ClinicalTrials.gg
Enrolling by invitationNCT06893250Updated Jun 15, 2026

Orthobiologic Treatment for Knee Osteoarthritis

A Phase 2/3 interventional study of PRP injection and ADSTEM Inj. (Adult human mesenchymal stem cells) in Osteoarthritis Knee, sponsored by University Hospital of North Norway. Enrolling by invitation at 1 site in Norway. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-06-15.

Sponsored by University Hospital of North Norway · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
40 Years to 70 Years
Sex
All
01

Study 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.
Read the 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).

02

Conditions studied

  • Osteoarthritis Knee

Keywords

  • osteoarthritis
  • knee
  • platelet rich plasma
  • adipose tissue
03

In context

Osteoarthritis, Knee

3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.

This study's planned enrollment of 160 is above the median of 68 across 2,714 interventional studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

University Hospital of North Norway is the lead sponsor of 152 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

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 -demaning disease)
  • Patients with a high risk of deep vein thrombosis
  • Patients who cannot cooperate/are low compliance (psychiatric disease) or has for MRI
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
160 participants (estimated)

Study arms

  • Active comparator
    Platelet rich plasma (PRP)

    Plasma taken from the patient is centrifuged and isolated before it is injected into the patients knee.

    Biological: PRP injection

  • Active comparator
    Adipose tissue stem cells

    Adipose tissue is taken from the patients abdominal subcutaneous fat tissue and is injected into the knee.

    Biological: ADSTEM Inj. (Adult human mesenchymal stem cells)

  • Active comparator
    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.

    Biological: Injection

  • Placebo comparator
    Placebo (saline)

    Saline (NaCl) is injected into the patients knee.

    Biological: Saline (NaCl 0,9 %) (placebo)

Interventions

  • BiologicalPRP injection

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

    Also known as: Platelet rich plasma, PRP

  • BiologicalADSTEM Inj. (Adult human mesenchymal stem cells)

    Adipose tissue stem cells, from abdominal fat.

    Also known as: Mesenchymal stem cells, Adipose tissue stem cells

  • BiologicalInjection

    PRP + adipose tissue stem cells

    Also known as: PRP, Adipose tissue stem cells

  • BiologicalSaline (NaCl 0,9 %) (placebo)

    Sterile saline injection.

    Also known as: placebo, NaCl, saline

06

What researchers measure

Primary outcomes

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

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

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

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

    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.

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

  3. VAS (Visual analogue scale)

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

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

Secondary outcomes

  1. Radiological findings after treatment

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

    Time frame: At inclusion and 2 years after intervention.

07

Study locations

1 site
  • University Hospital in Northern Norway
    Tromsø, Tromsø 9038, Norway
08

References and documents

Individual participant data

Plan to share: No — Only main scientists in the project will have access to IPD.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06893250
Responsible party
Sponsor
First posted
Mar 25, 2025
Start date
Sep 23, 2024
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Jun 15, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Platelet rich plasma

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