E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients diagnosed with gonarthrosis II, III and IV degrees of Kellgren and Lawrence |
Pacientes diagnosticados de gonartrosis grados II, III y IV de Kellgren y Lawrence |
|
E.1.1.1 | Medical condition in easily understood language |
Patients diagnosed with knee osteoarthritis |
Pacientes diagnosticados con artritis de rodilla |
|
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 | 10023476 |
E.1.2 | Term | Knee osteoarthritis |
E.1.2 | System Organ Class | 100000004859 |
|
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 |
To evaluate the feasibility and safety of the MSV-cryo after cryopreservation process, restoration and recultivation, applied by percutaneous injection in the knee joint, as a treatment for osteoarthritis of the knee, which is realizable by checking each of the procedures in the protocol, including the cost of cell production, and recording any adverse effects related to cellular therapy and that may arise during the duration of the trial, whether or not related there to. |
Evaluar la viabilidad y la seguridad de las MSV-crio tras proceso de criopreservación, restauración y recultivo, aplicadas por inyección percutánea en la articulación de la rodilla, como tratamiento de la artrosis de rodilla, comprobando que es realizable cada uno de los procedimientos establecidos en el protocolo, incluyendo las incidencias de la producción celular, y registrando los posibles efectos adversos relacionados con la terapia celular y los que pudieran surgir durante la duración del ensayo clínico, ya sean o no relacionados con el mismo. |
|
E.2.2 | Secondary objectives of the trial |
To determine the clinical and variations denoting MR images degeneration or, conversely, progression of arthritic process, after 12 months after implantation effected in MSV-cryo the affected joint. |
Determinar los resultados clínicos y las variaciones de las imágenes RM que denoten degeneración o, por el contrario, progresión del proceso artrósico, después de 12 meses de haberse efectuado la implantación de MSV-crio en la articulación afecta. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Gonarthrosis of 2nd, 3rd or 4th degrees of Kellgren and Lawrence (Kellgren & Lawrence, 1957) assessed by two observers.
2. Chronic painful knee mechanical characteristics.
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 de 2º,3º o 4º grados 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 hematológicos y bioquímicos 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> 70 years
3. Previous intervention affected knee
4. Intraarticular treatment in the last 6 months.
5. Infection present (for inclusion in the study should not evidenced any signs infectious).
6. Patients with positive serology for HIV 1 and 2, Hepatitis B (HBsAg, Anti-HCV-Ab), Hepatitis C (Anti-HCV-Ab) and syphilis.
7. Congenital or developmental malformation translate and / or significant deformation of knee problems and condition of application and evaluation of results.
8. Excess weight expressed as body mass index (BMI) greater than 30.5 (obesity grade II). Being BMI = weight (kg): (height (m)) 2.
9. Women who are pregnant or intend to become pregnant, or breastfeeding
10. neoplastic disease
11. United immunosuppressive
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 > 70 años
3. Intervención previa en rodilla afectada
4. Tratamiento intraarticular en los últimos 6 meses.
5. Infección presente (para incluirse en el estudio no debe evidenciarse ningún signo infeccioso).
6. Pacientes que presenten serología positiva frente a HIV 1 y 2, Hepatitis B (HBsAg, Anti-HCV-Ab), Hepatitis C (Anti-HCV-Ab) y Lúes.
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 |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The objective is to evaluate the feasibility and safety of the procedure and the medication by recording adverse events |
El objetivo es la evaluación de la viabilidad y seguridad del procedimiento y del medicamento mediante registro de efectos adversos |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Clinical improvement and cartilage quality assessed by algofuncionales rates, quality of life and image of the trial on schedule. |
Mejoría clínica del paciente y de la calidad del cartílago evaluadas mediante índices algofuncionales, de calidad de vida y de imagen según cronograma del ensayo. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | |
E.8.9.1 | In the Member State concerned months | 18 |
E.8.9.1 | In the Member State concerned days | |