A Study of Autologous Adipose-Derived Stromal Vascular Fraction (SVF) for Treatment of Knee Osteoarthritis

A Single center, Double-blind, Randomized, Phase 4 Study to Evaluate the Efficacy and Safety of Autologous Adipose-Derived Stromal Vascular Fraction (SVF) in Knee Osteoarthritis

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0011317

Enrollment

Registered

2025-12-12

Start date

2020-07-01

Completion date

Unknown

Last updated

2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Biological/Vaccine, Stem Cell : The intervention group received a single intra-articular injection of autologous adipose-derived stromal vascular fraction (SVF) extracted from adipose tissue. The cont

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects who met all of the following criteria were enrolled and analyzed in this clinical trial: 1. Patients aged between 40 and 70 years at screening, diagnosed with knee osteoarthritis. 2. Kellgren-Lawrence grading scale of Grade II or Grade III at screening. 3. Patients experiencing persistent pain despite receiving standard treatments (medication, physical therapy, or injection therapy) for at least 3 months prior to screening. 4. Patients with Body Mass Index (BMI) less than 35. 5. Patients having a Visual Analogue Scale (VAS) pain score of 4 or higher prior to randomization. 6. Patients who could undergo MRI scans. 7. Patients who voluntarily signed informed consent after sufficient explanation about this clinical trial.

Exclusion criteria

Exclusion criteria: Patients meeting any of the following criteria were excluded from this clinical trial: 1. History of immune suppression or autoimmune disease. 2. Patients requiring a walking cane for daily activities. 3. Patients with coagulopathy or undergoing anticoagulant therapy. 4. History of surgery on the study knee, including cartilage regenerative surgery. 5. Cortisone or hyaluronic acid intra-articular injection in the study knee within the last 3 months. 6. Active malignant tumors. 7. Patients judged by the investigator to be mentally unstable or unable to comply with study protocols. 8. Participation in another clinical trial within 4 weeks prior to screening. 9. Pregnant or lactating women, women planning pregnancy, or women of childbearing potential who did not consent to adequate contraception methods. 10. Severe allergy to local anesthetics. 11. Patients with uncontrolled severe chronic conditions, such as diabetes, hypertension, cardiac disease, liver or kidney disease, epilepsy, etc. 12. Known hypersensitivity to Ultracet®. 13. Severe respiratory depression. 14. Risk of impaired consciousness due to head injury or brain lesion. 15. Patients taking monoamine oxidase (MAO) inhibitors within 14 days prior to baseline. 16. Clinically significant peptic ulcers or severe hematological disorders. 17. History of aspirin-induced asthma or NSAID-related asthma. 18. History of receiving SVF therapy within 6 months prior to screening. 19. Severe metal allergy. 20. Patients otherwise deemed inappropriate for the study by the investigator.

Design outcomes

Primary

Measure	Time frame
Change from baseline in pain score (Visual Analogue Scale, VAS) at week 12	—

Secondary

Measure	Time frame
Change from baseline in pain score (VAS);WOMAC scores;Change from baseline in SF-36 scores at weeks 4, 12, 24, and 48;Change from baseline in knee strength (Peak Torque and Work per Repetition via Cybex test) at weeks 4, 12, 24, and 48;Change from baseline in cartilage structure (Total WORMS scores via MRI) at week 48;Change from baseline in Range of Motion (ROM) and walking distance at week 4	—

Countries

Korea, Republic of

Contacts

Public ContactHan Eol Cho

Yonsei University Health System, Gangnam Severance Hospital

wtzephyr@yuhs.ac+82-2-2019-3500

Outcome results