Autologous bone marrow-derived mesenchymal stem cells seeded on a 3D scaffold in treatment of knee cartilage defects. Prospective open-label study to assess safety and feasibility.

Bioinova, s.r.o.0 sites6 target enrollmentNovember 12, 2018

Overview

No summary available.

Registry

who.int

Start Date

November 12, 2018

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\.Adult patients of either sex, age between 18 and 60 years.
•2\.Confirmed diagnosis of chondral defects of the weight bearing compartment of the knee joint up to the radiologically confirmed knee osteoarthrosis stage III, the cause of the defect being either trauma or progressive degeneration.
•3\.Scheduled to undergo an open surgery of the knee for the chondral defect management (namely microfracture followed by the application of the 3D scaffold chondrotissue®).
•4\.No previous knee surgery due to a chondral defect.
•5\.Preoperative level of haemoglobin at least 110 g per L.
•6\.Preoperative level of platelet count higher than 150 000 per mL.
•7\.Able to provide written informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

•1\.Ligament laxity or axial deformities over 10° on the study knee.
•2\.Systemic corticosteroid or immunosuppressive medication, or anticoagulant therapy, ongoing or recent, (used regularly during the last 3 months before the screening visit). Intraarticular corticosteroid medication is not allowed within the same time period.
•3\.Active infection or any other condition limiting the healing (e.g., immunodeficiency, hepatitis, active tuberculosis, neoplasm, metabolic disorders, drug abuse, etc.).
•4\.Concurrent or previous cancer.
•5\.Blood, plasma or platelet transfusion during previous 8 weeks.
•6\.Pregnant or lactating women.
•7\.Subject not using two reliable methods method of birth control.
•8\.BMI higher than 40\.
•9\.Clinical instability of the joint objectified during the surgery.