ClinicalTrials.gg
RecruitingNCT07898501Updated Oct 27, 2026

SVF Cellular Composition, Secretome, and Responses in Knee Osteoarthritis

An observational study in Osteoarthritis, Knee, sponsored by Yonsei University. Recruiting at 1 site in South Korea. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by Yonsei University · Observational

Updated Oct 27, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
40 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 96 studies in Osteoarthritis, Knee with a site in Korea, Republic of — 13 open to participants now, 21 under way, 4 of them phase 3. Osteoarthritis, Knee · Korea, Republic of.

Planned enrollment
11th of 11
20 · median 50
Started
2026
with 4 others
Observational
11 of 96
4 open now
Primary completion
2028-09
later than 19 of 20 live
Registered
95th of 96
by date
Lead sponsor
6 of 96
Yonsei University

Among the 96 studies in Osteoarthritis, Knee with a site in Korea, Republic of, this one is the 11th largest by planned enrollment of the 11 observational ones that give a count, is one of 5 that started in 2026, is one of 11 observational ones, reaches primary completion later than 19 of the 20 other live ones, and was the 95th registered.

Osteoarthritis, Knee

3,292 studies on the registry are indexed under Osteoarthritis, Knee; 621 are open to participants now.

Browse Osteoarthritis, Knee studies →

Open to participants now

13 of the 96 studies in Osteoarthritis, Knee with a site in Korea, Republic of are open now. Recruiting first, the newest first:

7 more — sign in →

All 13 open studies →

A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →

Who these studies take

Of the 382 Osteoarthritis, Knee studies recruiting now, 176 (46%) set no upper age limit and 113 (30%) stop at 75 or younger; 19 take children under 18; 39 take healthy volunteers.

This study: 40 Years to 75 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 96 studies in Osteoarthritis, Knee with a site in Korea, Republic of, or all of them as a file.
02

Study 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.

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.

03

Conditions studied

  • Osteoarthritis, Knee

Keywords

  • Stromal vascular fraction (SVF)
  • autologous adipose-derived cells
  • cellular composition
  • secretome
  • synovial fluid
  • biomarkers
  • Luminex
  • knee osteoarthritis
  • Cell Unit
04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 . 7. Ability to comply with follow-up and assessments.

Exclusion criteria

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. ≥35 kg/m². 5. Prior total/partial target-knee arthroplasty.

6. Target-knee surgery/arthroscopy within 6 months before screening. 7. Target-knee /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 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.

Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    Biological: Autologous adipose-derived stromal vascular fraction intra-articular injection

Interventions

  • BiologicalAutologous 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.

    Also known as: Autologous SVF, adipose-derived stromal vascular fraction

06

What researchers measure

Primary outcomes

  1. Red blood cell contamination of research-only SVF

    Red blood cell contamination proportion in research-only SVF.

    Time frame: Baseline (procedure day)

  2. Total nucleated cell count of research-only SVF

    Number of nucleated cells in research-only SVF.

    Time frame: Baseline (procedure day)

  3. MSC-like stromal progenitor cell composition

    Research-only SVF cells with the protocol phenotype CD73+, CD90+, CD146+/CD45-, CD31-.

    Time frame: Baseline (procedure day)

  4. CD34-positive adipose stromal progenitor cell composition

    Research-only SVF CD34+ adipose stromal progenitor cells.

    Time frame: Baseline (procedure day)

  5. 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.

    Time frame: Baseline (procedure day)

  6. 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.

    Time frame: Immediately before injection and 6 months after injection

Secondary outcomes

  1. Change from baseline in pain VAS at 6 months

    Activity-related knee pain VAS, 0-10; higher scores indicate greater pain.

    Time frame: Baseline and 6 months after injection

  2. 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.

    Time frame: Baseline and 6 months after injection

  3. 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.

    Time frame: Baseline and 6 months after injection

  4. Change from baseline in IKDC subjective score at 6 months

    IKDC subjective score, 0-100; higher scores indicate better function and fewer symptoms.

    Time frame: Baseline and 6 months after injection

  5. 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.

    Time frame: Baseline and 6 months after injection

  6. Change from baseline in knee joint space at 6 months

    Medial and lateral knee joint space widths, recorded separately in millimeters on knee radiographs.

    Time frame: Baseline and 6 months after injection

  7. Change from baseline in osteophytes at 6 months

    Osteophyte severity recorded as absent, mild, moderate, or severe. Changes in grade and worsening are assessed.

    Time frame: Baseline and 6 months after injection

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — A decision has not yet been made about sharing individual participant data with other researchers.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Sep 2028, 22 months later.

Of 179 non-industry observational studies under Osteoarthritis, Knee, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 22 months is close to that.

Counting every sponsor, half of 220 studies reached it within 24 months; a quarter within 14 and three quarters within 61.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 20, 2026
First posted
Oct 27, 2026
StartEst.
Nov 1, 2026
Primary completionEst.
Sep 30, 2028
CompletionEst.
Sep 30, 2028
Last update
Oct 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 27, 2026
Show all 1 update
  1. Oct 27, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07898501
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Oct 27, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Sep 30, 2028 (estimated)
Completion
Sep 30, 2028 (estimated)
Last update
Oct 27, 2026

Study contacts

Sung-Hwan Kim, Professor
Contact
orthohwan@yuhs.ac
+82-2-2228-5679

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion