E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Surgical Treatment of Non-Hypertrophic Pseudoarthrosis and Complex Fractures of Long Bones |
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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 |
To evaluate safety of TRC use for surgical treatment of Non-Hypertrophic Pseudoarthrosis and Complex Fractures of Long Bones, both efficacy of treatment assessed by presence of evidence of "callo oseo" at 6 month from surgey. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Pseudoartrosis no hipertrófica de huesos largos confirmadas radiográficamente o, Fracturas complejas de huesos largos con pérdida de sustancia y mal pronóstico de consolidación que precisen cirugía con aporte de injerto óseo y que la planificación del tratamiento permita la demora que implica el procesado celular “ex vivo” (fracturas tipo C según clasificación AO). 2. Ausencia de infección en la zona de la fractura 3. Análisis hematológicas y bioquímicas sin alteraciones significativas que contraindiquen la intervención 4. Consentimiento Informado por escrito del paciente. 5. El paciente es capaz de entender la naturaleza del estudio.
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E.4 | Principal exclusion criteria |
1. Paciente < 18 años, o legalmente dependiente 2. Paciente > 65 años 3. Infección presente (para incluirse en el estudio no debe evidenciarse ningún signo infeccioso, inflamación y dolor). 4. Alergias a gentamicina, vancomicina o a sueros bovinos, vacunos o equinos. 5. Pacientes con HIV, Hepatitis, Lues 6. Fractura o Pseudoartrosis abierta (en el tiempo de iniciar el tratamiento) 7. Mujeres embarazadas o en periodo de lactancia 8. Enfermedad neoplásica 9. Estados immunodepresivos 10. Enfermedades congénitas óseas (Hipofosfatemia), enfermedad metabólica ósea asociada con hipoparatiroidismo primario o secundario. 11. Patología renal crónica 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) |
Number of SAEs IMP-related both time in weeks from surgery to presence of evidence of "callo oseo" at 6 month from surgey. |
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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 | 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 | Information not present in EudraCT |
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) | Yes |
E.7.1.1 | First administration to humans | Yes |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
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 | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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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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 | 27 |
E.8.9.1 | In the Member State concerned days | |