Clinical trial NCT05933434: Allogenic Mesenchymal Stem Cell Intraarticular Injection for Knee Osteoarthritis Therapy
Official title: Allogenic Mesenchymal Stem Cell Intraarticular Injection for Knee Osteoarthritis Therapy, an RCT Explorative Mode-of-action Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Knee Osteoarthritis
Keywords: allogenic adipose derived mesenchymal stem cells
adipose derived mesenchymal stem cells
mesenchymal stem cells
stem cells
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
First posted: 2023-07-06
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventional group

* Single intraarticular knee injection with allogenic adipose derived mesenchymal stem cells Placebo group
* Single intraarticular knee injection with saline
Primary purpose: TREATMENT

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

Primary outcomes:
measure: Observation (change) of adverse events
timeFrame: Baseline, 3 months, 12 months, 24 months, 3 years, 4 years, 5 years
measure: Change in Knee symptoms (questionnaire Knee injury and Osteoarthritis Outcome Score (KOOS) (symptoms)) from baseline
timeFrame: Baseline, 3 months, 12 months, 24 months, 3 years, 4 years, 5 years
Secondary outcomes:
measure: Change in pain from baseline
timeFrame: Baseline, 3 months, 12 months, 24 months, 3 years, 4 years, 5 years
measure: Observation (change) of cartilage regeneration compared to baseline
timeFrame: Baseline, 3 months, 12 months, 24 months
measure: Observation (change) of quantitative cartilage regeneration compared to baseline
timeFrame: Baseline, 3 months, 12 months, 24 months
measure: Improvement (change) during clinical examination with range of motion compared to baseline
timeFrame: Baseline, 3 months, 12 months, 24 months
measure: Improvement (change) during clinical examination with Effusion tests (swelling) compared to baseline
timeFrame: Baseline, 3 months, 12 months, 24 months
measure: Improvement (change) during clinical examination with measurement of knee diameter (swelling) compared to baseline
timeFrame: Baseline, 3 months, 12 months, 24 months
measure: Improvement (change) during clinical examination with measurement of quadriceps muscle diameter (atrofi) compared to baseline
timeFrame: Baseline, 3 months, 12 months, 24 months
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Aarhus University
Study officials:
affiliation: University of Aarhus
name: Rasmus Aabling, MD
role: PRINCIPAL_INVESTIGATOR
References: