. | Biological | Knee osteoarthritis treated with autologous SVF |
Primary outcome
Red blood cell contamination of research-only SVF
Time frame: Baseline (procedure day)
Red blood cell contamination proportion in research-only SVF.
Total nucleated cell count of research-only SVF
Time frame: Baseline (procedure day)
Number of nucleated cells in research-only SVF.
MSC-like stromal progenitor cell composition
Time frame: Baseline (procedure day)
Research-only SVF cells with the protocol phenotype CD73+, CD90+, CD146+/CD45-, CD31-.
CD34-positive adipose stromal progenitor cell composition
Time frame: Baseline (procedure day)
Research-only SVF CD34+ adipose stromal progenitor cells.
Research-only SVF secretome analyte concentrations
Time frame: Baseline (procedure day)
Individual concentrations of HGF, VEGF-A, IGF-1, IL-1β/IL-1F2, IL-1Ra/IL-1F3, IL-6, IL-10, PGE2, IL-8/CXCL8, MMP-3, MMP-13, and COMP.
Change from baseline in synovial fluid biomarker concentrations at 6 months
Time frame: Immediately before injection and 6 months after injection
Paired change in each of the same 12 analytes listed in outcome 5. Each analyte is assessed individually. Six-month synovial fluid concentrations are recorded in pg/mL; paired measurements use the same units.
7 secondary outcomes
Change from baseline in pain VAS at 6 months
Time frame: Baseline and 6 months after injection
Change from baseline in WOMAC at 6 months
Time frame: Baseline and 6 months after injection
Change from baseline in KOOS at 6 months
Time frame: Baseline and 6 months after injection
Change from baseline in IKDC subjective score at 6 months
Time frame: Baseline and 6 months after injection
Change from baseline in Kellgren-Lawrence grade at 6 months
Time frame: Baseline and 6 months after injection
Change from baseline in knee joint space at 6 months
Time frame: Baseline and 6 months after injection
Change from baseline in osteophytes at 6 months
Time frame: Baseline and 6 months after injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Undecided. A decision has not yet been made about sharing individual participant data with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sung-Hwan Kim, Professor (+82-2-2228-5679, orthohwan@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Red blood cell contamination of research-only SVF (time frame: Baseline (procedure day)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.