Clinical Trials Register

Summary
EudraCT Number:	2012-000292-16
Sponsor's Protocol Code Number:	HULPTOR-2011-01
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2013-04-09
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

2012-000292-16

A.3

Full title of the trial

Phase IIa clinical trial to test the feasibility and safety of using autologous mesenchymal stem cells from fat in the local treatment of bronchopleural fistula

Ensayo clínico Fase IIa para comprobar la factibilidad y seguridad del uso de células TRONCALES MESENQUIMALES autólogas derivadas de la grasa en el tratamiento local de la fístula broncopleuraL

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Local treatment of bronchopleural fistula with adilts stem cells

Tratamiento local de las fístulas bronquiales con células madre adultas

A.3.2

Name or abbreviated title of the trial where available

HULPTOR

A.4.1

Sponsor's protocol code number

HULPTOR-2011-01

A.7

Trial is part of a Paediatric Investigation Plan

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 Universitario La Paz (FIBHULP)
B.1.3.4	Country	Spain
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Health Ministery
B.4.2	Country	Spain
B.4.1	Name of organisation providing support	FIBHULP
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	FIBHULP
B.5.2	Functional name of contact point	Assignee. Dr. Mariano García Arranz
B.5.3	Address:
B.5.3.1	Street Address	Edif. Laboratorios. Paseo de la Castellana 261
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28046
B.5.3.4	Country	Spain
B.5.4	Telephone number	0034912071022
B.5.5	Fax number	0034917277524
B.5.6	E-mail	mariano.garcia@salud.madrid.org

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	Adipose Derived Stem cells
D.3.2	Product code	eASC
D.3.4	Pharmaceutical form	Implantation suspension
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intratracheal use (Noncurrent) Intralesional use Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ADSC
D.3.9.3	Other descriptive name	EXPANDED HUMAN AUTOLOGOUS MESENCHYMAL ADULT STEM CELLS EXTRACTED FROM ADIPOSE TISSUE (EASCS)
D.3.9.4	EV Substance Code	SUB30158
D.3.10	Strength
D.3.10.1	Concentration unit	million IU million international units
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	40
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)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Yes
D.3.11.3.1	Somatic cell therapy medicinal product	Yes
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
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	No
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	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
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	Yes
D.2.1.1.1	Trade name	Fibrin Sealant Kit
D.2.1.1.2	Name of the Marketing Authorisation holder	Tissucol duo
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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.3.4	Pharmaceutical form	Solution for injection in pre-filled syringe
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Endotracheopulmonary use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Fibrinogeno
D.3.9.1	CAS number	106717-56-0
D.3.9.3	Other descriptive name	FIBRIN SEALANT KIT
D.3.9.4	EV Substance Code	SUB11969MIG
D.3.10	Strength
D.3.10.1	Concentration unit	ml millilitre(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
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)	No
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	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
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	No
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	No

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

Bronchopleural fistula

Fístula broncopleural

E.1.1.1

Medical condition in easily understood language

Bronchopleural fistula is an anormal communication between mucosa of brochial tree and pleural space

La Fístula broncopleural es una comunicación anormal entre el árbol bronquial y el espacio pleural

E.1.1.2

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

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

To evaluate the feasibility and safety of ASC in the treatment of fistulas bronchopleural

Evaluar la factibilidad y seguridad de las ASC en el tratamiento de las fístulas broncopleurales

E.2.2

Secondary objectives of the trial

Obtain preliminary data on the effectiveness and cost of the proposed treatment with mesenchymal stem cells.

Secondary variables studied quality of life through quality of life questionnaires (SF-12)

Obtener datos preliminares de la efectividad y coste del tratamiento propuesto con células troncales mesenquimales.

Estudiar variables secundarias de calidad de vida mediante cuestionarios de calidad de vida (SF-12)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Being over 18 years
2 Having accessible bronchopleural fistula pathology endoscopic approach.
3. Prior control of the fistula with the usual techniques ((pleural drainage, infection control, open thoracostomy and / or endotracheal prosthesis-bronchial)
4. Fistula refracted to conventional medical or surgical treatment.
5. Have signed the informed consent
6. Negative pregnancy test and acceptance of the use of highly effective contraceptive methods if applicable.

