Personalized treatment of knee osteoarthritis with fat tissue containing stem cells

Phase 2

• Conditions: Knee osteoarthritis; Musculoskeletal Diseases

• Registration Number: ISRCTN88966184
• Lead Sponsor: St Catherine Specialty Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-08-01
• Last Update Posted: 28 August 2023
• Study Completion: 2023-08-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Patients with osteoarthritis of the knee who are aged 30-75 years old
2. Osteoarthritis grade 2-3 based on Kellgren-Lawrence classification
3. Patellofemoral osteoarthritis Iwano grade 2-3
4. Presence of knee pain for at least six months
5. Patients who have lower limb axis deviation less than 5°
6. The possibility of following research instructions and responding to control examinations
7. Signed informed consent for participation in the research

Exclusion Criteria

1. Malignant diseases, systemic inflammatory diseases (e.g. rheumatoid arthritis, psoriatic arthritis) or other systemic diseases that can result in knee pain or cause systemic inflammation
2. A body mass index (BMI) greater than 30 or diabetes
3. Six or more painful points on the body, distributed above and below the waist, on both sides of the body and in the axilla
4. Depression (determined according to the CESD-R questionnaire)
5. Stage 4 of the Kellgren-Lawrence classification for knee osteoarthritis, stage 4 of the Iwano classification of patellofemoral arthrosis
6. A MOAKS score for synovitis or effusion less than 2 (patients without knee effusion)
7. Post-traumatic osteoarthritis
8. A history of surgery on the affected knee
9. A deviation of the mechanical axis (valgus/varus) of the lower extremities greater than 5°
10. An unstable knee
11. Damage to the meniscus or other knee structures as the main cause of pain and other symptoms (radial rupture and bucket-handle rupture of the meniscus, ACL rupture, subchondral cysts according to MRI)
12. An injury of the affected knee in the last 3 months
13. Received an intra-articular injection in the affected knee (corticosteroids, hyaluronic acid, platelet-rich plasma, etc.) within the last 3 months
14. Other musculoskeletal problems/diseases (genetic diseases such as Marfan syndrome or osteogenesis imperfecta) that would prevent clinical evaluation of the effects of MFAT or HA treatment
15. Unable to abstain from oral non-steroidal anti-inflammatory drugs (NSAIDs) for 7 days prior to MFAT or HA application and during the 6-month follow-up
16. Allergy to lidocaine and adrenaline
17. A blood coagulation disorder, thrombocytopenia or patients on anticoagulant therapy with a prothrombin time <0.70
18. Systemic immunosuppressive therapy
19. Chondromatosis or villonodular synovitis of the knee joint
20. Knee joint infection
21. Pregnancy or planning to become pregnant during the study period
22. History of chemotherapy or radiotherapy of the extremities or in the area of fat tissue extraction
23. Mental illnesses (who cannot be expected to cooperate during the project)
24. Unable to respond to follow-up examinations

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Knee symptoms, pain and function measured by patient-reported outcomes measures (PROMs) using a visual analog scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Knee Injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee (IKDC), Oxford Knee Score and Tegner/Lysholm knee score at baseline, 1-month and 6-month follow up