E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Treatment of critical limb ischemia non-revascularization by mesenchymal stem cells. |
TRATAMIENTO DE LA ISQUEMIA CRÍTICA DE MIEMBROS INFERIORES NO REVASCULARIZABLES MEDIANTE CÉLULAS TRONCALES MESENQUIMALES. |
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E.1.1.1 | Medical condition in easily understood language |
Non-revascularizable critical limb ischemia |
Isqueimia crítica no revascularizable |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
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 |
Experimental Drug Safety intramuscular use |
Seguridad del medicamento experimental usado intramuscularmente |
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E.2.2 | Secondary objectives of the trial |
Analyze the limb salvage rate to a year after surgery. Improved arterial vascularization by the ABI tissue oximetry, MRA Quality of life test Pain scale |
Analizar la tasa de salvamento de extremidad a un año del procedimiento. Estudiar variables secundarias de mejora de la vascularización arterial mediante el ITB, oximetría tisular, angiorresonancia magnética Registrar la variación de la calidad de vida de los pacientes mediante cuestionarios y escala analógico-visual del dolor. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Informed Consent. 2. > 18 years. 3. Chronic arterial ischemia grades IV-V of Rutherford that affects at least one limb. 4. Arterial occlusion direct flow or distal femoropopliteal level. 5. No option for surgical or endovascular revascularization. 6. Life expectancy exceeding two years. 7. High probability of need for major amputation at 6 months (CLI nonrevascularizable). 8. Negative pregnancy test if applicable. |
1.Consentimiento Informado. 2.>18 años. 3.Isquemia arterial crónica grados IV-V de Rutherford que afecte al menos a una extremidad. 4.Oclusión de flujo directo arterial a nivel femoropoplíteo o distal. 5.Sin opción quirúrgica o endovascular para la revascularización. 6.Esperanza de vida superior a dos años. 7.Alta probabilidad de necesidad de amputación mayor en 6 meses (Isquemia crítica no revascularizable). 8.Test de embarazo negativo si aplicable. |
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E.4 | Principal exclusion criteria |
1.Background of hematologic neoplasia or unresolved. 2.Hipertensión uncontrolled blood (> 180/110). 3.Severe heart Insuficiencia (New York Heart Association [NYHA] IV) or ejection fraction <30%. 4.ArritmiasMalignant ventricular 5. Venous deep Trombosis the past three months. 6.Active infection. 7.Infarction or stroke the previous three months. 8. Medical or psychiatric illness of any kind which, in the opinion of the investigator, may be a reason for exclusion from the study. 9. Subjects with congenital or acquired immunodeficiencies. Hepatitis B and / or C or tuberculosis diagnosed or treponema at the time of inclusion. 10. Major surgery or severe trauma of the subject in the previous semester. 11. Administration of any investigational drug current or three months prior to enrollment for this trial. 12. Cardiopulmonary disease that in the investigator's opinion, be unstable or is sufficiently serious to rule the patient's study. 13. Infants and pregnant women 14. Adult women of childbearing potential not using contraception effective during the test |
1.Antecedentes de Neoplasia o enfermedad hematológica no resueltas. 2.Hipertensión arterial descontrolada (>180/110). 3.Insuficiencia cardiaca severa (New York Heart Association [NYHA] IV) o fracción de eyección <30%. 4.Arritmias ventriculares malignas. 5.Trombosis venosa profunda los últimos tres meses. 6.Cuadro infeccioso activo. 7.Infarto agudo de miocardio o Accidente cerebrovascular los tres meses previos. 8. Enfermedad médica o psiquiátrica de cualquier tipo que, en opinión del investigador, pueda suponer un motivo de exclusión del estudio. 9. Sujetos con inmunodeficiencias congénitas o adquiridas. Hepatitis B y/o C o tuberculosis diagnosticada en el momento de la inclusión, treponema. 10. Cirugía mayor o traumatismo grave del sujeto en el semestre anterior. 11. Administración de cualquier fármaco en investigación en los tres meses previos a la inclusión en el ensayo 12. Enfermedad cardiopulmonar que, en opinión del investigador, resulte inestable o revista la gravedad suficiente para descartar al paciente del estudio. 13. Lactantes o mujeres embarazadas 14. Mujeres adultas en edad fértil que no utilicen medios anticonceptivos eficaces durante el ensayo |
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E.5 End points |
E.5.1 | Primary end point(s) |
Feasibility and safety of the study will be made once the patient has received treatment at 6 and 12 months after implantation. It defines that the process is safe when in the development and monitoring of the trial there has been no adverse events that may be related to the proposed therapy in the trial. All clinical adverse events during follow-up will be collected at the same times that clinical evaluation. The main objective will be assessed the cumulative incidence of adverse effects attributed to the study therapy. |
Factibilidad y seguridad del estudio se realizará una vez el paciente haya recibido el tratamiento, a los 6 y 12 meses del implante. Se define que el proceso es seguro cuando durante el desarrollo y seguimiento del ensayo no se haya producido ningún acontecimiento adverso que se pueda relacionar con la terapia propuesta en el ensayo. Todos los acontecimientos adversos clínicos serán recogidos durante el seguimiento en los mismos tiempos que la evaluación clínica. Se evaluará como objetivo principal la incidencia acumulada de efectos adversos atribuidos a la terapia en el estudio. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
6 and 12 months |
6 y 12 meses |
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E.5.2 | Secondary end point(s) |
Quality of life of patients and clinical evaluation of the treatment. Test validated generic quality of life (SF-12) and a specific vascular pathology (VASCUQOL), a magnetic resonance angiography records, tissue oximetry and ankle-brachial index. |
Calidad de vida de las pacientes así como una evaluación clínica del tratamiento mediante Test validado de calidad de vida genérico (SF-12) y otro específico de patología vascular (VASCUQOL), una angiorresonancia magnética, registros de oximetría tisular e índice tobillo-brazo. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
6 and 12 months |
6 y 12 meses |
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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 | No |
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 | Yes |
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 | Yes |
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
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Last visit of last recluting patient |
Última visita de seguimiento del último paciente reclutado |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |