Allogenic mesenchymal stem cell intraarticular injection for knee osteoarthritis therapy, an RCT explorative mode-of-action study

Aarhus University0 sites80 target enrollmentNovember 27, 2023

Overview

No summary available.

Registry

who.int

Start Date

November 27, 2023

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Donor, 1\. Male or female aged 40 to \<75 years, 2\. Chronic knee pain (defined for at least 6 months with NRS 4 or above when pain worst), 3\. Patients with Grade II\-III osteoarthritis according to the Kellgren Lawrence Classification and a joint width space of 1\-3 mm., 4\. Axial hip, knee, ankle x\-ray with no more than 5 degrees valgus/varus deformity, 5\. Medial, lateral or dual compartment OA as determined above, 6\. BMI \<35, 7\. Danish speaker, 8\. Patients must be legally competent and must be able to sign the written consent, 1\. Male or female aged 18\-50 years, 2\. Planned cosmetic operation of excessive fat of abdominal, flank, arm and thigh fat, 3\. BMI 18,5\-30, 4\. Non\-smokers (defined as smoking cessation \>12 weeks), 5\. Operation of at least 30 mL adipose tissue, 6\. Speaks Danish, 7\. Legally competent and able to sign the written consent, Patient

•Donor, 1\. Severe Osteoarthritis (Grade IV according to Kellgren Lavrence Classification), 2\. Intraarticular tumor, infection or fracture, 3\. Pregnancy and breast feeding, 4\. Cognitive impairment, 5\. Treatment with cytostatic drugs, 6\. Previous intraarticular knee injection in the past 3 mo., 7\. Unable to perform MRI scan (non\-compatible implants, claustrophobia and severe obesity (\>BMI 35\), 8\. Previous ligament reconstruction, 9\. Meniscal operation with resection with more than 50% or multiple meniscal operations (more than one resection), 10\. Knee instability on physical examination, 1\. Age \>50 years, 11\. History of allergy to antibiotics, 12\. Diabetes mellitus type 1 or dysregulated type 2 diabetes, 13\. Concomitant severe infection, malignant tumor, coagulation diseases, autoimmune disease or uncontrolled or unmanaged systemic disease, 14\. Presence of other types of inflammatory arthritis, 2\. BMI \>30 or \<18,4, 3\. Known comorbidities: diabetes mellitus Type I and II, infectious diseases (HIV, hepatitis B, hepatitis C or syphilis), cancer, autoimmune disorders, metabolic diseases (hyper and hypothyreosis), metabolic syndrome, 4\. Taking immunosuppressive/immunomodulating medication, 5\. Breastfeeding, 6\. Cognitive impairment, 7\. Active smoker, Patient