Knee Cartilage Defect MedDRA version: 27.0 Level: PT Classification code 10007710 Term: Cartilage injury System Organ Class: 10022117 - Injury, poisoning and procedural complications MedDRA version: 21.1 Level: LLT Classification code 10007705 Term: Cartilage damage System Organ Class: 10022117 - Injury, poisoning and procedural complications MedDRA version: 20.0 Level: LLT Classification code 10057104 Term: Cartilage repair System Organ Class: 10042613 - Surgical and medical procedures MedD
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 mesenc
Sponsors
Bioinova, a.s.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult patients of either sex, age between 18 and 55 years. 2. Confirmed diagnosis of chondral defects of the weight bearing compartment of the knee joint up to the radiologically confirmed knee osteoarthrosis stage II (according to Kellgren classification), the cause of the defect being either trauma or incipient degeneration. 3. Defect is located in the weigh-bearing part of femoral condyle. 4. Scheduled to undergo an open surgery of the knee for the chondral defect management (namely microfracture of the subchondral bone followed by the application of a 3D scaffold). 5. Isolated chondral defect with a maximum size of 6 cm2. 6. No previous knee surgery due to a treatment of a chondral defect. 7. Preoperative level of hemoglobin at least 110 g per L. 8. Preoperative level of platelet count higher than 150 000 per mL. 9. Sexually active, nonsterile female patients need to use highly effective contraception during the whole study. 10. 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 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. 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 planned knee surgery). 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, diabetes and other serious 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. BMI higher than 40. 8. Clinical instability of the knee joint.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy: To compare the treatment efficacy of a combination of conventional microfracture and autologous MSC seeded onto the acellular 3D scaffold as compared to the commonly used method of microfracture and application of the scaffold alone, in subjects with knee joint chondral lesion.;Secondary Objective: Safety: To confirm the safety of autologous MCS administration, as has previously been demonstrated in other orthopaedic indications (rotator cuff, revision hip arthroplasty, posterolateral spinal fusion etc.).;Primary end point(s): 1) Lysholm score (comparison of score changes between the study arms). 2) KOOS value (comparison of score changes between the study arms). 3) Pain according to VAS (comparison of score changes between the study arms). 4) X-ray and MRI evaluation ;Timepoint(s) of evaluation of this end point: 24 months after treatment administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Lysholm-Tegner knee function score 2) KOOS value 3) Pain according to VAS 4) X-ray and MRI evaluation. 5) Adverse event profiles ;Timepoint(s) of evaluation of this end point: 1) Lysholm score, at 3, 6 and 12 months after treatment administration 2) KOOS value, at 3 , 6 and 12 months after treatment administration 3) Pain according to VAS, at 6 weeks, 3, 6 and 12 months after treatment administration 4) Adverse event profiles at 6 weeks, 3, 6, 12 and 24 months after treatment administration 5) X-ray and MRI evaluation at 12 months after treatment administration. | — |
Countries
Czech Republic
Contacts
Public ContactHeadquarters
Bioinova, a.s.
Outcome results
None listed