Allogenic Mesenchymal Stem Cell Intraarticular Injection for Knee Osteoarthritis Therapy

Recruiting now · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Knee Osteoarthritis

In brief

This phase I and II double blinded randomized clinical controlled trial investigates the safety and efficacy of intraarticular knee injection with allogenic adipose derived mesenchymal stem cells (AD-MSC), in patients suffering from mild-moderate knee osteoarthritis compared to placebo injection with saline.

Key facts

Study ID

NCT05933434

Run by

Aarhus University Hospital

People needed

80

Starts

2024-03-07

Expected to finish

2030-10-01

Last updated by the study team

2024-06-11

Who can join

Age: 40 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Chronic knee pain (defined for at least 6 months with NRS 4 or above when pain worst)
• Patients with Grade II-III osteoarthritis according to the Kellgren Lawrence Classification and a joint width space of 1-3 mm.
• Axial hip, knee, ankle x-ray with no more than 5 degrees valgus/varus deformity
• Medial, lateral or dual compartment OA as determined above
• BMI <35
• Danish speaker
• Patients must be legally competent and must be able to sign the written consent

You may not qualify if…

• Severe Osteoarthritis (Grade IV according to Kellgren Lavrence Classification)
• Intraarticular tumor, infection or fracture
• Pregnancy and breast feeding
• Cognitive impairment
• Treatment with cytostatic drugs
• Previous intraarticular knee injection in the past 3 mo.
• Unable to perform MRI scan (non-compatible implants, claustrophobia and severe obesity(>BMI 35)
• Previous ligament reconstruction
• Meniscal operation with resection with more than 50% or multiple meniscal operations (more than one resection)
• Diabetes mellitus type 1 and 2
• Knee instability on physical examination
• History of allergy to antibiotics
• Concomitant severe infection, malignant tumor, coagulation diseases or uncontrolled or unmanaged systemic disease
• Presence of other types of inflammatory arthritis

Where it is running

• Aarhus University — Aarhus N, Denmark (enrolling)

Full record on ClinicalTrials.gov

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