Orthobiologic Treatment for Knee Osteoarthritis

University Hospital of North Norway

Status and phase: Invitation-only; Phase 3; Phase 2

Conditions: Osteoarthritis Knee

Treatments: Biological: Saline (NaCl 0,9 %) (placebo); Biological: ADSTEM Inj. (Adult human mesenchymal stem cells); Biological: Injection; Biological: PRP injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06893250

376638

Details and patient eligibility

About

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.

Full 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).

Enrollment: 160 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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160 participants in 4 patient groups, including a placebo group

Platelet rich plasma (PRP)

Active Comparator group

Description:

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

Treatment:

Biological: PRP injection

Adipose tissue stem cells

Active Comparator group

Description:

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

Treatment:

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

Platelet rich plasma + adipose tissue stem cells

Active Comparator group

Description:

A combination of platelet rich plasma and adipose tissue stem cells are taken from the patient and injected into the patients knee.

Treatment:

Biological: Injection

Placebo (saline)

Placebo Comparator group

Description:

Saline (NaCl) is injected into the patients knee.

Treatment:

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