Allogenic Mesenchymal Stem Cell Intraarticular Injection for Knee Osteoarthritis Therapy
Recruiting · NCT05933434 · Interventional (participants receive a specific treatment) · Lead sponsor: Aarhus University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Allogenic adipose derived mesenchymal stem cells (AD-MSC)Saline
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.
Who can take part
Age range
40 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Aarhus University - Aarhus N, Denmark