Symptomatic knee articular cartilage defects
Conditions
Interventions
Product Name: NTC chondrograft®
Pharmaceutical Form: Implant
Sponsors
PrimeCell Advanced Therapy a.s.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The patients eligible for this study must fulfill the following criteria at the screening visit: 1. Patient is willing and able to give written informed consent to participate in the study and to actively participate in a follow-up program and designed rehabilitation regimen. 2. Patient is 18 = and = 55 years old at the screening. 3. Patient suffers from symptomatic knee disease with pain subscale score of 4 cm2 = 6cm2 post-debridement for single defect or total defect size > 4 cm2 = 8 cm2 post-debridement for 2 to 3 distinct defects, ? Phase III: up to 3 defects with total defect size = 2 cm2 = 4 cm2 post-debridement (note: the upper limit of the defect size is driven by the efficacy boundaries of the comparator), ? osteochondritis dissecans lesions are included if the bone graft implantation is not requested, ? intact articulating joint surface (no “kissing lesion”). 2. Patient has stable knee joint, i.e. anterior and posterior cruciate ligaments are free of laxity as well as stable and intact. If not, stability of the knee has to be re-established. Ligament repair or reconstruction procedures are allowed concurrent with the treatment surgery. 3. Patient has intact meniscus or partial meniscus with minimally 50% of functional meniscus remaining. Meniscal repair or resection might be performed either prior to or concurrent with NTC chondrograft® implantation if the surgeon presumes that =50% of functional meniscus would remain after the corrective surgery 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 214 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients meeting any of the following criteria will not be eligible for the study treatment: 1. Patient is the investigator or any sub-investigator, study coordinator or other staff, or relative thereof directly involved in the study protocol conduction. 2. Patient who participates in concurrent trials or participated in previous trial within previous 3 months. 3. Patient is unable to undergo magnetic resonance imaging (MRI). 4. Woman who is pregnant or anticipating pregnancy within 3 months following implantation. 5. Patient with a history of surgical treatment of the target knee using mosaicoplasty of microfracture. 6. Patient with history of corrective osteotomy or plastic surgery of patella or crossed ligaments within the last 6 months before screening. 7. Patient who has radiological apparent degenerative joint disease in the target knee, Kellgren-Lawrence Grade 2, 3 or 4 [ 7 ]. 8. Patient with instability of the knee unless it is solved concurrently with the treatment surgery. 9. Patient with total meniscectomy or meniscal allograft or meniscectomy removing >50% of the meniscus in the target knee. 10. Patient with valgus or varus deformity in the target knee. In suspected cases according to a standard X-ray of the affected knee in the supine position, a "long" X-ray picture in p.a. projection will be performed, and in case the axis deviation from the Mikulicz line is 9°, the patient will not be included. 11. Patient with malalignment of patella. 12. Patient with history of chronic inflammatory arthritis or acute infectious arthritis (septic) or osteomyelitis of the target joint. 13. Patient with known systemic connective tissue disease or autoimmune disease. 14. Patient with any clinically significant or symptomatic vascular, muscular or neurologic disorder that would interfere with evaluation of the target knee (i.e. concomitant painful or disabling disease of the spine, hips, or lower limbs). 15. Patient with CRP = 10 mg/l and/or WBC = 10 x 109/l, WBC 35 kg/m2. B. Criteria checked in course of pre-treatment arthroscopy Patients meeting any of the following criteria in course of the index arthroscopy are not eligible for randomization to study treatment: 1. Single defect size out o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is (1) to evaluate, in 18 – 55 years old patients suffering from symptomatic knee articular cartilage defects, whether the implantation of NTC chondrograft® (autologous chondrocytes fixed in fibrin based excipient) is clinically effective, and, if so, (2) whether it is superior to standard procedure, arthroscopic microfracture treatment;Secondary Objective: Not applicable;Primary end point(s): Co-primary endpoint, defined as absolute difference between the final (week 104) and baseline score in multivariate evaluation of Pain and Function-Activities of Daily Living subscales of KOOS.;Timepoint(s) of evaluation of this end point: Co-primary endpoint, defined as absolute difference between the final (week 104) and baseline score in multivariate evaluation of Pain and Function-Activities of Daily Living subscales of KOOS. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change of the MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue) score. In vivo structural repair of the cartilage measured by the absolutchange from 24-week (after NTC chondrograft® Implantation) to 104-week visit assessment of the Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score. • Response rate at Week 104. • Treatment Failure Rate at Week 104. • Subject / Investigator Clinical Global Impression of Change (CGIC). Clinical global impression of change, rated independently by the subject and the investigator • KOOS final value. Final value (week 104 or at premature termination) of the sum of KOOS Pain and Function-Activities of Daily Living. • Change from baseline of each of the KOOS subscale scores and Total Score. Absolute difference between weeks 24, 36, 52, 104 and 156 and baseline score in each of 5 subscales of the KOOS inventory (Pain, Symptoms, QOL, ADL, Function-Activities of Daily Living) and of the KOOS Total Score. • Absolute change of the 2000 IKDC subjective knee evaluation [ 6 ] between assessment at the final week 104 and baseline scores. Tertiary endpoints (exploratory) least 10-point improvement in both the KOOS Pain and KOOS Function-sports scores from baseline to 104-week visit assessment. •Treatment Failure Rate. The proportion (%) of subjects at Week 104 in each treatment group classified as treatment failures. Treatment failure is defined as either a subject’s request for surgical re-treatment of the original index lesion any time after surgery, or no improvement or deterioration of the two subscales of KOOS "Pain" and "Function-sports and recreational activities" between baseline and Week 104 visit assessment, or both. •Subject / Investigator Clinical Global Impression of Change (CGIC). Clinical global impression of change, rated independently by the subject and the investigator •KOOS final value. Final value (week 104 or at premature termination) of the sum o | — |
Countries
Czech Republic
Contacts
Public ContactRNDr. Eva Matejková
Národní centrum Tkání a bunek
Outcome results
None listed