Osteoarthritis KneePhase 2/3NCT06893250
Orthobiologic Treatment for Knee Osteoarthritis
A Phase 2/3 study testing PRP injection, ADSTEM Inj. (Adult human mesenchymal stem cells) and Injection in people with Osteoarthritis Knee, run by University Hospital of North Norway at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Osteoarthritis Knee
- What is being tested?
- PRP injection, ADSTEM Inj. (Adult human mesenchymal stem cells) and Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteNorway
- Study dates
- 23 Sep 2024to Dec 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Orthobiologic Treatment for Knee Osteoarthritis (Ortobiologisk Behandling av Kneleddsartrose)
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).
- Conditions
- Osteoarthritis Knee
- Being tested
- PRP injection, ADSTEM Inj. (Adult human mesenchymal stem cells), Injection, Saline (NaCl 0,9 %) (placebo)
- Keywords
- osteoarthritis, knee, platelet rich plasma, adipose tissue
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRP injectionBiological
Also called Platelet rich plasma, PRP
Platelet rich plasma, blood from the patient that is centrifuged.
ADSTEM Inj. (Adult human mesenchymal stem cells)Biological
Also called Mesenchymal stem cells, Adipose tissue stem cells
Adipose tissue stem cells, from abdominal fat.
InjectionBiological
Also called PRP, Adipose tissue stem cells
PRP + adipose tissue stem cells
Saline (NaCl 0,9 %) (placebo)Biological
Also called placebo, NaCl, saline
Sterile saline injection.
| Study group | Role | What they receive |
|---|---|---|
| Platelet rich plasma (PRP) | Active comparator | Plasma taken from the patient is centrifuged and isolated before it is injected into the patients knee. Receives: Biological: PRP injection |
| Adipose tissue stem cells | Active comparator | Adipose tissue is taken from the patients abdominal subcutaneous fat tissue and is injected into the knee. Receives: Biological: ADSTEM Inj. (Adult human mesenchymal stem cells) |
| Platelet rich plasma + adipose tissue stem cells | Active comparator | A combination of platelet rich plasma and adipose tissue stem cells are taken from the patient and injected into the patients knee. Receives: Biological: Injection |
| Placebo (saline) | Placebo comparator | Saline (NaCl) is injected into the patients knee. Receives: Biological: Saline (NaCl 0,9 %) (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Evaluated during 2 years of follow up (6 weeks, 12 weeks, 6 months, 1 year, 2 years)
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.
Measured: Evaluated during 2 years of follow up (6 weeks, 12 weeks, 6 months, 1 year, 2 years)
VAS (Visual analogue scale)
Pain score (VAS) from 0-10 where a higher score indicates worse outcomes.
Measured: 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
Measured: At inclusion and 2 years after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start23 Sep 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06893250
- Sponsor's protocol ID
- 376638
- Status last verified
- May 2026
- First submitted
- 2 Oct 2024
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only main scientists in the project will have access to IPD.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orthobiologic Treatment for Knee Osteoarthritis (Ortobiologisk Behandling av Kneleddsartrose)
- ClinicalTrials.gov ID
- NCT06893250
- Acronym / sponsor ID
- 376638
- Conditions
- Osteoarthritis Knee
- Keywords
- osteoarthritis, knee, platelet rich plasma, adipose tissue
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 25 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Platelet rich plasma (PRP) | Active comparator | Biological: PRP injectionPlasma taken from the patient is centrifuged and isolated before it is injected into the patients knee. |
| Adipose tissue stem cells | Active comparator | Biological: ADSTEM Inj. (Adult human mesenchymal stem cells)Adipose tissue is taken from the patients abdominal subcutaneous fat tissue and is injected into the knee. |
| Platelet rich plasma + adipose tissue stem cells | Active comparator | Biological: InjectionA combination of platelet rich plasma and adipose tissue stem cells are taken from the patient and injected into the patients knee. |
| Placebo (saline) | Placebo comparator | Biological: Saline (NaCl 0,9 %) (placebo)Saline (NaCl) is injected into the patients knee. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRP injectionAlso: Platelet rich plasma, PRPPlatelet rich plasma, blood from the patient that is centrifuged. | Biological | Platelet rich plasma (PRP) |
| ADSTEM Inj. (Adult human mesenchymal stem cells)Also: Mesenchymal stem cells, Adipose tissue stem cellsAdipose tissue stem cells, from abdominal fat. | Biological | Adipose tissue stem cells |
| InjectionAlso: PRP, Adipose tissue stem cellsPRP + adipose tissue stem cells | Biological | Platelet rich plasma + adipose tissue stem cells |
| Saline (NaCl 0,9 %) (placebo)Also: placebo, NaCl, salineSterile saline injection. | Biological | Placebo (saline) |
Primary outcome
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.
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.
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.
1 secondary outcome
Radiological findings after treatment
Time frame: At inclusion and 2 years after intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No. Only main scientists in the project will have access to IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing PRP injection, ADSTEM Inj. (Adult human mesenchymal stem cells) and Injection in people with Osteoarthritis Knee, run by University Hospital of North Norway at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.