Knee Cartilage Defect MedDRA version: 20.1 Level: PT Classification code 10007710 Term: Cartilage injury System Organ Class: 10022117 - Injury, poisoning and procedural complications MedDRA version: 20.0 Level: PT Classification code 10052913 Term: Cartilage operation System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 20.0 Level: LLT Classification code 10057104 Term: Cartilage repair System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 2
Conditions
Interventions
Product Name: Human autologous mesenchymal stem cells
Product Code: BiCure ortho MSCp
Pharmaceutical Form: Suspension for injection in pre-filled syringe
INN or Proposed INN: Human autologous mesenchy
Sponsors
Bioinova, s.r.o.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 F.1.2.1 Number of subjects for this age range 6 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety of a single dose of autologous MSC seeded on a commercially available acelullar 3D scaffold and fixed by using autologous blood plasma in the repair of knee chondral lesions. ;Secondary Objective: To collect preliminary efficacy data from patient administered questionnaires (VAS, KOOS and Lysholm-Tegner scoring scale) and X-ray. To evaluate feasibility of the treatment in current clinical praxis.;Primary end point(s): •Short-term safety: analysis of adverse events, clinically significant abnormal laboratory values and changes in vital signs and physical examinations •Long-term safety: analysis of adverse events, clinically significant abnormal laboratory values and changes in vital signs and physical examinations •Whole treatment safety: discussion of adverse events potentially occurring after the bone marrow harvest ;Timepoint(s) of evaluation of this end point: •Short-term safety: at 1, 3, 6 and 9 months •Long-term safety: at 12 and 24 months •Whole treatment safety: at the time period before day 0 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Lysholm-Tegner knee function score (compared to pre-treatment values) •KOOS value (compared to pre-treatment values) •Pain according to VAS (compared to pre-treatment values) •X-ray (compared to pre-treatment values) •Evaluation of patient compliance ;Timepoint(s) of evaluation of this end point: •Lysholm-Tegner knee function score, at 6, 12 and 24 months post-operation •KOOS value, at 6, 12 and 24 months post-operation •Pain according to VAS, at 6, 12 and 24 months post-operation •X-ray at 6, 12 and 24 months post-operation (compared to pre-treatment values) •MRI at 12 months post-operation to evaluate the healing status of the treated cartilage defect •Evaluation of patient compliance at all study visits | — |
Countries
Czech Republic
Contacts
Public ContactHeadquarters
Bioinova, s.r.o.
Outcome results
None listed