Injections of stem cells for treating knee osteoarthritis

Allogenic Mesenchymal Stem Cell Intraarticular Injection for Knee Osteoarthritis Therapy, an RCT Explorative Mode-of-action Study

This study is testing if injections of stem cells can help people with mild to moderate knee osteoarthritis feel less pain and move better compared to a placebo injection.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 40 Years to 75 Years
• Sex: All
• Sponsor: Aarhus University Hospital (other)
• Locations: 1 site (Aarhus N)
• Trial ID: NCT05933434 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are Danish-speaking adults with chronic knee pain and Grade II-III osteoarthritis.

Not a fit: Patients with severe osteoarthritis or those who have had recent knee injections or surgeries may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new, effective option for patients suffering from knee osteoarthritis, potentially reducing pain and improving mobility.

How similar studies have performed: Previous studies have shown promise in using stem cells for joint therapy, but this specific approach is still being evaluated for its efficacy.

Eligibility criteria

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 this trial is running

Aarhus N

• Aarhus University — Aarhus N, Denmark (RECRUITING)

Study contacts

• Principal investigator: Rasmus Aabling, MD — University of Aarhus
• Study coordinator: Rasmus Aabling, MD

Conditions: Knee Osteoarthritis, allogenic adipose derived mesenchymal stem cells, adipose derived mesenchymal stem cells, mesenchymal stem cells, stem cells