Injections of stem cells for treating knee osteoarthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and effectiveness of injecting allogenic adipose-derived mesenchymal stem cells (AD-MSC) into the knee joint of patients with mild to moderate knee osteoarthritis. Participants will be randomly assigned to receive either the stem cell injection or a placebo saline injection. The study aims to determine if the stem cell treatment can alleviate chronic knee pain and improve joint function compared to the placebo. It is a double-blinded trial, ensuring that neither the participants nor the researchers know who receives which treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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's running

• Aarhus University
  Aarhus N, Denmark Recruiting

Study contacts

• Principal investigator: Rasmus Aabling, MD — University of Aarhus
• Study coordinator: Rasmus Aabling, MD
• Email: rasaab@clin.au.dk
• Phone: +4528496767

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.