E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
gonarthrosis (osteoarthritis) |
gonartrosis |
|
E.1.1.1 | Medical condition in easily understood language |
gonarthrosis (osteoarthritis) |
gonartrosis |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10048794 |
E.1.2 | Term | Gonarthrosis |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Evaluate the feasibility and safety of allogeneic MSV applied by percutaneous injection in the knee joint as a treatment for osteoarthritis of the knee |
Evaluar la viabilidad y la seguridad de las MSV alogénicas, aplicadas por inyección percutánea en la articulación de la rodilla, como tratamiento de la artrosis de rodilla |
|
E.2.2 | Secondary objectives of the trial |
? 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. |
? Determinar los resultados clínicos y las variaciones de las imágenes RM que denoten antiinflamación, regeneración o, por el contrario, progresión del proceso artrósico, después de 12 meses de haberse efectuado la implantación de MSV en la articulación afecta. ? Comparar la eficacia de las dos variantes del tratamiento testadas en los dos brazos, acido hialurónico |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
1. Gonartrosis grado 2, 3 o 4 de Kellgren y Lawrence (Kellgren & Lawrence, 1957) valorada por dos observadores. 2. Rodilla dolorosa crónica de características mecánicas. 3. Ausencia de proceso séptico local o sistémico. 4. Análisis hematológicas y bioquímicas sin alteraciones significativas que contraindiquen el tratamiento. 5. Consentimiento informado por escrito del paciente. 6. El paciente es capaz de entender la naturaleza del estudio. |
|
E.4 | Principal exclusion criteria |
1. Patient <18 years, or legally dependent 2. 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 |
1. Paciente < 18 años, o legalmente dependiente 2. Paciente > 65 años 3. Intervención previa en rodilla afectada 4. Tratamiento intraarticular en los últimos 6 meses. 5. Rotura ligamentosa visualizada en imagen de RM 6. Infección presente (para incluirse en el estudio no debe evidenciarse ningún signo infeccioso). 7. Enfermedades congénitas o evolutivas que traduzcan malformación y/o deformaciones significativas de la rodilla y condicionen dificultades de aplicación y de evaluación de los resultados. 8. Sobrecarga ponderal expresada en índice de masa corporal (IMC) superior a 30,5 (obesidad grado II). Siendo IMC= masa (Kg): (altura (m))2 9. Mujeres embarazadas o que pretenden estarlo, o en periodo de lactancia 10. Enfermedad neoplásica 11. Estados inmunodepresivos 12. Participación simultánea en otro ensayo clínico o tratamiento con otro producto en fase de Investigación en los 30 días previos a la inclusión en el estudio. 13. Otras patologías o circunstancias que comprometan la participación en el estudio según criterio médico |
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E.5 End points |
E.5.1 | Primary end point(s) |
efficacy by clinical criteria |
eficacia mediante criterios clínicos |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
6 and 12 months |
6 y 12 meses |
|
E.5.2 | Secondary end point(s) |
Improvement by MRI |
Mejora por RM |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
6 and 12 months |
6 y 12 meses |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |