Clinical Trials Register

Summary
EudraCT Number:	2010-024331-16
Sponsor's Protocol Code Number:	HULPURO-2010-01
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:	2011-12-12
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

2010-024331-16

A.3

Full title of the trial

Clinical trial phase II to determine the feasibility and safety of using autologous mesenchymal stem cells derived from autologous expanded adipose tissue (ASC) in the local treatment of female urinary incontinence due to strain

Ensayo clínico individual en fase II para conocer la factibilidad y seguridad del uso autólogo de células troncales mesenquimales autólogas derivadas del tejido adiposo expandidas (ASC) en el tratamiento local de incontinencia urinaria femenina por esfuerzo

A.3.1

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

The proposal is to join a Phase II clinical trial to test the feasibility and safety of a new therapeutic application based on the use of mesenchymal stem cells derived from adipose tissue (ASC) that is being made in various international hospitals.

Se le propone incorporarse a un Ensayo Clínico en Fase II para comprobar la factibilidad y seguridad de una nueva aplicación terapéutica basada en el uso de células troncales mesenquimales derivadas del tejido adiposo (ASC) que se está realizando en diversos hospitales internacionales.

A.3.2

Name or abbreviated title of the trial where available

HULPURO-2010-01

A.4.1

Sponsor's protocol code number

HULPURO-2010-01

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
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	Ministerio de Sanidad, Política Social e
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	Fundación para la Investigación Biomédica del Hospital
B.5.2	Functional name of contact point	Unidad de Terapia Celular
B.5.3	Address:
B.5.3.1	Street Address	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	0034912071512
B.5.6	E-mail	mgarciaa.hulp@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	Células troncales mesenquimales autólogas derivadas de tejido adiposo expandidas (ASC)
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intralesional use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Células troncales mesenquimales autólogas derivadas de tejido adiposo expandidas (ASC)
D.3.9.3	Other descriptive name	Células troncales mesenquimales autólogas derivadas de tejido adiposo expandidas (ASC)
D.3.10	Strength
D.3.10.1	Concentration unit	Other
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)	Yes
	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.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

Urinary incontinence in women due to strain.

Incontinencia urinaria por esfuerzo en la mujer.

E.1.1.1

Medical condition in easily understood language

Urinary incontinence in women due to strain.

Incontinencia urinaria por esfuerzo en la mujer.

E.1.1.2

Therapeutic area

Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

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

Evaluate the safety of ASC to treat urinary incontinence in women due to strain.

Evaluar la seguridad de las ASC para tratar la incontinencia urinaria de esfuerzo en la mujer.

E.2.2

Secondary objectives of the trial

Obtain some facts about the improved quality of life of treated patients measured with SF-36 test.
Obtain some data security preliminales long term (1 year) of the proposed treatment that allows us to design in future clinical trials with a larger number of patients with the same pathology.

Obtener unos datos sobre la mejora en la calidad de vida de los pacientes tratados mediante un test SF-36.
Obtener unos datos preliminales de seguridad a largo plazo (1 año) del tratamiento propuesto que nos permita diseñar en el futuro un Ensayo Clínico con un mayor número de pacientes frente a la misma patología.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Signature of informed consent.
• Women over 18 years with good general status, according to data from the clinical history and physical examination.
• Women in postmenopausal age or older than 18 who take highly effective contraceptives as ICH guidance (M3) of the EMA indicates.
• Women who have failed rehabilitation treatment or patients who refuse to submit to rehabilitation.
• Women diagnosed with genuine urinary incontinence due to strain or strain predominant mixed with at least 1 year of evolution.

• Firma del consentimiento informado.
• Mujeres mayores de 18 años, con buen estado general, de acuerdo con los datos de la historia clínica y la exploración física.
• Mujeres en edad postmenopausica o mayores de 18 años que tomen anticonceptivos altamente eficaces según la guía ICH (M3) de la EMA
• Mujeres en las que ha fracasado el tratamiento rehabilitador o pacientes que rechazan someterse al tratamiento rehabilitador.
• Mujeres diagnosticadas de incontinencia urinaria de esfuerzo genuina o mixta de predominio de esfuerzo con al menos 1 año de evolución.

E.4

Principal exclusion criteria

- Pregnant or breast-feeding women.
- Present infravesical obstruction (will be discarded by urethrocystoscopy and flowmetry).
- Active urine infection.
- A history of alcohol abuse or other addictive substances in the 6 months prior to inclusion.
- Present any malignancy, except in the case of basocellular carcinoma or epidermoid of skin, or have a history of malignancy, unless they have been found in remission during the previous 5 years.
- Cardiopulmonary disease that, in the opinion of the investigator, is unstable or is sufficiently serious to dismiss the patient from the study.
- Medical or psychiatric illness of any kind that, according to the investigator, may be a reason for exclusion from the study.
- Subjects with congenital or acquired immunodeficiency, Hepatitis B and / or C, tuberculosis or Treponema diagnosed at the time of inclusion.
- Allergy subject to anesthetics.
- Major surgery or major trauma of the subject in the previous semester.
- Administration of any investigational drug at the present time or three months prior to recruitment for this trial.

