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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Active Comparator | Single intraarticular knee injection with allogenic adipose derived mesenchymal stem cells (AD-MSC) 20 million AD-MSC in 10 mL saline |
|
| Control | Placebo Comparator | Single intraarticular knee injection with saline alone 10 mL saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allogenic adipose derived mesenchymal stem cells (AD-MSC) | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Observation (change) of adverse events | Pain Diary first 30 days after treatment, any reported adverse events after treatment | Baseline, 3 months, 12 months, 24 months, 3 years, 4 years, 5 years |
| Change in Knee symptoms (questionnaire Knee injury and Osteoarthritis Outcome Score (KOOS) (symptoms)) from baseline | (questionnaire Knee injury and Osteoarthritis Outcome Score (KOOS) (symptoms)) | Baseline, 3 months, 12 months, 24 months, 3 years, 4 years, 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain from baseline | Numeric Rating Scale (NRS) | Baseline, 3 months, 12 months, 24 months, 3 years, 4 years, 5 years |
| Observation (change) of cartilage regeneration compared to baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rasmus Aabling, MD | Contact | +4528496767 | rasaab@clin.au.dk | |
| Michael Pedersen, Professor | Contact | michael@clin.au.dk |
| Name | Affiliation | Role |
|---|---|---|
| Rasmus Aabling, MD | University of Aarhus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University | Recruiting | Aarhus N | 8200 | Denmark |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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Interventional group
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Double-blinded (participant and investigator)
|
| Saline | Other | 10 mL saline will be intraarticular injected using ultrasonic guidance. |
|
MRI Osteoarthritis Knee Score
| Baseline, 3 months, 12 months, 24 months |
| Observation (change) of quantitative cartilage regeneration compared to baseline | Quantitative MRI (unit: stress and strain and volumen cartilage) | Baseline, 3 months, 12 months, 24 months |
| Improvement (change) during clinical examination with range of motion compared to baseline | Range of motion (unit: degrees) | Baseline, 3 months, 12 months, 24 months |
| Improvement (change) during clinical examination with Effusion tests (swelling) compared to baseline | Effusion tests (swelling) (unit: effusion (YES/NO)) | Baseline, 3 months, 12 months, 24 months |
| Improvement (change) during clinical examination with measurement of knee diameter (swelling) compared to baseline | Measure knee diameter (unit: cm) | Baseline, 3 months, 12 months, 24 months |
| Improvement (change) during clinical examination with measurement of quadriceps muscle diameter (atrofi) compared to baseline | Measure quadriceps muscle (unit: cm) | Baseline, 3 months, 12 months, 24 months |
| D012216 |
| Rheumatic Diseases |
| D017670 |
| Sodium Compounds |