Clinical Trial Results:
Ensayo Clínico Fase II sobre el Efecto de la Infusión Intracoronaria de Células Mononucleadas de Médula Ósea Sobre la Recuperación Funcional en Pacientes con Infarto Crónico Anterior y Depresión Severa de la Función Ventricular Izquierda
Summary
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EudraCT number |
2009-016599-66 |
Trial protocol |
ES |
Global end of trial date |
07 Apr 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
06 Mar 2024
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First version publication date |
06 Mar 2024
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Other versions |
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Summary report(s) |
Final Report_Summary |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
CMMo/CIC/2009
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Fundación Pública Andaluza Progreso y Salud M.P.
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Sponsor organisation address |
Avda. Américo Vespucio 15 · Edificio S-2 · 2ª Pta, Sevilla, Spain, 41092
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Public contact |
ROSARIO CARMEN MATA ALCÁZAR-CABALLERO, Fundación Pública Andaluza Progreso y Salud M.P., rosario.mata@juntadeandalucia.es
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Scientific contact |
ROSARIO CARMEN MATA ALCÁZAR-CABALLERO, Fundación Pública Andaluza Progreso y Salud M.P., rosario.mata@juntadeandalucia.es
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
27 Dec 2022
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
07 Apr 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
07 Apr 2015
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Determinar la eficacia de la inyección intracoronaria de células madre adultas de MO autóloga en pacientes con Infarto de Miocardio Anterior Crónico en términos de mejoría de la función ventricular, determinada por parámetros hemodinámicos, ecocardiográficos y de grado funcional de la NYHA, que se traduce en mejoría de los síntomas de insuficiencia cardiaca y de la calidad de vida del paciente
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Protection of trial subjects |
The trial has been carried out in accordance with the recommendations for Clinical Trials and the evaluation of the product under investigation in humans, which appear in the Declaration of Helsinki,
revised in successive world assemblies (WMA, 2008), and the current Spanish Legislation on Clinical Trials. In addition, the ICH-GPC standards have been followed.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
16 Dec 2010
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Spain: 20
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Worldwide total number of subjects |
20
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EEA total number of subjects |
20
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
20
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||
Pre-assignment
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Screening details |
- | ||||||
Pre-assignment period milestones
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Number of subjects started |
20 | ||||||
Number of subjects completed |
20 | ||||||
Period 1
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Period 1 title |
Recruitment and follow-up (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
Arms
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Arm title
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Group A | ||||||
Arm description |
- | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Unexpanded autologous bone marrow adult mononuclear stem cells
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Infusion
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Routes of administration |
Intracoronary use
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Dosage and administration details |
5 and 7 x 10e8 total cells
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Baseline characteristics reporting groups
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Reporting group title |
Recruitment and follow-up
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Group A
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Reporting group description |
- |
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End point title |
Efficacy [1] | ||||||
End point description |
Determine the efficacy of intracoronary injection of bone marrow progenitor cells autologous in patients with Chronic Anterior Infarction and Heart Failure in the improvement of Ventricular function determined by hemodynamic, clinical and echocardiographic parameters.
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End point type |
Primary
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End point timeframe |
During the study
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: It is detailed in the summary of the clinical report |
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
From the inclusion of the first patient to the last visit of the last patient.
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Assessment type |
Systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
NA
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Frequency threshold for reporting non-serious adverse events: 1% | |||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: It is detailed in the summary of the clinical report |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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18 Jan 2010 |
Change in the planned duration of the study |
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27 Aug 2010 |
Change of exclusion criteria |
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28 Jan 2011 |
A new version of the Sheet is generated Information and Informed Consent for angiography |
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20 Apr 2012 |
The recruitment period is extended to 24 months |
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12 Jun 2013 |
Recruitment period extended |
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16 Dec 2013 |
Recruitment period extended |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |