Allogenic Mesenchymal Stem Cell Intraarticular Injection for Knee Osteoarthritis Therapy
NCT ID: NCT05933434
Last Updated: 2024-06-11
Study Results
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Basic Information
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RECRUITING
PHASE1/PHASE2
80 participants
INTERVENTIONAL
2024-03-07
2030-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
* Single intraarticular knee injection with allogenic adipose derived mesenchymal stem cells Placebo group
* Single intraarticular knee injection with saline
TREATMENT
DOUBLE
Study Groups
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Intervention
Single intraarticular knee injection with allogenic adipose derived mesenchymal stem cells (AD-MSC)
20 million AD-MSC in 10 mL saline
Allogenic 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.
Control
Single intraarticular knee injection with saline alone
10 mL saline
Saline
10 mL saline will be intraarticular injected using ultrasonic guidance.
Interventions
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Allogenic 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.
Saline
10 mL saline will be intraarticular injected using ultrasonic guidance.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
75 Years
ALL
No
Sponsors
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Aarhus University Hospital
OTHER
Responsible Party
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Rasmus Roost Aabling
MD
Principal Investigators
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Rasmus Aabling, MD
Role: PRINCIPAL_INVESTIGATOR
University of Aarhus
Locations
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Aarhus University
Aarhus N, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STEMJOINT01
Identifier Type: -
Identifier Source: org_study_id
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