Study Results
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Basic Information
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ENROLLING_BY_INVITATION
PHASE2/PHASE3
160 participants
INTERVENTIONAL
2024-09-23
2027-12-31
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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Platelet rich plasma (PRP)
Plasma taken from the patient is centrifuged and isolated before it is injected into the patients knee.
PRP injection
Platelet rich plasma, blood from the patient that is centrifuged.
Adipose tissue stem cells
Adipose tissue is taken from the patients abdominal subcutaneous fat tissue and is injected into the knee.
ADSTEM Inj. (Adult human mesenchymal stem cells)
Adipose tissue stem cells, from abdominal fat.
Platelet rich plasma + adipose tissue stem cells
A combination of platelet rich plasma and adipose tissue stem cells are taken from the patient and injected into the patients knee.
Injection
PRP + adipose tissue stem cells
Placebo (saline)
Saline (NaCl) is injected into the patients knee.
Saline (NaCl 0,9 %) (placebo)
Sterile saline injection.
Interventions
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PRP injection
Platelet rich plasma, blood from the patient that is centrifuged.
ADSTEM Inj. (Adult human mesenchymal stem cells)
Adipose tissue stem cells, from abdominal fat.
Injection
PRP + adipose tissue stem cells
Saline (NaCl 0,9 %) (placebo)
Sterile saline injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 40-70 years
* Minimum VAS 3
* No use of NSAIDs or steroids the last 14 days
* No injections of hyaluronic acid the last three months
* Varus/valgus deformity \<5 degrees as evaluated on x-ray imaging
Exclusion Criteria
* Cancer
* Other etiologies of knee pain (refered pain, pain from the back, dislocated meniscus on MRI, osteoarthritis grade IV using the Kellgren-Lawrance Grading Scale)
* Previous knee surgery on the affected knee
* Secondary osteoarthritis in the knee
* Previous infection in the knee
* Other diseases (rheumatoid arthritis, diabetes, systemic diseases or corticosteroid-demaning disease)
* Patients with a high risk of deep vein thrombosis
* Patients who cannot cooperate/are low compliance (psychiatric disease) or has contraindications for MRI
40 Years
70 Years
ALL
No
Sponsors
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University Hospital of North Norway
OTHER
Responsible Party
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Locations
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University Hospital in Northern Norway
Tromsø, Tromsø, Norway
Countries
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Other Identifiers
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376638
Identifier Type: -
Identifier Source: org_study_id
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