1. Ser mayor de 18 años
2. Tener patología fistulosa broncopleural accesible al abordaje endoscópico.
3. Control previo de la fístula con las técnicas habituales ((drenaje pleural, control de la infección, toracostomía abierta y/o prótesis endotraqueo-bronquial)
4. Fístula refractara al tratamiento médico o quirúrgico convencional.
5. Haber firmado el consentimiento informado
6. Test de embarazo negativo y aceptación del uso de métodos anticonceptivos altamente eficaces si aplicable.

E.4

Principal exclusion criteria

1. Mental retardation incapacitating signing the informed consent.
2. Urgency in treatment.
3. Pleural cavity with uncontrolled infection.
4. Extreme malnutrition (BMI <18.5 kg/m2) who advise against liposuction.
5. Presence of uncontrolled malignancy or progression phase.
6. Inability to tolerate the anesthetic and / or bronchoscopic implant required for ASC.
7. Administration of any investigational drug at present to three months prior to enrollment for this trial.
8. Infants and pregnant women.
9. Adult women of childbearing age not using effective contraception as ICH guidance M3 EMA during the test.

1. Retraso mental que le incapacite para la firma del consentimiento informado.
2. Urgencia en el tratamiento.
3. Cavidad pleural con infección no controlada.
4. Desnutrición extrema (IMC<18,5 Kg/m2) que desaconseje la liposucción.
5. Presencia de neoplasia no controlada o en fase de progresión.
6. Imposibilidad de tolerar el procedimiento anestésico y/o broncoscópico requeridos para el implante de ASC.
7. Administración de cualquier fármaco en investigación en el momento actual o tres meses antes del reclutamiento para este ensayo.
8. Lactantes o mujeres embarazadas.
9. Mujeres adultas en edad fértil que no utilicen medios anticonceptivos eficaces según la guía ICH M3 de la EMA durante el ensayo.

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint of safety and feasibility study will be done when the patient has received treatment at 3 and 6 months after implantation. It defines that the process is safe when in the development and monitoring of the trial there has been no adverse events that may be related to the proposed therapy in the trial. All adverse clinical events during follow-up will be collected at the same times as the clinical evaluation. The main objective will be assessed the cumulative incidence of adverse events attributed to study therapy. The primary endpoint last patient will be followed by the research team to 3 years

La variable primaria de factibilidad y seguridad del estudio se realizará una vez el paciente haya recibido el tratamiento, a los 3 y 6 meses del implante. Se define que el proceso es seguro cuando durante el desarrollo y seguimiento del ensayo no se haya producido ningún acontecimiento adverso que se pueda relacionar con la terapia propuesta en el ensayo. Todos los acontecimientos clínicos adversos serán recogidos durante el seguimiento en los mismos tiempos que la evaluación clínica. Se evaluará como objetivo principal la incidencia acumulada de efectos adversos atribuidos a la terapia en estudio. El paciente una vez alcanzada la variable primaria será seguidop por el equipo investigador hasta los 3 años

E.5.1.1

Timepoint(s) of evaluation of this end point

3 and 6 months.
The primary endpoint last patient will be followed by the research team to 3 years

3 y 6 meses.
Los pacientes tendrán un seguimiento por el equipo investigador hasta los 3 años

E.5.2

Secondary end point(s)

Secondary endpoint: As part of the evaluation of the quality of life of patients and clinical assessment of treatment will be at 3 and 6 months after implantation a Test SF-12 quality of life.

Variable secundaria: Como parte de la evaluación de la calidad de vida de los pacientes, así como la evaluación clínica del tratamiento se realizará a los 3 y 6 meses tras el implante un Test SF-12 de calidad de vida.

E.5.2.1

Timepoint(s) of evaluation of this end point

3-6 months

3-6 meses

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

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

E.7.1.2

Bioequivalence study

E.7.1.3

Other

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

E.8.1.1

Randomised

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

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

Yes

E.8.4

The trial involves multiple sites in the 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

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

It is considered achieved when the end points of the trial last visit the patient has improved their quality of life (SF-12 test) and there has been no adverse effects. It will also be valued positively a partial or total closure of the fistula

Se considera alcanzados los end points cuando en la última visita del ensayo el paciente ha mejorado su calidad de vida (test SF-12)y no se haya producido ningún efecto adverso. Además será valorado positivamente un cierre parcial o total del trayecto fistuloso

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

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Semiannual monitoring of patients up to 3 years

Segtuimiento semestral de los pacientes hasta los 3 años

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

2013-06-28

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-03-20

P. End of Trial
P.	End of Trial Status	Ongoing

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