Knee Osteoarthritis
Conditions
Keywords
allogenic adipose derived mesenchymal stem cells, adipose derived mesenchymal stem cells, mesenchymal stem cells, stem cells
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.
Interventions
BIOLOGICALAllogenic adipose derived mesenchymal stem cells (AD-MSC)
Laboratory isolated, cultivated and cryopreserved allogenic adipose derived mesenchymal stem cells (AD-MSC) from health donors undergoing cometic plastic surgery will be thawed on the injection day and formulated in 10 mL saline. The AD-MSCs will then be intraarticular injected using ultrasonic guidance.
OTHERSaline
10 mL saline will be intraarticular injected using ultrasonic guidance.
Sponsors
Aarhus University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-blinded (participant and investigator)
Intervention model description
Interventional group * Single intraarticular knee injection with allogenic adipose derived mesenchymal stem cells Placebo group * Single intraarticular knee injection with saline
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Observation (change) of adverse events | Baseline, 3 months, 12 months, 24 months, 3 years, 4 years, 5 years | Pain Diary first 30 days after treatment, any reported adverse events after treatment |
| Change in Knee symptoms (questionnaire Knee injury and Osteoarthritis Outcome Score (KOOS) (symptoms)) from baseline | Baseline, 3 months, 12 months, 24 months, 3 years, 4 years, 5 years | (questionnaire Knee injury and Osteoarthritis Outcome Score (KOOS) (symptoms)) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Observation (change) of quantitative cartilage regeneration compared to baseline | Baseline, 3 months, 12 months, 24 months | Quantitative MRI (unit: stress and strain and volumen cartilage) |
| Improvement (change) during clinical examination with range of motion compared to baseline | Baseline, 3 months, 12 months, 24 months | Range of motion (unit: degrees) |
| Change in pain from baseline | Baseline, 3 months, 12 months, 24 months, 3 years, 4 years, 5 years | Numeric Rating Scale (NRS) |
| Improvement (change) during clinical examination with measurement of knee diameter (swelling) compared to baseline | Baseline, 3 months, 12 months, 24 months | Measure knee diameter (unit: cm) |
| Improvement (change) during clinical examination with measurement of quadriceps muscle diameter (atrofi) compared to baseline | Baseline, 3 months, 12 months, 24 months | Measure quadriceps muscle (unit: cm) |
| Improvement (change) during clinical examination with Effusion tests (swelling) compared to baseline | Baseline, 3 months, 12 months, 24 months | Effusion tests (swelling) (unit: effusion (YES/NO)) |
| Observation (change) of cartilage regeneration compared to baseline | Baseline, 3 months, 12 months, 24 months | MRI Osteoarthritis Knee Score |
Countries
Denmark
Contacts
Primary ContactRasmus Aabling, MD
Backup ContactMichael Pedersen, Professor
Outcome results
None listed