Orthobiologic Treatment for Knee Osteoarthritis

Phase 2

• Conditions: Osteoarthritis Knee
• Interventions: Biological: PRP injection; Biological: ADSTEM Inj. (Adult human mesenchymal stem cells); Biological: Injection; Biological: Saline (NaCl 0,9 %) (placebo)

• Registration Number: NCT06893250
• Lead Sponsor: University Hospital of North Norway

Brief 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.

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 Timeline

• Status Verified: 2024-09
• Study Start: 2024-09-23
• Study First Submitted: 2024-10-02
• Study First Submitted QC: 2025-03-17
• Last Update Submitted: 2025-03-17
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-25
• Primary Completion: 2025-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Platelet rich plasma (PRP)	PRP injection	Plasma taken from the patient is centrifuged and isolated before it is injected into the patients knee.
Adipose tissue stem cells	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	Injection	A combination of platelet rich plasma and adipose tissue stem cells are taken from the patient and injected into the patients knee.
Placebo (saline)	Saline (NaCl 0,9 %) (placebo)	Saline (NaCl) is injected into the patients knee.

Primary Outcome Measures

Name	Time	Method
WOMAC score (Western Ontario og McMaster Universities Osteoarthritis Index)	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)	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.
KOOS (The Knee injury and Osteoarthritis Outcome Score)	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.

Secondary Outcome Measures

Name	Time	Method
Radiological findings after treatment	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

Trial Locations

Locations (1)

University Hospital in Northern Norway; 🇳🇴 Tromso, Tromsø, Norway