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Clinical Trials/EUCTR2012-005845-19-ES
EUCTR2012-005845-19-ES
Active, not recruiting
Not Applicable

Transmyocardial Autologous injection of mononuclear Bone-marrow derived stem cells in infants with HYpoplastic left ventricle syndrome: the TABHY study - estudio TABHY

Fundación para la Investigación biomédica del Hopsital Gregorio Marañón0 sitesJune 10, 2013
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ConditionsHypoplastic left ventricle syndromeTherapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypoplastic left ventricle syndrome
Sponsor
Fundación para la Investigación biomédica del Hopsital Gregorio Marañón
Status
Active, not recruiting
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 10, 2013
End Date
TBD
Last Updated
12 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Fundación para la Investigación biomédica del Hopsital Gregorio Marañón

Eligibility Criteria

Inclusion Criteria

  • •Firma del consentimiento informado escrito
  • •?Los pacientes y/o sus representantes legales autorizados ( padres o tutores) deberán otorgar un consentimiento informado escrito y deberán ser capaces de leer y comprender el mismo.
  • •Población del estudio
  • •?Niños o niñas menores de 18 años con síndrome de ventrículo izquierdo hipoplásico
  • •?Supervivientes al nacimiento a la cirugía paliativa de Norwood o sus variantes
  • •?Tener programada cirugía de Glenn o de Fontan
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 8
  • •F.1\.2 Adults (18\-64 years) no
  • •F.1\.2\.1 Number of subjects for this age range

Exclusion Criteria

  • •Excepciones respecto al sexo y situación reproductora
  • •?Mujeres jovenes en edad fértil .
  • •Excepciones respecto a la enfermedad de referencia
  • •?Historia de taquicardia ventricular sostenida ó fibrilación ventricular
  • •Anamnesis y enfermedades concomitantes
  • •?Presentar déficit neurológicos graves tras la cirugía de Norwood
  • •Datos analíticos y datos obtenidos en la exploración física
  • •?Presentar algún trastorno de coagulación grave
  • •?Presentar alguna enfermedad hematológica grave
  • •Terapias y/o medicamentos prohibidos

Outcomes

Primary Outcomes

Not specified

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