Orthobiologic Treatment for Knee Osteoarthritis

NCT06893250 | Enrolling By Invitation Phase 2

• 1 other identifier: 376638
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis Knee

Keywords

osteoarthritis; knee; platelet rich plasma; adipose tissue

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

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

Secondary Outcomes (1)

• Radiological findings after treatment

  At inclusion and 2 years after intervention.

Study Arms (4)

Platelet rich plasma (PRP)

ACTIVE COMPARATOR

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

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.

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.

Biological: Injection

Placebo (saline)

PLACEBO COMPARATOR

Saline (NaCl) is injected into the patients knee.

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

Interventions

PRP injection BIOLOGICAL

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

Also known as: Platelet rich plasma, PRP

Platelet rich plasma (PRP)

ADSTEM Inj. (Adult human mesenchymal stem cells) BIOLOGICAL

Adipose tissue stem cells, from abdominal fat.

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

Adipose tissue stem cells

Injection BIOLOGICAL

PRP + adipose tissue stem cells

Also known as: PRP, Adipose tissue stem cells

Platelet rich plasma + adipose tissue stem cells

Saline (NaCl 0,9 %) (placebo) BIOLOGICAL

Sterile saline injection.

Also known as: placebo, NaCl, saline

Placebo (saline)

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital of North Norway: lead

Study Sites (1)

University Hospital in Northern Norway

Tromsø, Tromsø, 9038, Norway

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Injections; Sodium Chloride

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2024
• First Posted: March 25, 2025
• Study Start: September 23, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 25, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)