gonarthrosis (osteoarthritis) MedDRA version: 14.1 Level: LLT Classification code 10048794 Term: Gonarthrosis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: células mesenquimales estromales de médula ósea obtenidas de donantes sanos con serología negativa/MSV/Suspension for injection
Product Name: células mesenquimales estromales de médula óse
Sponsors
Parque Científico de la Universidad de Valladolid
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Gonarthrosis grade 2, 3 or 4 of Kellgren and Lawrence (Kellgren & Lawrence, 1957) assessed by two observers. 2. Chronic painful knee mechanical properties. 3. No local or systemic septic process. 4. Hematological and biochemical analysis without significant alterations that contraindicate treatment. 5. Written informed consent of the patient. 6. The patient is able to understand the nature of the study. 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 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patient 65 years 3. Affected knee prior involvement in 4. Intraarticular treatment in the last 6 months. 5. Ligament disruption MRI image displayed on 6. Infection present (for inclusion in the study should not evidenced any sign infectious). 7. Congenital malformations or evolutionary translate and / or significant deformation of the knee and condition difficulties of implementation and evaluation of results. 8. Excess weight expressed as body mass index (BMI) 30.5 (obesity class II). As BMI = weight (kg): (height (m)) 2 9. Women who are pregnant or intend to become pregnant, or breastfeeding 10. neoplastic disease 11. immunosuppressive states 12. Simultaneous participation in another clinical trial or treatment with another investigational product within 30 days prior to inclusion in the study. 13. Other conditions or circumstances that compromise study participation medically
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the feasibility and safety of allogeneic MSV applied by percutaneous injection in the knee joint as a treatment for osteoarthritis of the knee;Secondary Objective: ? Identify the clinical findings and MRI images changes denoting anti-inflammation, regeneration or, progression of the arthritic, 12 months after inyection of MSV in the affected joint. ? Compare the effectiveness of the two tested treatments in two arms: hialuronic acids.;Primary end point(s): efficacy by clinical criteria;Timepoint(s) of evaluation of this end point: 6 and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Improvement by MRI;Timepoint(s) of evaluation of this end point: 6 and 12 months | — |
Countries
Spain
Contacts
Public ContactCRO
Effice spi S.L.
Outcome results
None listed