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Enrolling by Invitation

NCT Number: NCT06893250

Orthobiologic Treatment for Knee Osteoarthritis

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.

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Key information

Conditions

Osteoarthritis Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University Hospital in Northern Norway

Tromsø, 9038, Norway

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Symptomatic osteoarthritis in the knee grade I-III using the Kellgren-Lawrance Grading Scale
  • 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

  • Pregnant or breastfeeding women
  • 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

Treatment and study plan

PRP injection

Biological

Platelet rich plasma, blood from the patient that is centrifuged.

Other names: Platelet rich plasma, PRP

ADSTEM Inj. (Adult human mesenchymal stem cells)

Biological

Adipose tissue stem cells, from abdominal fat.

Other names: Mesenchymal stem cells, Adipose tissue stem cells

Injection

Biological

PRP + adipose tissue stem cells

Other names: PRP, Adipose tissue stem cells

Saline (NaCl 0,9 %) (placebo)

Biological

Sterile saline injection.

Other names: placebo, NaCl, saline

Primary outcomes

  1. KOOS (The Knee injury and Osteoarthritis Outcome Score)

    Time frame: Evaluated during 2 years of follow up (6 weeks, 12 weeks, 6 months, 1 year, 2 years)

    KOOS score filled out by the patient, from 0-100 where a higher score indicates worse outcomes.

  2. WOMAC score (Western Ontario og McMaster Universities Osteoarthritis Index)

    Time frame: Evaluated during 2 years of follow up (6 weeks, 12 weeks, 6 months, 1 year, 2 years)

    Clinical outcome scores (WOMAC) filled out by the patient. Scale from 0-96 in total (0-4 on each question, added together). A higher score indicates a worse score.

  3. VAS (Visual analogue scale)

    Time frame: Evaluated during 2 years of follow up (6 weeks, 12 weeks, 6 months, 1 year, 2 years)

    Pain score (VAS) from 0-10 where a higher score indicates worse outcomes.

Secondary outcomes

  1. Radiological findings after treatment

    Time frame: At inclusion and 2 years after intervention.

    Cartilage status on MRI (magnetic resonance imaging) 2 years after intervention as compared with at time of inclusion

Sponsors and collaborators

Lead sponsor

University Hospital of North Norway

Other

Registry information

Official study title

Orthobiologic Treatment for Knee Osteoarthritis (Ortobiologisk Behandling av Kneleddsartrose)

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 25, 2025
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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