E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
acute respiratory distress syndrome |
síndrome de distrés respiratorio agudo (SDRA) |
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E.1.1.1 | Medical condition in easily understood language |
acute respiratory distress syndrome |
síndrome de distrés respiratorio agudo (SDRA). |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
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 assess the feasibility, safety and tolerability of the administration of HCR040, a drug whose active substance is HC016, allogeneic adipose-derived adult mesenchymal stem cells expanded and pulsed with H2O2, in patients with acute respiratory distress syndrome. |
Evaluar la viabilidad, seguridad y tolerabilidad de la administración intravenosa de HCR040, un medicamento cuyo principio activo es HC016, células mesenquimales troncales adultas alogénicas de tejido adiposo expandidas y pulsadas con H2O2, en pacientes con síndrome de distrés respiratorio agudo (SDRA). |
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E.2.2 | Secondary objectives of the trial |
To assess the preliminary efficacy of the administration of HCR040, a drug whose active substance is HC016, allogeneic adipose-derived adult mesenchymal stem cells expanded and pulsed with H2O2, in patients with acute respiratory distress syndrome. |
Evaluar la eficacia preliminar de la administración de HCR040, medicamento cuya sustancia activa es HC016, células troncales mesenquimales adultas alogénicas de tejido adiposo expandidas y pulsadas con H2O2, en pacientes con síndrome de distrés respiratorio agudo |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
– Men and women ≥ 18 years – Patients with criteria of moderate to severe ARDS according to the Berlin Conference. – Patients with invasive mechanical ventilation |
- Hombres y mujeres ≥ 18 años - Pacientes con criterios de SDRA moderados a graves según la Conferencia de Berlín. - Pacientes con ventilación mecánica invasiva.
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E.4 | Principal exclusion criteria |
– Participation in a previous clinical study within 28 days prior to the ARDS situation. – Administration of a previous cell therapy product in the 5 years prior to this ARDS clinical situation. – Inability to obtain Informed Consent. |
• Participación en alguna investigación clínica dentro de los 28 días previos a la situación de SDRA . • Administración de un producto de terapia celular en los 5 años anteriores a esta situación clínica. • Imposibilidad de obtener el Consentimiento Informado. |
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E.5 End points |
E.5.1 | Primary end point(s) |
– Adverse events – Average stay in the ICU – SOFA index – Mechanical ventilation |
- Acontecimientos adversos - Estancia media en UCI - Indice SOFA - Ventilación mecánica |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
7, 14, 21, 28, 90, 120 and 365 post-administratión. |
7, 14, 21, 28, 90, 120 y 365días post-administración. |
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E.5.2 | Secondary end point(s) |
– Daily pulmonary mechanics – Determination of lung damage – Days free of vasopressors |
Mecánica pulmonar diaria. Determinación del daño pulmonar Días libres de vasopresores.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
7, 14, 21, 28, 90, 120 y 365 post-administration. |
7, 14, 21, 28, 90, 120 y 365 días post-administración. |
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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 | No |
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) | Yes |
E.7.1.1 | First administration to humans | Yes |
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 | 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 | Yes |
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
| 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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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 | |
E.8.9.1 | In the Member State concerned days | |