Orthobiologic Treatment for Knee Osteoarthritis
NCT06893250 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 160
Last updated 2025-03-25
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.
Conditions
- Osteoarthritis Knee
Interventions
- 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.
Sponsors & Collaborators
-
University Hospital of North Norway
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- FACTORIAL
Eligibility
- Min Age
- 40 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-09-23
- Primary Completion
- 2025-12-31
- Completion
- 2027-12-31
Countries
- Norway
Study Locations
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