Clinical Trials Register

Summary
EudraCT Number:	2009-013683-39
Sponsor's Protocol Code Number:	TECAM-PACING
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2009-07-29
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2009-013683-39

A.3

Full title of the trial

?Ensayo clínico de factibilidad, seguridad y eficacia de la terapia de resincronización cardiaca y del transplante intracoronario de células madre mononucleares de medula ósea en pacientes con infarto agudo de miocardio.?

A.4.1

Sponsor's protocol code number

TECAM-PACING

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Fundación para la Investigación Biomédica del Hospital Gregorio Marañón
B.1.3.4	Country	Spain
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Celulas madre de medula osea autologas
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Intracoronary use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	celulas
D.3.9.1	CAS number	Nº PEI 05-42
D.3.9.2	Current sponsor code	Promotor no comercial
D.3.10	Strength
D.3.10.1	Concentration unit	ml millilitre(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	10
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	Information not present in EudraCT

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

La seguridad, factibilidad y eficacia de la terapia celular con trasplante intracoronario de la fracción mononuclear de la médula ósea

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

1) Determinar la seguridad y factibilidad del trasplante intracoronario de células madre de médula ósea, de la estimulación del ventrículo izquierdo y de ambas combinadas, en pacientes con infarto agudo de miocardio y alto riesgo de un remodelado desfavorable postinfarto.
2) Evaluar la eficacia en la prevención del remodelado ventricular desfavorable de las dos terapias y del tratamiento combinado con ambas, en comparación con un grupo de tratamiento estándar.

E.2.2

Secondary objectives of the trial

1) Estudiar el impacto de la terapia celular y/o de la estimulación ventricular izquierda en la función ventricular mediante parámetros ecocardiográficos.
2) Definir marcadores bioquímicos que identifiquen aquellos pacientes susceptibles de padecer un remodelado ventricular desfavorable y como consecuencia insuficiencia cardiaca, e identificar aquellos pacientes que puedan responder a este tipo de terapias.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

? Primer infarto agudo de miocardio anterior con elevación del segmento ST en los últimos 8 días (sumatoria de ST de al menos 6 mm), sin existencia de onda Q en otras localizaciones, en los últimos 8 días.
? Intervención coronaria percutánea en las primeras 24 horas desde el inicio del dolor, o bien trombolisis en las primeras 12 horas seguida de intervención coronaria percutánea en las 24 horas siguientes a la trombolisis.
? Implantación de stent en una arteria coronaria nativa con diámetro de referencia visual ? 2.0 mm y ? 4.5 mm.
? Creatinfosfoquinasa (CPK) ? 2 veces el valor normal en las 72 horas siguientes al infarto.
? Duración del QRS < 130 ms en todos los electrocardiogramas después del infarto.
? Fracción de eyección ? 45% determinada por ecocardiografía después de 72 horas y antes de 8 días desde el inicio del infarto.
? Alteraciones de la contractilidad en al menos 5 segmentos de los 16 posibles (mediante ecocardiografía después de 72 horas y antes de 8 días desde el inicio del infarto)
? Obtención, purificación e implante de las CMMO en los 10 días siguientes al infarto y en las primeras 24 horas tras la extracción de la médula ósea.
? Implante del resincronizador en los 8 días siguientes al infarto.
? Obtención del consentimiento informado.

E.4

Principal exclusion criteria

? Edad: menores de 18 años ó mayores de 80 años.
? Taquiarritmia auricular permanente o persistente en el momento de la inclusión.
? Shock cardiogénico (presión arterial sistólica <90 mmHg con fármacos inotrópicos en los 2 días siguientes a la inclusión.
? Insuficiencia mitral grado 3 o mayor.
? Bloqueo A-V de 2º o 3er grado.
? Paciente tratado previamente o programado para cirugía de revascularización con bypass aortocoronarios.
? Condición médica o adicción a sustancias que impida el seguimiento de la medicación prevista, origine errores de interpretación de los resultados o tenga una expectativa de vida < de 1 año.
? Insuficiencia renal previamente conocida con creatinina > 2.5 mg/dL (190.65 ?mol/L)
? Participante en otro ensayo clínico.
? Portador de marcapasos, desfibrilador o resincronizador.
? Insuficiencia cardiaca en grado funcional IV de la NYHA.
? Paciente en lista de espera de trasplante cardíaco.
? Mujeres en edad fértil a no ser que exista test de embarazo negativo.
? Contraindicación para la aspiración de médula ósea.
? Trasplante de médula ósea previo.
? Radioterapia o quimioterapia previas.

E.5 End points

E.5.1

Primary end point(s)

Determinar la seguridad y factibilidad del trasplante intracoronario de células madre de médula ósea, de la estimulación del ventrículo izquierdo y de ambas técnicas combinadas, en pacientes con infarto agudo de miocardio y alto riesgo de un remodelado desfavorable post-infarto

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

Information not present in EudraCT

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)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Aleatorizado

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.3

The trial involves single site in the Member State concerned

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

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

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

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

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects
F.1 Age Range
F.1.1	Trial has subjects under 18	No
F.1.1.1	In Utero	Information not present in EudraCT
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	Information not present in EudraCT
F.1.1.3	Newborns (0-27 days)	Information not present in EudraCT
F.1.1.4	Infants and toddlers (28 days-23 months)	Information not present in EudraCT
F.1.1.5	Children (2-11years)	Information not present in EudraCT
F.1.1.6	Adolescents (12-17 years)	Information not present in EudraCT
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	Yes
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2009-07-29.	Yes
F.3.3.2	Women of child-bearing potential using contraception	Yes
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	120

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2009-12-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2009-11-10

P. End of Trial
P.	End of Trial Status	Completed

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