- Mujeres embarazadas o en periodo de lactancia.
- Presentar obstrucción infravesical (se descartará mediante uretrocistoscopia y flujometría).
- Infección de orina activa.
- Antecedentes de abuso de alcohol o de otras sustancias adictivas en los 6 meses anteriores a la inclusión.
- Presentar cualquier neoplasia maligna, salvo que se trate de carcinoma basocelular o epidermoide de la piel, o presentar antecedentes de tumores malignos, salvo que se hayan encontrado en fase de remisión durante los 5 años anteriores.
- Enfermedad cardiopulmonar que, en opinión del investigador, resulte inestable o revista la gravedad suficiente para descartar al paciente del estudio.
- Enfermedad médica o psiquiátrica de cualquier tipo que, en opinión del investigador, pueda suponer un motivo de exclusión del estudio.
- Sujetos con inmunodeficiencias congénitas o adquiridas, Hepatitis B y/o C, Tuberculosis o Treponema diagnosticados en el momento de la inclusión.
- Alergia del sujeto a los anestésicos.
- Cirugía mayor o traumatismo grave del sujeto en el semestre anterior.
- Administración de cualquier fármaco en investigación en el momento actual o tres meses antes del reclutamiento para este ensayo.

E.5 End points

E.5.1

Primary end point(s)

The primary outcome feasibility and safety study will be performed once the patient has received treatment. To assess the feasibility of the treatment will include a unit in the Data Collection Booklet (CRD), so that the surgical team or cell producer expose the complications that have been around for cell isolation or during surgery (cell implantation). The safety variable is measured at 12 weeks of implant and follow-up year. We define that the process is safe when development and monitoring of the trial has not produced any adverse event that may relate to the proposed therapy in the trial. All clinical adverse events during follow-up will be collected at the same times that the clinical evaluation. The cumulative incidence of adverse effects attributed to therapy in the study will be evaluated as main objective.

La variable primaria de factibilidad y seguridad del estudio se realizará una vez el paciente haya recibido el tratamiento. Para valorar la factibilidad del tratamiento se incluirá un aparatado, en el Cuaderno de Recogida de Datos (CRD), para que el equipo quirúrgico o productor celular exponga las complicaciones que han existido durante el aislamiento celular o durante el acto quirúrgico (implante celular). La variable de seguridad se valorará a las 12 semanas del implante y al año de seguimiento. Se define que el proceso es seguro cuando durante el desarrollo y seguimiento del ensayo no se ha producido ningún acontecimiento adverso que se pueda relacionar con la terapia propuesta en el ensayo. Todos los acontecimientos adversos clínicos 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 el estudio.

E.5.1.1

Timepoint(s) of evaluation of this end point

at 12 weeks of implant and follow-up year

a las 12 semanas del implante y al año de seguimiento

E.5.2

Secondary end point(s)

As part of the evaluation of treatment success will be a clinical examination at 12 weeks after implantation, considering successful treatment when involuntary loss of urine decreases. As part of the evaluation of recurrence will be done a clinical analysis of patients one year later of the cells implant. Both studies will be conducted by clinical investigators of the trial, if there is no agreement in the diagnosis, an urologist from outside of the study will be consulted.

Como parte de la evaluación del éxito del tratamiento se realizará un análisis clínico a las 12 semanas después del implante, considerandose el tratamiento exitoso cuando haya disminuido la pérdida de orina involuntaria. Como parte de la evaluación de recidiva se realizará un análisis clínico de los pacientes al año de implantarse las células. Ambos estudios serán realizados por los investigadores clínicos del ensayo, en caso de no existir acuerdo en el diagnóstico se recurrirá a un urólogo experto ajeno al estudio.

E.5.2.1

Timepoint(s) of evaluation of this end point

at 12 weeks of implant and follow-up year

a las 12 semanas del implante y al año de seguimiento

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

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

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

When a patient is removed from the study for any reason, must be notified and the investigetor will carry out every end of the study procedures. Nevertheless the patient will be asked to come to the consultation at 12 weeks and one year after cell implantation to check for any adverse event has occurred.

Cuando un paciente sea retirado del estudio, por cualquier causa, debe ser notificado y el investigador cuplimentará todos los procedimientos de fin del estudio. No obstante se solicitará al paciente que acuda a la consulta a la semana 12 y al año posterior al implante celular para comprobar si ha ocurrido algún acontecimiento adverso.

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

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)

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

2012-06-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-03-02

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

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