Allogenic mesenchymal stem cell intraarticular injection for knee osteoarthritis therapy, an RCT explorative mode-of-action study

Phase 1

Recruiting

Conditions: knee osteoarthritis
MedDRA version: 21.1Level: LLTClassification code: 10023476Term: Knee osteoarthritis Class: 10028395
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: CTIS2023-506088-33-01

Lead Sponsor: Aarhus University

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 80

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the safety and clinical efficiency (knee symptoms) of intraarticular knee injection of adipose derived mesenchymal stem cells compared to intraarticular knee placebo injection;Secondary Objective: To objectively evaluate whether AD-MSC treatment leads to cartilage regeneration on MRI (MRI Osteoarthritis Knee Score and Quantitative MRI protocol, To evaluate whether AD-MSC treatment leads to pain reduction on a NRS scale, To objectively evaluate whether AD-MSC treatment leads to improvement in function and clinical signs based on clinical examination (Range of motion, Effusion tests (swelling), Knee diameter on the patellae (swelling), Atrophy (measure quadriceps muscle bulk 10 cm above the patellae top);Primary end point(s): Knee symptoms as evaluated by the Knee Injury and Osteoarthritis Score (KOOS), 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

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Cartilage regeneration (MRI Osteoarthritis Knee Score), Quantitative MRI protocol;Secondary end point(s):Pain as reported on the Numeric Rating Scale (NRS);Secondary end point(s):Range of motion, Effusion tests (swelling), Knee diameter on the patellae (swelling), Atrophy (measure quadriceps muscle bulk 10 cm above the patellae top)

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