Allogenic Mesenchymal Stem Cell Intraarticular Injection for Knee Osteoarthritis Therapy
Phase 1
Recruiting
- Conditions
- Knee Osteoarthritis
- Interventions
- Biological: Allogenic adipose derived mesenchymal stem cells (AD-MSC)Other: Saline
- Registration Number
- NCT05933434
- Lead Sponsor
- Aarhus University Hospital
- Brief Summary
This phase I and II double blinded randomized clinical controlled trial investigates the safety and efficacy of intraarticular knee injection with allogenic adipose derived mesenchymal stem cells (AD-MSC), in patients suffering from mild-moderate knee osteoarthritis compared to placebo injection with saline.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
- Chronic knee pain (defined for at least 6 months with NRS 4 or above when pain worst)
- Patients with Grade II-III osteoarthritis according to the Kellgren Lawrence Classification and a joint width space of 1-3 mm.
- Axial hip, knee, ankle x-ray with no more than 5 degrees valgus/varus deformity
- Medial, lateral or dual compartment OA as determined above
- BMI <35
- Danish speaker
- Patients must be legally competent and must be able to sign the written consent
Exclusion Criteria
- Severe Osteoarthritis (Grade IV according to Kellgren Lavrence Classification)
- Intraarticular tumor, infection or fracture
- Pregnancy and breast feeding
- Cognitive impairment
- Treatment with cytostatic drugs
- Previous intraarticular knee injection in the past 3 mo.
- Unable to perform MRI scan (non-compatible implants, claustrophobia and severe obesity(>BMI 35)
- Previous ligament reconstruction
- Meniscal operation with resection with more than 50% or multiple meniscal operations (more than one resection)
- Diabetes mellitus type 1 and 2
- Knee instability on physical examination
- History of allergy to antibiotics
- Concomitant severe infection, malignant tumor, coagulation diseases or uncontrolled or unmanaged systemic disease
- Presence of other types of inflammatory arthritis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Allogenic adipose derived mesenchymal stem cells (AD-MSC) Single intraarticular knee injection with allogenic adipose derived mesenchymal stem cells (AD-MSC) 20 million AD-MSC in 10 mL saline Control Saline Single intraarticular knee injection with saline alone 10 mL saline
- Primary Outcome Measures
Name Time Method Observation (change) of adverse events Baseline, 3 months, 12 months, 24 months, 3 years, 4 years, 5 years Pain Diary first 30 days after treatment, any reported adverse events after treatment
Change in Knee symptoms (questionnaire Knee injury and Osteoarthritis Outcome Score (KOOS) (symptoms)) from baseline Baseline, 3 months, 12 months, 24 months, 3 years, 4 years, 5 years (questionnaire Knee injury and Osteoarthritis Outcome Score (KOOS) (symptoms))
- Secondary Outcome Measures
Name Time Method Observation (change) of cartilage regeneration compared to baseline Baseline, 3 months, 12 months, 24 months MRI Osteoarthritis Knee Score
Observation (change) of quantitative cartilage regeneration compared to baseline Baseline, 3 months, 12 months, 24 months Quantitative MRI (unit: stress and strain and volumen cartilage)
Improvement (change) during clinical examination with range of motion compared to baseline Baseline, 3 months, 12 months, 24 months Range of motion (unit: degrees)
Change in pain from baseline Baseline, 3 months, 12 months, 24 months, 3 years, 4 years, 5 years Numeric Rating Scale (NRS)
Improvement (change) during clinical examination with Effusion tests (swelling) compared to baseline Baseline, 3 months, 12 months, 24 months Effusion tests (swelling) (unit: effusion (YES/NO))
Improvement (change) during clinical examination with measurement of knee diameter (swelling) compared to baseline Baseline, 3 months, 12 months, 24 months Measure knee diameter (unit: cm)
Improvement (change) during clinical examination with measurement of quadriceps muscle diameter (atrofi) compared to baseline Baseline, 3 months, 12 months, 24 months Measure quadriceps muscle (unit: cm)
Trial Locations
- Locations (1)
Aarhus University
🇩🇰Aarhus N, Denmark