ALLOGENEIC ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS EXPANDED for Knee osteoarthritis

Inclusion criteria

• {"criterion_text":"- Donor"}
• {"criterion_text":"- 1. Male or female aged 40 to <75 years"}
• {"criterion_text":"- 2. Chronic knee pain (defined for at least 6 months with NRS 4 or above when pain worst)"}
• {"criterion_text":"- 3. Patients with Grade II-III osteoarthritis according to the Kellgren Lawrence Classification and a joint width space of 1-3 mm."}
• {"criterion_text":"- 4. Axial hip, knee, ankle x-ray with no more than 5 degrees valgus/varus deformity"}
• {"criterion_text":"- 5. Medial, lateral or dual compartment OA as determined above"}
• {"criterion_text":"- 6. BMI <35"}
• {"criterion_text":"- 7. Danish speaker"}
• {"criterion_text":"- 8. Patients must be legally competent and must be able to sign the written consent"}
• {"criterion_text":"- 1. Male or female aged 18-50 years"}
• {"criterion_text":"- 2. Planned cosmetic operation of excessive fat of abdominal, flank, arm and thigh fat"}
• {"criterion_text":"- 3. BMI 18,5-30"}
• {"criterion_text":"- 4. Non-smokers (defined as smoking cessation >12 weeks)"}
• {"criterion_text":"- 5. Operation of at least 30 mL adipose tissue"}
• {"criterion_text":"- 6. Speaks Danish"}
• {"criterion_text":"- 7. Legally competent and able to sign the written consent"}
• {"criterion_text":"- Patient"}

Exclusion criteria

• {"criterion_text":"- Donor"}
• {"criterion_text":"- 1. Severe Osteoarthritis (Grade IV according to Kellgren Lavrence Classification)"}
• {"criterion_text":"- 2. Intraarticular tumor, infection or fracture"}
• {"criterion_text":"- 3. Pregnancy and breast feeding"}
• {"criterion_text":"- 4. Cognitive impairment"}
• {"criterion_text":"- 5. Treatment with cytostatic drugs"}
• {"criterion_text":"- 6. Previous intraarticular knee injection in the past 3 mo."}
• {"criterion_text":"- 7. Unable to perform MRI scan (non-compatible implants, claustrophobia and severe obesity (>BMI 35)"}
• {"criterion_text":"- 8. Previous ligament reconstruction"}
• {"criterion_text":"- 9. Meniscal operation with resection with more than 50% or multiple meniscal operations (more than one resection)"}
• {"criterion_text":"- 10. Knee instability on physical examination"}
• {"criterion_text":"- 1. Age >50 years"}
• {"criterion_text":"- 11. History of allergy to antibiotics"}
• {"criterion_text":"- 12. Diabetes mellitus type 1 or dysregulated type 2 diabetes"}
• {"criterion_text":"- 13. Concomitant severe infection, malignant tumor, coagulation diseases, autoimmune disease or uncontrolled or unmanaged systemic disease"}
• {"criterion_text":"- 14. Presence of other types of inflammatory arthritis"}
• {"criterion_text":"- 2. BMI >30 or <18,4"}
• {"criterion_text":"- 3. Known comorbidities: diabetes mellitus Type I and II, infectious diseases (HIV, hepatitis B, hepatitis C or syphilis), cancer, autoimmune disorders, metabolic diseases (hyper and hypothyreosis), metabolic syndrome"}
• {"criterion_text":"- 4. Taking immunosuppressive/immunomodulating medication"}
• {"criterion_text":"- 5. Breastfeeding"}
• {"criterion_text":"- 6. Cognitive impairment"}
• {"criterion_text":"- 7. Active smoker"}
• {"criterion_text":"- Patient"}

Primary endpoints

• {"endpoint_text":"- Knee symptoms as evaluated by the Knee Injury and Osteoarthritis Score (KOOS)","definition_or_measurement_approach":"Knee Injury and Osteoarthritis Score (KOOS) assessment"}
• {"endpoint_text":"- Pain diary (first 30 days after AD-MSC or placebo treatment), Adverse events will be collected the first year after AD-MSC or placebo treatment","definition_or_measurement_approach":"Daily pain diary for first 30 days; adverse events collected and recorded over first year post-treatment"}

Secondary endpoints

• {"endpoint_text":"- Cartilage regeneration (MRI Osteoarthritis Knee Score), Quantitative MRI protocol","definition_or_measurement_approach":"MRI-assessed cartilage regeneration using MRI Osteoarthritis Knee Score and quantitative MRI protocol"}
• {"endpoint_text":"- Pain as reported on the Numeric Rating Scale (NRS)","definition_or_measurement_approach":"Patient-reported pain on Numeric Rating Scale (NRS)"}
• {"endpoint_text":"- Range of motion, Effusion tests (swelling), Knee diameter on the patellae (swelling), Atrophy (measure quadriceps muscle bulk 10 cm above the patellae top)","definition_or_measurement_approach":"Clinical examination measures: range of motion, effusion tests, knee diameter at patella, quadriceps muscle bulk measured 10 cm above patella"}

Denmark

Earliest CTIS Part Ii Submission Date

30-11-2023

Latest Decision Or Authorization Date

16-02-2024

Processing Time Days

78

Number Of Sites

1

Number Of Participants

80

Primary sponsor

Full Name

Aarhus University

Organisation Type

Educational Institution

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Region Midtjylland","duties_or_roles":"[codes: 14, 4]","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Denmark","full_name":"Aarhus Universitet","duties_or_roles":"[codes: 1, 9]","organisation_type":"Educational Institution"}