NCT05933434 Allogenic Mesenchymal Stem Cell Intraarticular Injection for Knee Osteoarthritis Therapy
| NCT ID | NCT05933434 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Aarhus University Hospital |
| Condition | Knee Osteoarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-03-07 |
| Primary Completion | 2030-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 80 participants in total. It began in 2024-03-07 with a primary completion date of 2030-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Rasmus Aabling, MD
PRINCIPAL INVESTIGATOR
University of Aarhus
Frequently Asked Questions
Who can join the NCT05933434 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 75 Years, studying Knee Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05933434 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05933434 currently recruiting?
Yes, NCT05933434 is actively recruiting participants. Contact the research team at rasaab@clin.au.dk for enrollment information.
Where is the NCT05933434 trial being conducted?
This trial is being conducted at Aarhus N, Denmark.
Who is sponsoring the NCT05933434 clinical trial?
NCT05933434 is sponsored by Aarhus University Hospital. The principal investigator is Rasmus Aabling, MD at University of Aarhus. The trial plans to enroll 80 participants.