Clinical Trials Register

Summary
EudraCT Number:	2011-001393-26
Sponsor's Protocol Code Number:	EC-INC-09-01
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:	2012-03-29
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

2011-001393-26

A.3

Full title of the trial

Phase II clinical trial to evaluate the feasibility and safety of human adipose derived mesenchymal stem cells on chronic ischaemic stroke.

Ensayo Clínico en fase IIa para conocer la factibilidad y
seguridad del uso alogénico de células madre expandidas derivadas de
la grasa en el tratamiento local del ictus por infarto del territorio de la
arteria cerebral media.

A.3.1

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

Clinical trial to evaluate the feasibility and safety of the intracerebral infusion of stem cells in patients with cerebral stroke

Ensayo clínico para conocer si es segura la administración intracerebral de células madre en pacientes con infarto cerebral.

A.3.2

Name or abbreviated title of the trial where available

Celictus study

Estudio Celictus

A.4.1

Sponsor's protocol code number

EC-INC-09-01

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 Clínico San Carlos
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	Fundación para la Investigación Biomédica del Hospital Clínico San Carlos
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 Clínico San Carlos
B.5.2	Functional name of contact point	Esther Olmedilla
B.5.3	Address:
B.5.3.1	Street Address	Profesor Martín Lagos SN
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28040
B.5.3.4	Country	Spain
B.5.4	Telephone number	0034913303793
B.5.5	Fax number	0034913303515
B.5.6	E-mail	fibucicec.hcsc@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	adiposse tissue stem alogenic mesenchymal cells expanded
D.3.2	Product code	Not applicable
D.3.4	Pharmaceutical form	Infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intracerebral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	mesenchymal stem cells
D.3.9.3	Other descriptive name	ASC
D.3.10	Strength
D.3.10.1	Concentration unit	million organisms/ml million organisms/millilitre
D.3.10.2	Concentration type	equal
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)	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	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	Yes
D.2.1.1.1	Trade name	Tissucol Duo 5,0
D.2.1.1.2	Name of the Marketing Authorisation holder	Baxter SL
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/infusion in pre-filled syringe
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	Tissucol solution
D.3.9.1	CAS number	103170-82-7
D.3.9.3	Other descriptive name	FIBRIN TISSUE ADHESIVE
D.3.9.4	EV Substance Code	SUB33226
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	Yes
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)	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	Yes
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

ischemic stroke

infarto cerebral

E.1.1.1

Medical condition in easily understood language

ischemic stroke

infarto cerebral

E.1.1.2

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

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

Safety evaluation of the intracerebral infusion of adult mesenchymal stem cells in ischaemic stroke.

Evaluación de la seguridad de la administración de células madre
mesenquimales adultas derivadas de tejido adiposo en la fase subaguda del ictus

E.2.2

Secondary objectives of the trial

Evaluation of functional capacity (RMN, FIM, Rankin and Barthel tests)
Evaluation of neurological impairment (NIHSS test)
Evaluation of quality of life (SF-36)

Evaluación de la eficacia en la discapacidad funcional (RMN funcional,
FIM, Rankin y Barthel)
Evaluación de la eficacia en la afectación neurológica (NIHSS)
Evaluación de la eficacia sobre la calidad de vida en las actividades de la
vida diaria (SF?36)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Capacity for sign and understand the informed consent form
2. Age between 25 and 70 years old in the inclusion time
3. Man or woman with middle cerebral artery ischemic stroke at least in the 6 months prior to the inclusion
4. Image techniques showing injuries consistent with complete infarction of middle cerebral artery
5. Patients with severe secuelae verified by a 2 Rankin test level or less

Capacidad para comprender y firmar el consentimiento informado
para la participación del estudio
2. Edad de 25 a 70 años, en el momento de la inclusión.
3. Mujer o varón con el diagnostico de la Ictus por infarto completa de la
arteria cerebral media, por lo menos seis meses antes de la inclusión.
4. RM o TAC craneal que muestre lesiones compatibles con un infarto
completo de la cerebral media.
5. Pacientes con secuelas grave medida por Rankin de 2 o inferior.

