Actively Recruiting
Allogenic Mesenchymal Stem Cell Intraarticular Injection for Knee Osteoarthritis Therapy
Led by Aarhus University Hospital · Updated on 2024-06-11
80
Participants Needed
1
Research Sites
342 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Allogenic Mesenchymal Stem Cell Intraarticular Injection for Knee Osteoarthritis Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Chronic knee pain lasting at least 6 months with a pain score of 4 or higher when pain is worst
- Grade II-III knee osteoarthritis according to Kellgren Lawrence Classification with joint space width of 1-3 mm
- Axial hip, knee, ankle X-ray showing no more than 5 degrees valgus or varus deformity
- Osteoarthritis in medial, lateral, or dual compartments
- Body mass index (BMI) less than 35
- Able to speak Danish
- Legally competent and able to sign written consent
You will not qualify if you...
- Severe osteoarthritis (Grade IV according to Kellgren Lawrence Classification)
- Presence of intraarticular tumor, infection, or fracture
- Pregnancy or breastfeeding
- Cognitive impairment
- Treatment with cytostatic drugs
- Intraarticular knee injection within the past 3 months
- Unable to undergo MRI scan due to non-compatible implants, claustrophobia, or BMI over 35
- Previous ligament reconstruction surgery
- Meniscal surgery with more than 50% resection or multiple meniscal resections
- Type 1 or type 2 diabetes mellitus
- Knee instability on physical examination
- History of allergy to antibiotics
- Severe infection, malignant tumor, coagulation disorders, or uncontrolled systemic disease
- Other types of inflammatory arthritis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Aarhus University
Aarhus N, Denmark, 8200
Actively Recruiting
Research Team
R
Rasmus Aabling, MD
CONTACT
M
Michael Pedersen, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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