NCT06893250

Orthobiologic Treatment for Knee Osteoarthritis

Orthobiologic Treatment for Knee Osteoarthritis (Ortobiologisk Behandling av Kneleddsartrose)

• Status: Enrolling By Invitation
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: University Hospital of North Norway · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The goal of this randomized clinical trial is to compare treatment for osteoarthritis in the knee using platelet rich plasma (PRP) or adipose stem cells (ADS). The main questions it aims to answer are: * Will the patients clinically benefit from the treatment, and if so, which treatment is better? * Will there be radiological findings to support this? Participants will be randomized into one of four groups: PRP, ADS, PRP + ADS or placebo treatment (saline) and will be examined and get an X-ray and MRI of the knee taken at inclusion and after 1 and 2 years.

Detailed description

Patients will be randomized into one of four treatment groups and then be followed up at 6 weeks, 12 weeks, 6 months, 1 year and 2 years after intervention. They will fill out scores and be clinically evaluated, as well as radiologically examined at inclusion and at the final check up (x-ray and MRI).

Conditions

• Osteoarthritis Knee

Interventions

Type	Name	Description
BIOLOGICAL	PRP injection	Platelet rich plasma, blood from the patient that is centrifuged.
BIOLOGICAL	ADSTEM Inj. (Adult human mesenchymal stem cells)	Adipose tissue stem cells, from abdominal fat.
BIOLOGICAL	Injection	PRP + adipose tissue stem cells
BIOLOGICAL	Saline (NaCl 0,9 %) (placebo)	Sterile saline injection.

Timeline

• Start date: 2024-09-23
• Primary completion: 2025-12-01
• Completion: 2027-12-01
• First posted: 2025-03-25
• Last updated: 2025-03-25

Locations

1 site across 1 country: Norway