E.4

Principal exclusion criteria

1. Patients requiring tracheostomy or non-invasive ventilation for more than 16 hours a day.
2. Presence of multiple lacunar infarcts in CT scan or MRI
3. History of intracranial hemorrhage or subarachnoid hemorrhage.
4. Patients who have used antipsychotics at therapeutic doses in the month prior to inclusion.
5. History of cancer in the three years prior to inclusion.
6. Previous ideas of suicide
7. Patients with known history of alcohol or drugs.
8. Patients with a history of heart disease, renal, hepatic, systemic, immune, that can influence patient survival during the test control.
9. Patients with chronic neurological disease like Parkinson's, tremor, neurodegenerative disease, etc. ..
10. History of uncontrolled hypertension.
11. Pregnant or breast-feeding.
12. Potentially fertile women (no hysterectomy without bilateral ovariectomy or post-menopausal for 12 months) that were not committed to use a medically approved method of contraception while receiving study medication and until the completion of the trial.
13. Patients with planned surgery from any cause.
14. Participating in another clinical trial.
15. Patients with immunotherapy.
16. Patients in a mode of institutionalization on brain injury center.
17. Patient location difficult or not possible.
18. Inability to cooperate with the rehabilitation treatment
19. Any other reason deemed by the researcher can influence the patient or clinical trial for their participation of it.
20. Existence of marked cerebral atrophy on brain MRI
21. Patients with acute or chronic active infection including patients with hepatitis B, hepatitis C and HIV.

1. Paciente traqueotomizado o con ventilación no invasiva durante mas
de 16 horas al día.
2. Presencia de múltiples infartos no?lacunares antiguos en TAC craneal
o resonancia independientes al que motivo el cuadro clínico.
3. Antecedentes de hemorragia intracraneal o hemorragia
subaracnoidea.
4. Pacientes que han usado antipsicoticos a dosis terapéuticas, incluso
para el sueño, en el mes previo a la inclusión.
5. Antecedentes de cáncer en los tres años anteriores a la inclusión.
6. Ideas previas de suicidio
7. Pacientes con historia reconocida de abuso de alcohol o drogas.
8. Pacientes con antecedentes de enfermedad cardiaca, renal, hepática,
sistémica, inmune, que a juicio del investigador puede influir en la
supervivencia del enfermo durante el periodo de control del ensayo.
9. Pacientes con lesiones neurológicas crónicas por otra enfermedad
como parkinson, temblor, enfermedad neurodegenerativa, ELA, etc..
10. Antecedentes de hipertensión arterial no controlada.
11. Mujeres embarazadas o con riesgo de embarazo o en periodo de
lactancia
12. Pacientes con cirugía planificada de cualquier causa.
13. Participantes en otro ensayo clínico.
14. Pacientes con tratamiento inmunoterapico.
15. Pacientes que residen en régimen de institucionalización en centro
de daño cerebral.
16. Paciente con localización difícil o no posible.
17. Incapacidad para colaborar con el tratamiento rehabilitador

E.5 End points

E.5.1

Primary end point(s)

Detection of cumulative adverse events at 12 months classified according to seriousness, intensity and the establishment of a causal relationship with the drug under investigation.

Adverse events spontaneously reported by the patient as well as those detected by the investigator will be assesed.

Detección de acontecimientos adversos acumulados a los 12 meses y clasificados según sean graves o no graves, según su intensidad y según el establecimiento de la relación causal con el medicamento en investigación.

Se evaluarán tanto los acontecimientos adversos objetivados por el equipo investigador, como aquellos reportados espontáneamente por el paciente.

E.5.1.1

Timepoint(s) of evaluation of this end point

1 week and 1, 3, 6 and 12 months after infusion

A la semana y al mes, 3, 6 y 12 meses

E.5.2

Secondary end point(s)

Evaluation of functional capacity by RMN, FIM, Rankin and Barthel tests)
Evaluation of neurological impairment by NIHSS test
Evaluation of quality of life by SF-36

Evaluación de la eficacia en la discapacidad funcional mediante la RMN
(62, 63, 64) funcional y las escalas de Rankin,Barthel y FIM.
Evaluación de la eficacia en la afectación neurológica mediante la
escala de NIHSS
Evaluación de la calidad de vida en las actividades de la vida diaria
mediante el cuestionario de vida SF?36 modificado

E.5.2.1

Timepoint(s) of evaluation of this end point

1 week and 1, 3, 6 and 12 months after infusion

A la semana y al mes, 3, 6 y 12 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

Yes

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)

Yes

E.7.1.1

First administration to humans

Yes

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

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

Yes

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

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

Yes

E.8.2.3.1

Comparator description

No tratamiento. Los pacientes del grupo control no recibirán el medicamento en investigación.

Lack of treatment. Patients in the control group will not receive the medicinal product

E.8.2.4

Number of treatment arms in the trial

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

Yes

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

the last visit of the last subject undergoing the trial

Se considerará el final del ensayo clínico la última visita que realice el último sujeto que haya sido incluido en el estudio.

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

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial 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)

Yes

F.1.3.1

Number of subjects for this age range:

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)

Patients will continue with clinical follow-up at the discretion of the principal investigator

Los pacientes continuarán con seguimiento clínico a criterio del investigador principal

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

2012-10-22

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-09-23

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

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