Allogenic Mesenchymal Stem Cell Intraarticular Injection for Knee Osteoarthritis Therapy
Key facts
- Where
- Aarhus C, DenmarkSee the site
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 75 years old?
Source: NCT05933434, who can take part
Where in Denmark
- Aarhus UniversitetAarhus C, DenmarkNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Aarhus University Hospital
- Trial code
- NCT05933434EU 2023-506088-33-01
- Record updated
- 11 June 2024
- Original description
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.Read full original descriptionShow less
Allogenic Mesenchymal Stem Cell Intraarticular Injection for Knee Osteoarthritis Therapy, an RCT Explorative Mode-of-action Study
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.
Inclusion: 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: 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); Concomitant severe infection, malignant tumor, coagulation diseases or uncontrolled or unmanaged systemic disease; Intraarticular tumor, infection or fracture; Cognitive impairment; Diabetes mellitus type 1 and 2; History of allergy to antibiotics; Severe Osteoarthritis (Grade IV according to Kellgren Lavrence Classification); Pregnancy and breast feeding; Knee instability on physical examination; Presence of other types of inflammatory arthritis.