Clinical Trials Register

Summary
EudraCT Number:	2012-004444-30
Sponsor's Protocol Code Number:	Disc_allo_MSV
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:	2013-02-04
Trial results	View 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

2012-004444-30

A.3

Full title of the trial

Treatment of degenerative disc disease with allogenic mesenchymal cells—MSV--

Tratamiento de la discopatía degenerativa lumbar con células
mesenquimales alogénicas (MSV*).

A.3.1

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

Treatment of degenerative disc disease with allogenic mesenchymal cells—MSV--

Tratamiento de la discopatía degenerativa lumbar con células
mesenquimales alogénicas (MSV*).

A.4.1

Sponsor's protocol code number

Disc_allo_MSV

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	Citospin
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	Citospin
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	Fundacion Teofilo Hernando
B.5.2	Functional name of contact point	Javier Soriano Ventura
B.5.3	Address:
B.5.3.1	Street Address	Avd. Arzobipspo Morcillo 4
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28029
B.5.3.4	Country	Spain
B.5.4	Telephone number	34915202425
B.5.5	Fax number	34915202425
B.5.6	E-mail	javier.soriano@uam.es

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	Mesenquimal stem cells
D.3.2	Product code	MSV
D.3.4	Pharmaceutical form	Suspension for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intradiscal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ringer lactate solution
D.3.9.1	CAS number	8026-79-7
D.3.9.3	Other descriptive name	RINGER'S LACTATE SOLUTION
D.3.9.4	EV Substance Code	SUB33298
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	2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Glucose
D.3.9.3	Other descriptive name	GLUCOSE
D.3.9.4	EV Substance Code	SUB13981MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mmol millimole(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)	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	Mepivacaina Inyectable
D.2.1.1.2	Name of the Marketing Authorisation holder	B.Braun Medical S.A
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.3.1	Product name	Mepivacaina Inyectable
D.3.2	Product code	Control
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	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	MEPIVACAINE
D.3.9.1	CAS number	96-88-8
D.3.9.4	EV Substance Code	SUB14514MIG
D.3.10	Strength
D.3.10.1	Concentration unit	% percent
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2
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	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

Treatment of degenerative disc disease

Tratamiento de la discopatía degenerativa

E.1.1.1

Medical condition in easily understood language

Treatment of degenerative disc disease

Tratamiento de la discopatía degenerativa

E.1.1.2

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

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

Feasibility and security of MSV cells local use for degenerative disc disease treatment.

Evaluar la factibilidad y seguridad del uso local de las MSV alogénicas para el
tratamiento de la discopatía degenerativa lumbar.

E.2.2

Secondary objectives of the trial

- Efficacy of treatment with MSV allogenic cells.
- Monitoring the progress of discal dehydration by MRI T2 calibrated.
- compare the efficacy of treatments in experimental and control arms.

Evaluar la eficacia de los tratamientos con MSV alogénicas mediante criterios de
evolución clínica objetivada por los cuestionarios de dolor lumbar (Escala Visual Analógica, EVA), discapacidad (cuestionario de Oswestry) y calidad de vida (cuestionario SF-36 en su versión abreviada, SF-12).
 Seguimiento de la evolución de la deshidratación discal por las imágenes de resonancia magnética calibradas en T2.
 Comparar la eficacia de los tratamientos en los brazos control y experimental.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Lumbar degenerative disc disease of one or two disks with predominant low back pain and / or sciatica persisting after conservative treatment (medical and physiotherapy) over 6 months.
2. Full annulus, capable of holding cell implantation, demonstrated in the MR image (stages 2, 3 and 4 of Adams) (Adams et al., 2000).
3. Decreased disc space height of more than 20% measured
radiographically in lateral view.
4. Absence of spinal infection.
5. Hematological and biochemical analysis without significant alterations that contraindicate surgery
6. The patient is able to understand the nature of the study.
7. Written informed consent of the patient.

1. Discopatía degenerativa lumbar de uno o dos discos con predominio de dolor lumbar y/o ciatalgia persistente tras tratamiento conservador (médico y fisioterápico) de más de 6 meses de evolución.
2. Anillo fibroso íntegro, capaz de contener el implante celular, demostrado con en la imagen de RM (estadios 2, 3 y 4 de Adams) (Adams et al., 2000).
3. Disminución de la altura del espacio discal de más del 20 % medido
radiograficamente en imagen lateral.
4. Ausencia de infección espinal.
5. Análisis hematológicos y bioquímicos sin alteraciones significativas que contraindiquen la intervención
6. El paciente es capaz de entender la naturaleza del estudio.
7. Consentimiento Informado por escrito del paciente.

E.4

Principal exclusion criteria

1. Age under 18 or over 75 or legally dependent
2. Allergies gentamicin or bovine sera, bovine or equine.
3. Congenital or acquired deformities of the spine significant obstacles to the application.
4. Pathology conditional spinal segmental instability, spinal canal stenosis, isthmus pathology and other disturbances that might compromise the study at the discretion of the investigators
5. Presence of Modic changes III in MRI images (Modic & Ross, 2007)
6. Excess weight with body mass index (BMI) greater than 35
7. Pregnancy or breastfeeding
8. neoplastic disease
9. Immunosupresive situation.
10. Participation in another clinical trial or treatment with another investigational product within 30 days prior to inclusion in the study.
11. Any other condition or circumstance that would compromise participation in the study medically

1. Edad menor de 18 años, o mayor de 75 años o legalmente dependiente
2. Alergias a gentamicina, o a sueros bovinos, vacunos o equinos.
3. Enfermedades congénitas o adquiridas con deformaciones significativas de la columna vertebral que dificulten la aplicación.
4. Patología vertebral que condicione inestabilidad segmentaria, estenosis del canal medular, patología del istmo y otras alteraciones que pudieran comprometer el estudio según criterio de los investigadores
5. Presencia de cambios Modic III en las imágenes de RNM (Modic & Ross, 2007) (Anexo VIII).
6. Sobrecarga ponderal con índice de masa corporal (IMC) superior a 35
(obesidad grado II; SEEDO), siendo IMC= masa en Kg / (altura en m)
2
7. Embarazo o lactancia
8. Enfermedad neoplásica
9. Estados inmunosupresivos
10. Participación en otro ensayo clínico o tratamiento con otro producto en fase de Investigación en los 30 días previos a la inclusión en el estudio.
11. Cualquier otra patología o circunstancia que comprometa la participación en el estudio según criterio médico

E.5 End points

E.5.1

Primary end point(s)

The objective is to evaluate the efficacy by clinical criteria (visual evaluation Lumbar pain Visual Analog Scale (VAS) Oswestry Disability Index - ODI - index of quality of life - SF-12 -), and imaging (MRI quantitative) at 6 and 12 months of
intervention.

El objetivo es la evaluación de la eficacia mediante criterios clínicos (Evaluación visual analógica del dolor lumbar—EVA--, Índice de discapacidad de Oswestry --ODI--, Índice de de calidad de vida --SF-12--), y de imagen (RM cuantitativa) a los 6 y 12 meses de la intervención.

E.5.1.1

Timepoint(s) of evaluation of this end point

12 months

12 meses

E.5.2

Secondary end point(s)

no applicable

no aplica

E.5.2.1

Timepoint(s) of evaluation of this end point

no applicable

no aplica

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

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

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)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

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

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

Last patient last visit

Ultima visita del ultimo paciente

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)

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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)

standard care

Tratamiento habitual

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

2013-04-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-12-20

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

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Orphan Designation Number:
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