Knee osteoarthritis MedDRA version: 21.1 Level: LLT Classification code 10023476 Term: Knee osteoarthritis System Organ Class: 100000004859
Conditions
Interventions
Product Name: Durolane
Pharmaceutical Form: Injection
INN or Proposed INN: Hyaluronc acid
CAS Number: 9004-61-9
Other descriptive name: HYALURONIC ACID
Concentration unit: mg milligram(s)
Concentratio
Sponsors
IBSAL (Instituto de Investigación Biomédica de Salamanca)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Kellgren and Lawrence grade 2, 3 or 4 gonarthrosis. 2. Chronic painful knee of mechanical characteristics. 3. Absence of local or systemic septic process. 4. Hematological and biochemical analysis without significant alterations that contraindicate the treatment. 5. Informed written consent of the patient. 6. The patient is able to understand the nature of the study. 7. NEGATIVE Serologies: RPR, HIV, HBV, HCV and HCV PCR, in the 30 days prior to bone marrow extraction. 8. Body Mass Index 20-35 Kg / m2. 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 80
Exclusion criteria
Exclusion criteria: 1. Patient 75 years. 3. Present infection (to be included in the study, no infectious signs should be evidenced). 4. Congenital or evolutionary diseases that translate malformation and / or significant deformations of the knee (varus <10º; valgus <20º) and condition difficulties of application and evaluation of the results. 5. Weight overload expressed in body mass index (BMI) greater than 30.5 (grade II obesity). Being BMI = mass (Kg): (height (m)) 2. 6. Women who are pregnant or pretend to be pregnant or breastfeeding. 7. Neoplastic disease. 8. Primary or secondary immunosuppression. 9. Intra-articular infiltration of any drug in the 3 months prior to inclusion in the study. 10. Simultaneous participation in another clinical trial or treatment with another product under investigation in the 30 days prior to inclusion in the study. 11. Other pathologies or circumstances that compromise participation in the study according to medical criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate comparatively the efficacy of allogeneic MSCs and autologous MSCs against an active control with hyaluronic acid in terms of clinical-functional and radiological response.;Secondary Objective: • Analyze comparatively changes in the quality of life of patients in the three experimental groups • Confirm the feasibility of the cell treatment of both cell types in a multi-center strategy with various Cell Production Units, analyzing the rate of products that do not comply with the release criteria and the characteristics of the product released and infused. • Collect the rate of adverse effects and other pharmacovigilance parameters in the three treatment branches.;Primary end point(s): Assessment of the clinical-functional and radiological response response based on the following parameters: - Measurement of pain intensity according to the EVA pain scale at 12 months. - Assessment of functional capacity and pain according to the LENESQUE scale at 12 months - Measurement of symptomatology and perceived physical disability according to the WOMAC scale at 12 months. - Estimation of the improvement or stabilization of the lesions in the MR images in T2-mapping at 12 months.;Timepoint(s) of evaluation of this end point: 12 months. Intermediate values will be collected in order to estimate patient evolution at 7 days and 3 and 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Assessment of perceived quality of life on the SF-12 scale at 6 and 12 months. - Rate of products that do not comply with the validation criteria in each branch of experimental treatment. - Rate of adverse effects in each of the treatment branches.;Timepoint(s) of evaluation of this end point: - Día +1 - Día +7 - 3 Meses - 6 Meses - 12 Meses | — |
Countries
Spain
Contacts
Public ContactClinical project manager
SCReN - UICEC CAUSA/IBSAL
Outcome results
None listed