E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Atrophic pseudarthrosis |
Pseudoartrosis atrófica |
|
E.1.1.1 | Medical condition in easily understood language |
Nonunion fracture |
Fractura ósea no consolidada |
|
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 | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10048617 |
E.1.2 | Term | Pseudarthrosis |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
|
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 safety of HC-SVT-1001 and HC-SVT-1002 in the surgical treatment of atrophic nonunion in long bones by recording of adverse events.
- To evaluate the effectiveness by appearance of signs of osseous setting formation at least in 2 out of 3 cortical (tibia) or 3 out of 4 cortical (humerus, femur, cubitus, radius) within 6 months after surgery. |
- Evaluar la seguridad de la utilización de HC-SVT-1001 y de HC-SVT-1002, en el tratamiento quirúrgico de pseudoartrosis atróticas de huesos largos, mediante la cuantificación de acontecimientos adversos registrados a lo largo del estudio.
- Evaluar la eficacia mediante criterios radiográficos determinada por la consolidación de 2 de 3 corticales (tibia) ó 3 de 4 corticales (húmero, cúbito, radio o fémur) en el plazo de 6 meses después de la cirugía. |
|
E.2.2 | Secondary objectives of the trial |
Conduct a comparative statistical analysis that relates fundamental aspects like incidence of adverse effects, complications, healing time, etc. between the 12 patients of this study and the data of 14 consecutive cases of refractory nonunion of long bones that have been treated since 1-9-2009 with 40x106 autologous fat stem adult mesenchymal cells, expanded following GMP procedures of IBGM Valladolid and under AEMPS compassionate use requirements. |
Realizar un análisis estadístico comparativo que relacione aspectos fundamentales como incidencia de efectos adversos, complicaciones, tiempos de curación, etc. entre los 12 pacientes del presente estudio y los datos de 14 casos consecutivos de pseudoartrosis refractaria de huesos largos que han sido tratados desde fecha 1-9-2009 con dosis celulares de 40x106 MSC de médula ósea autóloga, expandidas con procedimientos GMP del IBGM de Valladolid y correspondientes a tratamientos de usos compasivos autorizados y sometidos al control de la AEMPS. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Patients of either sex between 18 and 65 years of age (both inclusive)
2.Diagnosis of atrophic pseudoarthrosis of long bones confirmed radiographically
3.Hematological and biochemical results without significant alterations where a surgery is contraindicated
4.Signed informed consent from the patient
5.The patient is able to understand the nature of the study. |
1. Pacientes entre 18 y 65 años, ambos sexos.
2. Diagnóstico de pseudoartrosis no hipertrófica de hueso largo confirmada radiográficamente
3. Análisis hematológicos y bioquímicos 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. |
|
E.4 | Principal exclusion criteria |
1.Participation in another clinical trial within the 3 months prior to inclusion.
2.Present infection (infection signs that may impact on the evolution of the lesion should not be evidenced)
3.Other lesions which interfere with the body weight load.
4.Known or suspected allergy to Penicillin, Streptomycin, bovine serum and pig products .
5.Open pseudoarthrosis (at the time of inclusion)
6. Pregnant or lactating women
7.Women of childbearing potential not using effective contraception (eg intrauterine device, oral contraceptives, barrier methods of birth control or other deemed appropriate by the investigator)
8. Neoplastic disease
9. Immunosuppressive state
10. Congenital bone diseases (hypophosphatemia), metabolic bone disease associated with primary or secondary hypoparathyroidism.
11. Chronic renal disease.
12.Smoker of more than 15 cigarettes a day.
13. Badly managed diabetes mellitus.
14. Previous therapeutic radiation (5 previous years) of the affected bone.
15. Peripheral arterial disorders.
16. Other conditions or circumstances that compromise the study participation according to medical criteria |
1. Participación en otro ensayo clínico en los 3 meses previos a su inclusión.
2. Infección presente (no debe evidenciarse ningún signo infeccioso con repercusión sobre la evolución de la lesión tratada).
3. Otras lesiones que interfieran con la carga de peso corporal.
4. Alergias conocidas o sospecha a Penicilina, Estreptomicina, sueros bovinos y productos porcinos.
5. Pseudoartrosis abierta (en el momento de la inclusión)
6. Mujeres embarazadas o en periodo de lactancia
7. Mujeres en edad fértil que no utilicen métodos anticonceptivos eficaces (p.ej. dispositivo intrauterino, anticonceptivos orales, métodos de barrera u otro anticonceptivo considerado adecuado por el investigador)
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.Fumador de más de 15 cigarrillos/ día.
13.Diabetes mellitus mal controlada.
14.Radiación terapéutica en el hueso afectado en los últimos 5 años.
15.Trastorno vascular periférico.
16.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) |
To evaluate the effectiveness by mean of radiological methods on the appearance of signs of osseous setting formation within 6 months after surgery. |
El objetivo es la evaluación de la eficacia mediante criterios radiográficos determinada por la aparición de indicios de formación de callo óseo en el plazo de 6 meses después de la cirugía. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Radiographic series performed in pre-surgery and surgery visit and follow-up visits (1 month after surgery and at 3, 4 and 6 months) |
Series radiográficas realizadas en pre-cirugía, cirugía y en las visitas de seguimiento (1 mes post-cirugía y a los 3, 4 y 6 meses) |
|
E.5.2 | Secondary end point(s) |
Conduct a comparative statistical analysis that relates fundamental aspects like incidence of adverse effects, complications, healing time, etc. between the 12 patients of this study and the data of 14 consecutive cases of refractory nonunion of long bones that have been treated since 1-9-2009 with 40x106 autologous fat stem adult mesenchymal cells, expanded following GMP procedures of IBGM Valladolid and under AEMPS compassionate use requirements. |
Realizar un análisis estadístico comparativo que relacione aspectos fundamentales como incidencia de efectos adversos, complicaciones, tiempos de curación, etc. entre los 12 pacientes del presente estudio y los datos de 14 casos consecutivos de pseudoartrosis refractaria de huesos largos que han sido tratados desde fecha 1-9-2009 con dosis celulares de 40x106 MSC de médula ósea autóloga, expandidas con procedimientos GMP del IBGM de Valladolid y correspondientes a tratamientos de usos compasivos autorizados y sometidos al control de la AEMPS. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
End of study |
Al final del estudio |
|
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 | Information not present in EudraCT |
E.8.1.2 | Open | Yes |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 |